Detection of infectious disease promptly and accurately is important because the burden of infectious disease is high.  In the United States, chronic lower respiratory diseases were the third leading cause of death in 2015, behind only heart disease and cancer.  The Center for Disease Control and Prevention (CDC) reports that 155,041 people died in the United States in 2015 due to chronic lower respiratory diseases.

Infectious diseases are all the more troubling because they may harm long after the disease is treated.  These secondary effects – cancer, heart disease – increase the stakes and suggest the need for testing. 

Clinical microbiology laboratories perform tests to detect, isolate, identify and characterize microorganisms that cause infectious diseases, and also perform antibiotic susceptibility tests.   Traditional microbiology, including culture, microscopy, use of stains plus fluorogenic and chromogenic substrates, and other technologies has b used for several decades in microbiology laboratories.  Microbiology tests may be performed using traditional microbiology techniques, or by using newer technologies including immunoassays, molecular microbiology (PCR or other nucleic acid amplification methods), or mass spectrometry.

The following represent recent developments in microbiology that are innovative.  For each, we’ve detailed the company, the area the development is in (disease being treated or general procedure such as blood culture), the location of the company so that interested readers can pursue them, and the detail on the innovation and the status (FDA or CE cleared, market = marketed for some time, service, RUO or other).

This table represents some recent innovations in infectious disease diagnostics.  For more analysis please see our Infectious Disease World Market Analysis report.

Company Location Area Details Stats
Abbott Abbott Park, IL flu a/b, strep A ID NOW CLIA Waived POC FDA
Abbott Diagnostics U.S. various Iridica molecular-testing platform CE
Abbott Diagnostics U.S. HIV ARCHITECT HIV Ag/Ab Combo assay FDA
Accelerate Diagnostics U.S. blood culture CRE in blood culture dev
Accelerate Diagnostics U.S. blood culture BacAccelerate ID/AST Blood Culture Assay CE
Advanced Biological Lab Luxembourg HCV Anti-E1/E2-based ELISA for HCV management dev
AdvanDx U.S. blood culture Candida QuickFISH CE
AdvanDx U.S. blood culture gram-positive/negative QuickFISH CE
AdvanDx U.S. HAIs mecA XpressFISH, MRSA FDA
Alere U.S. HAIs BinaxNOW PBP2a test CE, FDA
Alifax Italy blood culture Automated blood culture FDA,CE
Aperiomics U.S. microbiome Absolute-Biome, microbiome sequencing RUO
Aseptika Limited UK resp inf bacterial protein in sputum, CF, asthma, COPD CE
Atomo Diagnostics Australia panel AtomoRapid dengue and chikungunya dev
Beckman Coulter Brea, CA Sepsis Early Sepsis Indicator DxH900 Hematology System CE
Biocartis Switzerland ebola Ebola test with Janssen Diagnostics on Idylla dev
Biohit OYJ Finland microbiome Genetic Analysis AS’s Dysbiosis microbiome for IBD CE
BioInnovation Solutions Switzerland filoviruses, such as Ebola and Marburg dev
bioMereiux France various AE-180 /AE-240 mid throughput immunoassay system FDA
bioMereiux France pneumonia 18 bacteria/8virus/7gene panel
bioMérieux France mass spec assays for Knome sequencing platform dev
bioMérieux France ID/AST VITEK MS, ID/AST on Shimadzu mass spec CE, FDA
bioMérieux France ID/AST BacT/ALERT Virtuo, 15 min result mkt
Bioneer Corp Korea Ebola AccuPower EBOV real-time RT-PCR RUO
Bioneer Corp Korea Zika AccuPower ZIKV Multiplex Zika, dengue, CHIKV CE
Bioneer Corp. Korea Ebola AccuPower EBOV real-time RT-PCR Nigeria
Bio-Rad Hercules, CA malaria multiplex MAG PIX FDA
Bruker Biosciences U.S. blood culture MALDI Sepsityper Solution, positive blood culture CE
Bruker Biosciences U.S. blood culture integrate MALDI Biotyper with BD Phoenix dev
Cajetmo Heredin University Lima, Peru chagas qPCR on clot samples low blood leads dev
Canon BioMedical U.S. Lyme with T2 Biosystems, Lyme Disease, PCR dev
Cepheid U.S. TB Xpert MTB/RIF, TB & rifampin-resistance FDA
Cepheid U.S. TB Xpert XDR-TB, extensive drug resistance, PCR dev
Cepheid U.S. ebola Xpert Ebola, PCR EUA
Cepheid U.S. MRSA Xpert MRSA/SA Blood Culture (BC) FDA
Cepheid/Danaher HIV Gene Expert HIV-1 Qual FDA
Ceres Nanosciences U.S. lyme Nanotrap Lyme Antigen (LA) Test srvc
Chembio Diagnostics U.S. ebola DPP Ebola with Integrated BioTherapeutics dev
Chembio Diagnostics U.S. zika zika added to DPP Fever Panel assay dev
Chembio Diagnostics U.S. malaria DPP Malaria dev
ChromaCode Carlsbad, CA tick-borne 12 spiecies tick panel service
Co-Diagnostics HBDC U.S. TB LogixSma-RT TB Kit mkt
Coris BioConcept Belgium chagas T. cruzi satDNA OligoC-TesT, PCR mkt
CTK Biotech U.S. CHICKV OnSite Chikungunya IgM Combo Rapid Test CE
Curetis AG Germany response Acumen’s AcuSept panel, sepsis immune response dev
DiaSorin Italy campy LIAISON Campylobacter stool test mkt
DiaSorin Italy GI Liaison bacterial stool-testing panel CE
Diaxonhit France avidity portfolio active vs older infections mkt
Diaxonhit France sepsis BJI InoPlex test staph antibodies in blood CE
DiscoGnosis Project EU panel LabDisk 12 pathogens- malaria, dengue, CHICKV dev
DNA Genotek/OraSure Canada microbiome OMNIgene•GUT microbiome collection kit, stool self collect CE, RUO
DPZ Diagnostics Germany ebola Diagnostics-in-a-Suitcase dev
DxNA U.S. Valley Fever Valley Fever (coccidioidomycosis) dev
Dynamiker Biotechnology China fungi ELISA invasive fungal disease CE
EKF Diagnostics UK sepsis Stanbio LiquiColor Procalcitonin, automated analyzers CE
EliTech Group South Logan, UT HSV 2 multiplex six channel test
Enigma Diagnostics UK TB MDR-TB on Enigma Mini Laboratory dev
Epistem Holdings UK TB Genedrive TB and resistance CE
Fast-Track Diagnostics Luxembourg Ebola FTD Ebola assay CE
Fio Corporation Canada ebola Corgenix ReEBOV Ebola antigen on Deki Reader EUA; FDA
Fio Corporation Canada lassa Corgenix ReLASV Lassa virus antigen on Deki Reader CE
Fio Corporation Canada micro Deki Reader Malaria & Dengue, LF CE
GBDbio U.S. TB TB REaD POC test, fluorescent beta lactamase enzyme dev
Genalyte Inc. U.S. ebola Ebola antigens and IgM/IgG antibodies dev
Genalyte Inc. U.S. ebola Ebola antigens and IgM/IgG antibodies dev
GenArraytion U.S. zika MultiFlex Mosquito-borne Panel, zika etc RUO
GeneDrive Manchester, UK Hepatitis C Genedrive POC HCV ID Kit CE
GeneDrive Manchester, UK
GeneDrive Manchester, UK hep C 100% specificity test CE
Genetic Analysis Norway microbiome Dysbiosis test microbiome imbalance in irritated bowel syndrome CE
Global BioDiagnostics UK TB TB, Reporter Enzyme Fluorescence dev
Globavir Biosciences U.S. dengue PanGlob RT-PCR Dengue market
Gold Standard Diagnostics U.S. syphilis AIX1000 Rapid Plasma Reagin (RPR) Automated FDA
Great Basin Scientific U.S. PCR Staph ID/R Blood Culture Panel FDA
Hain Lifescience Germany TB GenoType MTBDRsl, colonies & sputum CE
ICDPR Dhaka, Bangledesh cholera Cholkit Dipstick Assay market
Inflamatix Burlingame, CA Sepsis multigene sepsis panel dev
Institute for Preventitive Research Gottigen, Germany treporema Pallidum LAMP technology dev
Jena University Jena Germany MIC MIC determinaion in two hours with LOC tech. dev
LabCorp U.S. Zika Altona’s RealStar Zika Virus RT-PCR Kit srvc
Luminex Austin, TX flu a/b Aries FDA
Luminex Austin, TX GI Verigene II GI assay dev
Luminex U.S. panel GenArraytion MultiFlex Mosquito-borne Panel- Zika, CHICKV, Dengue dev
Lumora UK malaria malaria test, LAMP, with FIND and Eiken mkt
Magnolia Medical San Mateo, CA blood culture U South Car. Study shows 4 fold decrease in contaminiation study
Mass. Institute of Technology U.S. panel Matrix Multiplexed Diagnostic – ebola, dengue, yellow fever dev
Mayo Medical Lab U.S. microbiome microbiome diagnostics on Whole Biome’s Complete Biome Test service
MBio Diagnostics U.S. malaria LightDeck Malaria cartridge dev
MBio Diagnostics U.S. malaria LightDeck Malaria cartridge dev
MBio Diagnostics U.S. instr LightDeck, multiplexed immunoassay platform, cartridge dev
Medical Innovation Ventures Malaysia dengue ProDetect Dengue tests CE
MeMed Diagnostics Israel response ImmunoXpert pathogen immune response proteins CE
Meridian Bioscience Cincinatti, OH CMV Althethia CMV Test FDA
Meridian Biosciences U.S. TB illumigene Mycoplasma Direct assay, improved CE, FDA
Meridian Biosciences U.S. dengue TruQuik CE
Meridian Biosciences U.S. malaria illumigene Malaria CE
Milford Molecular Diagnostics U.S. ebola Ebola RT-PCR srvc
MIT Cambridge, MA gene editing SHERLOCK Diagnostic Platform cas13 dev
Nanologix U.S. instr NanoLogix N-Assay, ELISA dev
OmniBiome Therapeutics U.S. microbiome maternal infections that lead to preterm labor service
OraSure Technologies U.S. ebola OraQuick Ebola Rapid Antigen Test EUA
Ortho Clinical Diagnostics Raritan, N.J. HIV HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) FDA
Quansys Biosciences U.S. resp 14‐plex Pneumococcal Array dev
Quidel San Diego, CA h. pylori Quick chaser test
Quidel San Diego, CA viral gastroenteritis Solana GAS assay small footprint
Quidel U.S. resp Sofia RSV Fluorescent Immunoassay waived
Quidel U.S. resp Sofia Strep A+ Fluorescent Immunoassay waived
Qvella Corp Canada sample Field Activated Sample Treatment pathogen concentration & Dx dev
Research & Diagnostic Antibodies U.S. sepsis PliNOSa Assay Kit CE
Response Biomedical Canada sepsis RAMP Procalcitonin CE
Roche Indianapolis, IN zika cobas zika test 6800/8800 pooled assay FDA
Roche Indianapolis, IN CT/NG RT PCR cobas FDA, CE
Roche Indianapolis, IN HPV cobas 6800/8800 FDA
Sandia National Labs Livermore, CA choldera, staph, e.coli combined immunoassay and NAAT service
Siemens Healthineers Tarrytown, NY hep/HIV HIV, CHIV, EHIV and viral hep. Tests for Attelica Solution pre-market approval FDA
Singulex U.S. pathogens single-molecule counting technology dev
Stellenbosch University South Africa TB Risk 4 test for TB dev
Sysmex Kobe, Japan various UF-5000 blue laser flow cytometry market
Thermo Fisher Scientific U.S. MERS Middle East Respiratory Syndrome Coronavirus (MERS-CoV) EUA
Thermo Fisher Scientific U.S. flu CDC’s influenza A (H7/N9) virus EUA
Transasia Bio-Medicals India STD ErbaLisa Syphilis mkt
U. of California, Irvine U.S. HCV HCV-AGS EIA acute HCV in urine dev
uBiome U.S. microbiome SmartGut, fecal sample seq for a microbiome study of the gut service
University Hopsital Cologne, Germany HAIs rapid test for carbapenmases dev
University of Hong Kong Hong Kong RSV saliva test for respiratory disease dev
USC Los Angeles, CA malaria PODS early stage malraia optics technology dev
ViroCyt U.S. sample ViroTag & Virus Counter 3100 dev

1.5 Billion Yet-Unclaimed Revenue in The LATAM IVD Market: Report

There is IVD sold almost everywhere in the world but revenue growth is not found everywhere. For most of the top IVD companies, adding scores of millions in growth would be helpful to business plans. That’s why growth regions such as Latin America offer promise beyond their market size. The maturation of IVD markets in developed countries (growth rate 1%-2%) has IVD companies casting their nets in developing countries where rising incomes and standards of living are anticipated to spark a new health consciousness population with growing demands for quality medical care.

A New Report From Kalorama Information Projects $1.5 Billion in as-yet-unclaimed market dollars in the Latin American in vitro diagnostics market in the next five years.

Latin America (LATAM) is a key target for IVD manufacturers.  Kalorama’s report, IVD in Latin America, focuses on the market for reagents and instruments in the most important countries of the continent. Argentina, Brazil, Chile, Colombia, Mexico, and Peru are singled out for a deeper level of analysis; the countries of Bolivia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Guyana, Haiti, Honduras, Nicaragua, Panama, Paraguay, and Uruguay are also considered to provide a complete overview of the region. Combined, these countries represent a population of 626.5 million; a large potential IVD market audience. Brazil and Mexico represent the two largest countries in terms of population, accounting for more than half of LATAM total population. For this reason, these two countries have been the focus for many IVD suppliers in recent years.

However, as economic conditions strengthen in other countries and demand increases for quality health services, there are additional opportunities in countries such as Argentina and Chile.

The estimated GDP for the countries studied in this research is an average of 0.1% annual growth for the year 2017 but consists of a declining GDP for Venezuela; excluding Venezuela, the region records 2.2%. GDP per capita is reported at $16,635 on average for the region.

Inequalities and social deprivation are always present in Latin America, where poverty is not declining; in fact, it sometimes increases. Although not all the countries in Latin America present similar circumstances or have the same players, there is a permanent and historical social inequality present in all countries of the region. Throughout the region there are highly educated citizens with high economic income; while there are also citizens without or with low education with financial struggles.

Over the last years, the countries in the Atlantic zone grew more rapidly than those in the Pacific zone, basically because of the rise in the price in commodities, currently slowing and declining. Venezuelan, Argentinian and Brazilian currencies have experiences wide currency fluctuations, mostly declining in value. Additionally, both Argentina and Venezuela are going through a high inflation rate process.

The total revenues calculating the IVD market in LATAM are generated by the sales of reagents, consumables, controls, calibrators and solutions categorized in well-defined segments. The market for IVD in Latin America is estimated at $2.4 billion in 2018 and will grow at 8.4%. That’s nearly one billion and a half dollars of extra market value that companies will compete for. Population growth, government insurance, newly insured patients and updated healthcare facilities will drive growth.

Brazil is the largest in vitro diagnostics market within Latin America and represents 45% of the market. Mexico ranks second with an estimated 19%.  Brazil, Chile and Colombia are among the highest growers.

Key IVD Market Competitors in Latin America

Abbott

Abbott Laboratories is a global, diversified healthcare company active in pharmaceuticals, nutritionals, devices and diagnostics. Abbott’s diagnostic product strength is its sheer presence worldwide. In LATAM, the company dominates in immunoassay-based microbiology and molecular microbiology, and is competitive in all countries in immunoassays.

Market Share for IVD Players in Latin America with rankings can be found in Kalorama Information’s New Research Report on Latin American IVD

Danaher

Beckman Coulter, Inc., a subsidiary of Danaher Corporation (DHR), has developed, manufactured, and marketed IVD tests for more than 75 years. The company reports that more than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on six continents.   Beckman Coulter’s strength is in chemistries, immunoassays, flow cytometry and hematology.   Danaher also operates the blood analyzer leader, Radiometer, and histology leader Leica Biosystems.

Becton Dickinson

Becton Dickinson (BD) is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry, and the general public.  BD has operated in China since 1994 and in India since 1996. In LATAM, the company specializes in microbiology, flow cytometry, and molecular solutions.

bioMérieux

bioMérieux is present in more than 150 countries through 39 subsidiaries and a large network of distributors. bioMérieux is best known for its microbiology business that includes immunoassays, traditional microbiology, and chromogenic media; however, the company is moving to capitalize on its acquisition of Organon Technika’s molecular technology, BOOM, and NASBA technologies.

Roche

Roche Diagnostics dominates clinical chemistry, urinalysis, POC, and hematology and is competitive in molecular and immunoassays. Roche is the world’s largest supplier of clinical diagnostics products; Roche’s global product sales are still almost twice its nearest competitor. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools for patient disease management. Roche’s Ventana Medical Systems business also contributes to their market strength.

Siemens Healthineers

The Siemens Healthineers business is one of the world’s largest suppliers to the healthcare industry and a major player in medical imaging, laboratory diagnostics, medical information technology, and hearing aids. The diagnostics division includes products for clinical chemistry, drug testing, hematology, coagulation, immunoassay, infectious diseases, microbiology, molecular diagnostics, plasma proteins, point of care testing, blood gases/electrolytes, and urinalysis. In addition, Siemens operates a clinical laboratory and offers laboratory informatics and automation.

Two big developments in direct-to-consumer testing in October.  While one lab giant has teamed up with a major drugstore retailer to offer consumers the ability to test themselves at portals, another has opened it’s website to online tests.  We cover direct to consumer testing, routine and genetic, in our market research report on the topic. (https://www.kaloramainformation.com/Direct-Consumer-DTC-9588755/).  An updated study is planned in January.

It was previously thought that the space where consumers would be most likely to order testing would be in the genetic space, where companies like 23andMe and Ancestry.com have signed up subscribers to have DNA samples taken to detect nationality and ancestry.  These of course are target customers for health and wellness genetic tests.

On the routine side we forecasted a small growthy market but we were less sanguine.  Theranos, was, at the time of the reports publication showing the first signs of its downfall.  Retail outlets like AnyTestNow attempted the concept, and to a degree they still exist and prosper in scale, but their market exposure is limited. There aren’t locations everywhere.  Our optimistic forecasts considered that large players in test performance would enter the space.

Now two developments have occurred in routine patient testing to take note of:

Quest has launched QuestDirect, an enhanced consumer-initiated testing service that empowers patients to manage and take control of their healthcare by ordering health and wellness lab testing from the convenience of their home.    To order, consumers can visit the QuestDirect website to conveniently shop online and choose their own lab tests. Independent physicians will provide oversight and, if appropriate, order the testing. Consumers can make an appointment online to visit one of Quest’s 2,200 patient service centers. Results are typically available within a week and can be accessed through MyQuest, where they can be easily shared with a consumer’s own doctor, or a with a family member through the new “My Circle” feature that allows approved family members and other users to connect through MyQuest.  Complete blood counts, complete molecular profiles, urine tests, are among those that can be utilized.

The entire clinical lab services market is premised on patients visiting doctors at a normal rate and physicians ordering tests as needed.  There never seemed to be a reason to think that would change, until now.

Similarly, Walgreens and LabCorp announced a large-scale expansion of their LabCorp at Walgreens collaboration. The two companies have agreed to open at least 600 LabCorp patient service centers at Walgreens stores across the U.S. over the next four years, inclusive of the 17 locations that have opened since they first announced their consumer-focused initiative in June 2017.  LabCorp at Walgreens locations are currently open in Florida, Colorado, North Carolina and Deerfield, Illinois, serving as an important part of LabCorp’s network of nearly 2,000 patient service centers across the U.S. Consumers and healthcare providers continue to have a positive response to the existing locations, which offer specimen collection services for LabCorp testing in a secure, comfortable environment. The sites are located near the pharmacy area inside the Walgreens store, providing a convenient location for consumers to access important health services and information.

It should be noted that both moves are early and are launched in a moment where the average consumer does not know tests and what they mean.  They know they have blood taken, and may be aware of a few key tests, such as cholesterol and glucose.  Greater knowledge of tests, and their meanings, may lead to increased demand. When a “CBC” still means to a lot of consumers, The Canadian Broadcast Company?  if it means anything at all, there’s a limit to the market. When everyone, or their apps knows what a CBC that could seriously disrupt testing markets.

It’s too early to tell the impact of direct-to-consumer testing though on the extreme end of prediction, the stakes are high.  The entire clinical lab services market is premised on patients visiting doctors at a normal rate and physicians ordering tests as needed.  There never seemed to be a reason to think that would change, until now.  An additional volume of tests from consumers bypassing the doctors office visit, likely fueled by technology that facilitates the origination and interpretation of tests, and generally, greater knowledge of tests by informed consumers could push clinical lab services markets (market opportunity/demand for the performance of tests) beyond previous estimates.  This also means the markets for in vitro diagnostic instruments and reagents could be augmented in a similar fashion.  Time will tell; it has been Kalorama’s practice to be conservative on such forecasts.

HIV remains a deadly disease, but fortunately, in vitro diagnostic solutions abound for its detection and progress-tracking of treatments.  In this article, we chronicle the developments in HIV IVD – more information can be found in our Worldwide Market for In Vitro Diagnostics Tests, 11th Edition: https://www.kaloramainformation.com/Worldwide-In-Vitro-Diagnostic-Tests-11th-Edition-11723890/

Many of the 35.3 million people infected with HIV worldwide are unaware of their condition, as symptoms may not always be apparent.  A few weeks occur between contamination and the appearance of the first anti-HIV serum antibodies. This makes early detection of seroconversions a focus for healthcare providers and the IVD vendors that serve them.  Fortunately, there are an array of in vitro diagnostic solutions to the detection, identification and prognosis assessment of HIV:

New Small-Hospital Analyzer HIV Test: Ortho Clinical Diagnostics announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for use on Ortho’s VITROS® ECi/ECiQ Immunodiagnostic Systems. The product is aimed at the small hospital market and is sold in and outside the U.S. The VITROS® HIV Combo test was previously approved for use on Ortho’s VITROS® 5600 Integrated System and Ortho’s VITROS® 3600 Immunodiagnostic System. VITROS® HIV Combo, a fourth-generation test, detects both HIV-1 and HIV-2 antibodies (Ab) and the p24 antigen (Ag), enabling detection of acute HIV-1 infection earlier than third-generation tests, according to the company.

Roche’s Plasma Separation Card: In January 2018, Roche announced the launch of its cobas Plasma Separation Card, a simple and stable device for the collection of plasma for HIV viral load testing, with Roche’s cobas AmpliPrep, cobas TaqMan, and cobas 6800/8800 HIV tests. The device requires only a small volume of blood taken the patient’s fingertip, and can be transported with the need for cold storage, making the Plasma Separation Card ideal for use in remote areas and those of extreme temperature and humidity.

Recent Use: In August 2018, Roche installed the system at the Kenya Medical Research Institute (Kemri). for testing in remote areas months after it launched its Cobas Plasma Separation Card. The easy-to-use sample collection device will make it possible to transport plasma for testing in far-flung regions without the use of refrigeration. The machine can handle up to 960 samples within an eight-hour shift compared to the one-month span it traditionally took patients to get results. The Cobas 8800 instrument installed at the Kemri has a capacity to test more than 300,000 Kenyans living with HIV annually.

Using Dentists for HIV Screening: Dental clinics may provide expanded opportunities for oral HIV rapid testing and conversations about HIV prevention in high HIV prevalence communities. A recent study assessed HIV testing in dental clinics in South Florida, an urban area with the highest rates of HIV diagnoses in the United States in 2015. During 2014 and 2015, dentists and hygienists at two federally qualified health center (FQHC) dental clinics who serve racial/ethnic minority patient populations in South Florida were trained to administer oral HIV rapid tests as a part of a routine dental visit.   Expanding HIV screening for populations at risk necessitates testing in nontraditional settings. Patients presenting for dental services were offered a rapid HIV test and brief survey regarding their demographics, HIV testing history and behaviors. Most (85%) accepted oral HIV rapid testing (none tested HIV-positive); 14% had never been tested for HIV.

Latent HIV Quantification: A latent HIV reservoir is a group of immune cells in the body that are infected with HIV but are not actively producing new HIV. Latent HIV reservoirs can hide cells for years, and they can “wake up” and start making more HIV. If someone with HIV is not taking HIV medicines when this happens, the level of HIV in their body (called the viral load) will start to increase. The University of North Carolina at Chapel Hill (UNC) HIV Cure Center and Cell Microsystems, a provider of instruments for the sorting and isolation of single cells, have received an approximately $283,000, 12-month Phase I Small Business Innovation and Research contract from the National Institutes of Health to develop an automated platform to quantify the latent HIV reservoir. As researchers develop therapies to reverse HIV latency—a step toward clearing the virus from the body—an accompanying diagnostic test is also needed to accurately measure the viral reservoir and judge the efficacy of these new latency reversal agents. The collaboration between UNC and Cell Microsystems aims to fill this need by using Cell Microsystems automated images analysis tools, the CytoSort Array and CellRaft AIR system, to screen and isolate thousands of patient-derived cells to detect emergence of HIV after exposure to potential therapeutics.

Mobile HIV-1/2 Test: Arkansas-based start-up NOWDiagnostics is working on a handheld device for fingerstick blood tests called the Lateral Flow Reader that “can be adapted for almost any qualitative or quantitative rapid test.” The company’s ADEXUSDx hCG pregnancy test received 501(k) FDA clearance in 2015. The company’s HIV-1/2 Antibody Test has received CE mark in Europe. The test is an immunochromatographic assay used for the qualitative detection of antibodies against human immunodeficiency virus (HIV) in human whole blood, plasma or serum samples. Each cartridge takes a single drop of blood and returns a result in minutes. There are other tests that are used to measure the severity or monitor therapy of HIV infection such as CD4 count and the viral load test. HIV antibody detection based rapid test is the most appropriate test for routine diagnosis of HIV infection among adults.

Nanophone Technology: Investigators at Brigham and Women’s Hospital have designed a portable and affordable mobile diagnostic tool, utilizing a cellphone and nanotechnology, with the ability to detect HIV viruses and monitor its management in resource-limited regions. The novel platform was described in a paper published recently in Nature Communications. Utilizing nanotechnology, a microchip, a cellphone and a 3D-printed phone attachment, the researchers created a platform that can detect the RNA nucleic acids of the virus from a single drop of blood.

Rapids: Rapid (point-of-care) tests can be conducted away from laboratory facilities and give results in less than 30 minutes. A reactive results from a rapid should be followed up with a lab based test. Among marketed rapids:
• Alere Determine HIV–1/2 Ag/Ab Combo
• Chembio HIV 1/2 STAT-PAK® tests
• Uni-Gold™ Recombigen® HIV-1/2
• OraQuick® HIV Self-Test (HIVST)

Other HIV Testing Systems: There are scores of HIV IVD tests on the market. Besides the tests mentioned, other significant marketed tests include:
• Hologic Aptima HIV-1 RNA Qualitative Assay
• Abbott ARCHITECT HIV Ag/Ab Combo Assay
• Siemens ADVIA Centaur HIV Ag/Ab Combo (CHIV) Assay
• Roche Elecys HIV combi PT
• Bio-Rad GS HIV Combo Ag/Ab EIA
• bioMérieux VIDAS HIV DUO Ultra

Poor Trending with Youth Testing: Testing for HIV is at a crossroads as the youngest and most exposed population seems to be trending against getting tested for AIDs. According to a study published by the CDC in 2018, In the United States, 38.8% of women and 53.8% of men aged 15 to 44 reported they had never been tested for HIV outside of donating blood or blood products. Yet among those 15 to 24, the percentage who reported they had never been tested soared to 63.9% of women and 73.7% of men.
The most common reason reported by women and men for having never been tested was that they thought they were “unlikely to have been exposed to HIV,” or “never offered a test,” which indicates both This roughly matches a previous study, conducted by CDC researchers and published in the journal Pediatrics in 2016, found that the percentage of young adults aged 18 to 24 who reported they have never been tested for HIV remained steady among young men, and increased significantly among young women between 2011 and 2013. Specifically, among all young women, a significant decrease in the prevalence of HIV testing was detected overall, from 42.4% ever being tested in 2011 to 39.5% in 2013, according to that previous study, which was based on data from the national Youth Risk Behavior Survey and Behavioral Risk Factor Surveillance System.

Opt-Out HIV Testing and Other Solutions: The results have surprised experts given the amount of public education and the many HIV testing options available to the public, from at-home HIV testing kits to community health events that involve HIV testing. The decline of AIDs as a large scale national public health issue is a problem, or its status as an episodic event are possible factors. There are some calls for HIV testing to be added to common tests and conducted every year or every six months, at least for certain age groups. Other arrangements for opt-out type testing in certain areas. Opt-out HIV screening is performing an HIV test after notifying the patient that the test will be done; consent is inferred unless the patient declines. A study in San Francisco found that opt-out testing greatly increases test acceptance (https://www.jwatch.org/na40265/2016/02/04/opt-and-opt-out-hiv-testing-revisited).

Kalorama’s market forecasts for multiple types of clinical testing, including HIV testing, can be found in its Worldwide Market for In Vitro Diagnostics Tests, 11th Edition: https://www.kaloramainformation.com/Worldwide-In-Vitro-Diagnostic-Tests-11th-Edition-11723890/

When Columbia University posted a press release in February 2018 about a promising new proof-of-concept study of the Tick-Borne Disease Serochip (TBD Serochip), the press office soon had to amend the announcement with an update for the public: no, the test is not available yet; no, you can’t enroll in a clinical trial or send specimens; and no, they don’t know when it will be ready.

Has the university received a lot of public inquiries about the TBD serochip?

“Indeed we have!” said Tim Paul, editorial director of communications, via email.

The excitement around the TBD Serochip is just one sign of how eager the public is for a better tick-borne disease test.

Lyme disease and other tickborne diseases are on the rise in the United States. As the geographic range of ticks expands, perhaps due to climate change, infections are occurring in new locations. The number of reported tickborne diseases more than doubled in the United States between 2004 and 2016, according to the U.S. Centers for Disease Control and Prevention.

Lyme disease treatment – an oral antibiotic against the Borreliaburgdorferi bacterium — is most effective when administered in the early stages of infection. Delayed treatment can lead to long term damage to the nervous system or joints, and many patients fear the disease will become chronic if diagnosed late (although the CDC maintains that most people respond well to treatment even in later stages of the disease).

Yet diagnosing Lyme disease early can be tricky. Many patients do not notice the initial tick bite and early symptoms of Lyme disease may be vague. Only 70 to 80 percent of infected individuals develop a telltale erythema migrans rash. Meanwhile, current tests, which measure Lyme disease indirectly through the antibodies a person’s body creates to fight the disease, tend to perform poorly in the early weeks of an infection because it takes time for antibody production to rise to detectable levels. By some estimates, traditional serology-based test methods identify fewer than 40% of patients with early disease.

Kalorama estimates and forecasts Lyme Disease testing markets in our latest worldwide IVD market study.

For Lyme disease, the most common tick-borne disease in the United States, the CDC has recommended the same testing process since 1995: a serology-based two-tiered algorithm. The first tier is an immunoassay, then if the immunoassay results are positive or equivocal, it is followed by the second tier, a Western blot. To address the issue of false negatives for early-stage infections, the CDC suggests a provider consider treatment based on clinical presentation alone if the patient has had symptoms for less than 30 days, and offer a repeat immunoassay a few weeks later to confirm the diagnosis.

Serology has remained the only technique employed by all of the FDA-approved Lyme disease tests, according to a 2016 review in the Journal of Clinical Microbiology (DOI: 10.1128/JCM.03394-15), even while molecular and “-omics” methods have transformed other realms of clinical microbiology diagnostics.

Enzyme-linked immunosorbent assays (ELISA), which are typically used as the first step in the two-tier algorithm, have improved over the years, with targets that are more specific to Borreliaburgdorferi and less likely to cross react with other infectious agents. Yet their performance is still best when they are paired with Western blots, and Western blot testing has many limitations, including low sensitivity for early stage infections and a labor-intensive, somewhat subjective process.

Some researchers are now advocating for new testing algorithms, in particular a two-ELISA algorithm, where an initial positive or equivocal ELISA result is followed by a second ELISA assay that has slightly different targets. They find this method effective and also 27.1% to 44.0% cheaper than the two-tier algorithm with Western blot. A 2018 study comparing three variations of immunoassay-only algorithms found them all accurate, and in some cases even better than the traditional two-tier algorithm. However, the CDC still recommends the traditional two-tier algorithm.

For the other tick-borne diseases, the diagnostic options are limited. Immunofluorescent assays are available for BabesiaAnaplasmaEhrlichia and Rickettsia, although accuracy varies by laboratory. Some tick-borne viruses can be detected by specialty labs. For other tick-borne diseases, such as Southern tick-associated rash illness (STARI), there are no immunoassays available. There are no commercially available tests that simultaneously detect multiple tick-borne disease agents.

New tests on the horizon

That explains why the TBD Serochip has gotten so much attention this year and piqued the interest of the public. U.S. National Institutes of Health director Francis Collins even highlighted the February TBD Serochip study in a blog post in June, noting that it was developed by NIH-funded researchers.  The TBD Serochip is a serological test, like the commercially available tests today. However, it detects multiple targets based on a variety of newly identified antigenic proteins, so it has the potential to be more specific to Borrelia than other than previous tests. Also, it can detect antibodies to multiple tick-borne pathogens simultaneously. The first version of the TBD Serochip can detect Lyme disease, babesiosis, and anaplasmosis, as well as human monocytic ehrlichiosis, Rocky Mountain spotted fever, Heartland virus, and Powasan virus. New pathogens can be added to the assay as new targets are discovered, in a process that the researchers say would take only about 4 weeks.

The lead author of the TBD Serochip journal article, Rafal Tokarz, PhD, told Infectious Disease Advisor in March 2018 that the challenge now is to improve the test and make a simpler version that can be used by clinical laboratories.

“Although our test works quite well, we are still validating it and are trying to make it even more comprehensive by including additional agents that we did not include in the first version of the test,” Tokarz said.

Tokarz told Clinical Laboratory News in July 2018 that the TBD Serochip in its current form would still be useable by specialty labs only, but the goal is to make it a point of care test. He predicted the test would be available for clinical use within the next two years.

The TBD Serochip is just one possible approach to better tick-borne disease testing.

Researchers at the CDC and elsewhere are working to develop tests for tick-borne diseases based on metabolomics, which is the technique of finding a unique signature of metabolites in a person’s blood that corresponds with a certain disease.

A promising proof-of-concept study was published in 2015 showing that liquid chromatography-mass spectrometry could be used to detect a biosignature of 44 “molecular features” that correctly classify early Lyme disease patients versus healthy controls. A follow-up study in 2017 showed that the same technique could distinguish between early Lyme disease and STARI, which is a tick-borne illness that causes a rash similar to Lyme disease. There is currently no diagnostic blood test for STARI because the causative agent is unknown.

Meanwhile, other researcher groups are searching for molecular diagnostic techniques to identify tick-borne diseases. A non-for profit organization called Translational Genomics Research Institute (TGen) announced in 2017 it had raised hundreds of thousands of dollars from patient advocacy groups to develop LymeSeq, a DNA-based test to detect “multiple strains of Lyme bacteria.” Their goal, as of 2016, was to use next generation DNA amplicon sequencing to detect “over 22 strains of Lyme bacteria, all major co-infections and non-Lyme causes of disease like influenza or staph in a single blood test.”

Some reference laboratories already offer polymerase chain reaction (PCR) blood tests for Lyme disease, but with the caveat that they may be used as an aid to diagnosis but are not diagnostic alone. In general, direct detection of the spirochete bacteria that cause Lyme disease bacteria has not worked clinically because there are so few bacterial cells in the body. As a result, the sensitivity of PCR to B. burgdorferi DNA in blood, plasma, or serum samples from patients with Lyme disease is low.

While academic researchers pursue these new directions, in vitro diagnostics developers appear to be focusing on improving on serology-based tests that are already available, making them faster and easier to use.

For example, Quidel announced in August 2018 that its Sofia 2 Lyme fluorescent immunoassay received FDA 510(k) clearance and a CLIA waiver. The assay, which runs on the 2-pound benchtop Sofia 2 Fluorescent Immunoassay Analyzer, requires only a fingerstick whole blood sample. It detects IgM and IgG antibodies to Borrelia burgdorferi, returning a result in 3 to 15 minutes. With its new CLIA waiver, the assay can now be used in physician offices or clinics.

The current developments, product launches and company plans in IVD testing on smartphone platforms has been detailed by Kalorama Information in a recent report by Kalorama’s Rob Camp: https://www.kaloramainformation.com/Smartphone-Based-IVD-Products-Trends-Potential-12019398/

We summarize some of the findings of our study here.  This represents a fraction of the findings of the report:

The techniques that can most successfully harness mobile phone technology look to be lateral flow immunoassay-based tests, ELISAs, and spectrophotometry, as they are methodologies that use a tool that has become ubiquitous in the developed world and is on the rise globally, the smartphone camera. In recent years, researchers have been developing algorithms and machine learning systems that can scan and analyze colorimetric tests as accurately as a sophisticated piece of laboratory machinery, but at a fraction of the cost. While the technology appears yet to be in its nascent stages, there are quite a few examples of devices under development that employ these techniques

According to the GSM Association, two-thirds of the world’s population have a mobile phone service plan, but growth is slowing as the market matures; it took four years to go from 4 to 5 billion subscribers. It is projected to take even longer to reach another billion; estimates are 5.7 billion unique subscribers by 2020, representing 72% total market penetration. However, the number of subscriptions per person is widely distributed. On average, there are 1.04 subscriptions for every person worldwide, ranging from only 0.08 per capita in Eritrea to nearly 2.5 in Hong Kong and over three in nearby Macau. The table below highlights the growth of mobile services in twenty-four selected countries, and the map illustrates the overall global distribution of subscriptions in 2017.

Formed out of the University of Colorado-Boulder, Mobile Assay is a startup that produces a smartphone-compatible lateral flow assay reader that is stated to be able to read test strips of any type; the mReader imaging system transforms qualitative tests into highly sensitive quantitative tests. The company’s universal Lab-on Mobile-Device (LMD) platform uses Mobile Image Radiometry (MIR), an image analysis algorithm that converts the analog visual signals of a rapid diagnostic test into a normalized and calibrated digital signal.

The platform improves the quantification of RDTs by increasing sensitivity over a hundredfold, comparable to ELISA. Mobile Assay has partnered with companies like Alere/Abbott and Rapid Medical Diagnostics to validate a number of tests for their platform, focusing primarily on insect-borne tropical diseases, including lymphatic filariasis, malaria, onchocerciasis, and schistosomiasis.

Novarum (Cardiff, Wales, UK) develops smartphone-based mobile POCT platforms customized to users’ specifications and made to work for any number of applications. Users work with Novarum to develop an app designed for specific testing needs; the app is then used to scan a code to identify the type of test to be conducted, then to scan the test results. Results can be sent to a database of the user’s choosing via email, SMS, web, Bluetooth, or USB.

iXensor’s Eveline ovulation test also uses a dipstick test, but is instead a single-use LH-detecting colorimetric test unit that attaches to a clip set over the front camera of a
smartphone. The included app uses iXensor’s adaptive algorithm to present data in a three-tiered snapshot of the user’s fertility, and stores the information in a Fertility Calendar that gives the dates the user will likely be at her most fertile. Reminders can be set to take tests to more accurately pinpoint peak fertility.

Fertility Tech (Las Vegas, NV) takes a different approach to ovulation testing: the company’s Ovatel is a saliva-based test that functions more as a microscope than a lateral flow assay analyzer. Users place a saliva sample on a lens that attaches to the smartphone camera, which analyzes the image for a certain fern-like physical pattern, formed by salt crystals, that appears in the sample due to spikes in a woman’s estrogen levels during her cycle. No basal body temperature measures or urine samples are necessary, nor are additional purchases, as Ovatel is reusable.

BACtrack released the BACtrack Mobile Smartphone Breathalyzer in April 2013. The device uses Xtend Fuel Cell Sensor technology offered in their professional-grade
analyzers, which detect the electrochemical process that oxidizes the alcohol in a breath sample and produces an electrical current, which is then relayed back to the analyzer’s sensor to determine the user’s BAC; the device also features a mini solenoid pump to ensure the most accurate and efficient breath capture for testing.

The BACtrack Mobile breathalyzer is compatible with most Apple devices running iOS 8.0 or newer, including iPod Touch, as well as most Android smartphones by Samsung and Google. The device connects wirelessly to the phone via Bluetooth and operates through the BACtrack Companion App, which features the company’s ZeroLine technology, which estimates when the user’s BAC will return to 0.00%. The app also helps the user to call a ride sharing service when necessary.

For more information on smartphone IVD combinations, Kalorama’s recent report is available here: https://www.kaloramainformation.com/Smartphone-Based-IVD-Products-Trends-Potential-12019398/

We at Kalorama Information have just released the Eleventh Edition of our flagship publication,The Worldwide Market for  In Vitro   Diagnostics. This report has been updated for two decades, keeping readers informed about developments in all areas of the IVD industry, around the world, in one volume. At 1,800 pages, the report provides market size estimates and projections for the entirety of the clinical diagnostics testing market. It also profiles hundreds of competitors, notes significant acquisitions and other deals, discusses trends and breaks out regional and country markets. The latest edition provides market size and forecasts to 2023 for defined segments of the IVD market and various sub-segments.

The Centers for Medicare and Medicaid Services (CMS) introduced revised payments, effective January 1, 2018, for clinical diagnostic laboratory tests based on median values that will be reported during 2016 and 2017. All laboratories that have more than $12,500 in Medicare revenues from lab services and who receive more than 50% of their Medicare revenues from laboratory and physician services during a data collection period are required to report both private payor rates and volume data. Payments for lab services through Medicare are maintained in the Clinical Laboratory Fee Schedule (CLFS), and the Physician Fee Schedule (PFS).

Companies are expecting a reduction in payments due to the upcoming changes but the results and how they affect each company will vary. For the three year period after the prices are established a test price cannot be reduced by more than 10% per year and for 2021-’23, a test price cannot be reduced by more than 15% per year.

According to CMS, approximately 55% of independent laboratories and about 95% of physician office laboratories will be excluded from reporting private payor data but the remaining laboratories reporting account for 99% of CLFS lab spending and 92% of physician lab spending. The regulation allows for civil monetary penalties of up to $10,000 per day for failure to report or for reporting fees incorrectly.

Signed into law in 2014, PAMA establishes a market-based pricing system for lab tests where Medicare payment for a test equals the weighted median of private payor rates. In implementing a process for collecting the information needed to establish pricing, CMS said only “applicable labs” could report test payment rates and volumes from private payors.

PAMA is intended to introduce a more organic methodology to reimbursement adjustments for lab testing under Medicare and will replace uniform cuts implemented across the Clinical Laboratory Fee Schedule (CLFS) with the Affordable Care Act (ACA) and other past legislation. The recent CMS final rule delays implementation of market-based pricing to 2018 and expands the body of reporting labs in order to make prices more reflective of the entire lab market. The law has the potential to significantly cut Medicare reimbursement prices on routinely performed, highly automated tests – sparking further consolidation in the clinical lab services market – and increase IVD industry emphasis upon the development of new biomarkers and sophisticated and esoteric assays. In a blog post on its website, Kalorama Information expects the new law to hit smaller labs the hardest.

ACLA files suit

CMS sought public comments on its draft payment rates until late October 2017, intending to publish final rates in November. The segment of the lab community that largely fared well in the PAMA pricing process, makers of single-source, multianalyte algorithm-based assays, or ADLTs, supported the timeline.Over 6,000 comments were submitted, with many asking the agency to delay PAMA implementation and reevaluate the data collection process; in December 2017, the American Clinical Laboratory Association did just that. ACLA filed a request for an injunction against HHS to delay PAMA implementation and for CMS’s data collection process to be reevaluated. ACLA argued that CMs instituted a flawed data reporting process that excluded the majority of laboratories from reporting private payor data. To wit, 90% of CMS’s data came from independent laboratories, while 7.5% came from physician office labs; only 21 out of seven thousand hospitals reported payor information, representing just one percent of the data collected, while they accounted for nearly a quarter of the Medicare payments made under the Clinical Laboratory Fee Schedule.

CMS performed a simulation to gauge whether including more independent, physician office, and hospital labs would have significantly impacted rates, and concluded that it wouldn’t have made much difference. According to CMS, based on information collected from applicable labs, payment for lab tests would decrease by 21.9 percent in 2018, compared to the national limitation amount it paid for lab tests during 2017. According to the simulations it performed, allowing more labs to report would have decreased payments by around 20 percent.

According to the lawsuit, most of the data was collected from two companies: Quest Laboratories and Laboratory Corporation of America, whose lab facilities are primarily located in urban areas and have lower cost structures. However, both companies have issued statements in support of the lawsuit, agreeing that the data collection method employed by CMS was indeed flawed.“Hospitals and physician office labs comprise half of Medicare clinical lab fee schedule volume and lab spending, but only accounted for 8.5 percent of the reported lab volume used by CMS to calculate the rates,” said Quest CEO Steve Rusckowski. “The new PAMA rates published by CMS do not reflect the intent of Congress when it directed CMS to implement market-based Medicare rates for lab testing,” said David P. King, chairman and CEO of LabCorp. “We join with the American Clinical Laboratory Association (ACLA) and others in our industry in calling on Congress to take swift action to prevent the harm that will occur if these rates take effect.”

Winners and losers

Not all the news was bad. PAMA created a new category of assays, called advanced diagnostic laboratory tests (ADLTs), which CMS has defined as tests developed and offered by a single lab that use a unique algorithm to analyze multiple DNA, RNA, or protein markers, and which provide new clinical diagnostic information that can’t be obtained by any other test. Each test will be identified by codes unique to them, but the ADLT definition is controversial among industry players. Test developers are awaiting further clarification from CMS regarding the requirement that ADLTs must provide new clinical diagnostic information.These tests will be paid full list price for three quarters after their introduction, then payment will be based on weighted median private payor rates like all other tests are.In this category, Veracyte’s Afirma Gene Expression Classifier, for distinguishing which thyroid nodules are benign and which are suspicious of cancer, had a price increase from $3,222 to $3,600, while CareDx’s AlloMap test for gauging cardiac transplant rejection risk increased from $2,841 to $3,240.

Other winners— or “less less-fortunate”—include Myriad Genetics, as its myRisk Hereditary Cancer test received an initial price of $2,949, up from $2,781 in 2017, and the company’s Vectra DA rheumatoid arthritis test also saw a pricing bump to $841, compared to $591. However, CMS’ proposed pricing could be 10 percent lower for Invitae’s hereditary cancer panel, which is currently being paid at $931 and got a 2018 PAMA price of $838. Exact Sciences’ Cologuard saw a slight dip from $512 to $509. Illumina and Natera’s Noninvasive prenatal testing is currently paid at $802 and its proposed reimbursement was reduced to $759.

Genetic sequencing procedures (GSPs) designated for diseases affecting the Ashkenazi Jewish community shot up from $602 this year to $2,449.However, there appears to be no relation between reimbursement and the cost of GSPs, as a panel for Lynch syndrome fell from $802 to $722. Genomic Health’s Oncotype DX breast cancer recurrence test, previously paid at $3,443, has increased to $3,873; the company’s Oncotype Colon Cancer test saw a miniscule reduction from $3,126 to $3,116. Pricing for next-generation sequencing panels of 50 genes or less got a tiny bump from $598 to $602; panels of greater than 50 genes, being listed for the first time, get $2,920.

Infectious disease testing took a huge hit, from antibody assays to nucleic acid amplification tests, for a whole host of targets, with rate reductions in the 30-35% range. Multiplex respiratory syncytial virus DNA testing saw a range of cuts, going deeper with the number of pathogens being detected—now a test that detects 12-25 targets only rates $11.10 more in reimbursement than one that targets 6-11, eliminating any economic advantage of greater multiplexing. Rates for immunoglobulin M antibody tests forChlamydia trachomatisdrop nearly 39%, while a NAAT for the pathogen falls just over 35%. An HIV-1 quantification and reverse transcription test loses 36.35% of its reimbursement value, while a simpler antibody test falls by “only” 30.22%. Generic DNA amplification tests fell over 37%, and hit particularly hard areTrichomonas vaginalisandStreptococcusA NAATs, rates for both reduced by well over 40%.

Other problems impeded fair pricing. There were some chasmic ranges in pricing for some non sole-sourced procedures; for example, the median price for BRCA genetic testing was reported to be $2,395, but the high end of the spectrum showed payments of up to $30,000. CMS had to use gapfill and crosswalk methods to post preliminary pricing for 58 CPT codes for which the agency had received no reports; CMS treated some of these procedures, some of which were not well enough understood for their pricing determination, like existing procedures the agency perceived to be in some way similar. CMS is proposing to remove some of these from the CLFS, but there is no provision in PAMA to do so.

For the source of these rate changes and more, see  CMS’s page on 2018 PAMA regulations.

AACC’s opinion

According to AACC, clinical labs are going to be suffering cuts of up to 30% over the next three years; the most efficient, financially healthy, and strategically diversified labs will be the ones to survive, and smaller labs will be feeling the most pain. Among them are those that serve nursing homes and those that receive most of their testing payments from Medicare and Medicaid, and they are not likely to survive. For example, Aculabs, a laboratory testing company that tests for over 300 nursing and assisted living facilities, will lose 30% of its revenue over the next three years; elderly patients will have to be moved to more costly hospitals for their testing.

While laboratories that offer proprietary testing will fare better—Genomic Health’s Oncotype DX Breast Cancer test will be reimbursed $3,873 and CareDX’s AlloMap test will get $3,240—private payors will not be willing to pay such prices, and this will diminish over time. Overall, results are mixed; the outlook varies for physician office labs, as rates for some tests like HbA1c and specimen cultures will get a boost over the coming three years, while they will fall for others, like complete blood counts. To compensate, labs may perform customized test profiles that Medicare will pay on an individual test basis, as it had announced it would do beginning on the first of January. Hospital outreach labs will not fare so well with the coming cuts, and many health systems have already sold their labs to Quest or LabCorp last year.

Whether ACLA’s lawsuit changes outcomes or not, AACC asserts that laboratories will have to become more streamlined in order to survive. Many are already consolidating, reducing test costs through economies of scale, and they may also form networks to gain leverage by negotiating contracts as larger entities. Outsourcing billing to a commercial vendor can also save money, costing as little as half of in-house billing. Automation increases efficiency and reduces costs, not only through increasing speed and throughput, but also by reducing errors and the use of manual labor.

In many ways, the IVD market of today does not resemble the market five years ago.  2018 appears to be the year where a number of trends that had been discussed began to gel.  With that in mind, Kalorama Information will be on hand for UBM’s BIOMedDevice Convention in San Jose, CA next month.   In vitro diagnostics represents a 65 billion-dollar market, according to Kalorama Information’s latest report on the worldwide diagnostic industry.  That makes it a large, competitive and growing market.  But the significance of in vitro diagnostics goes beyond the market numbers.  IVD really is significant because of its reach: testing reaches touches clinical lab services, hospital care provision, pharmaceuticals. These add up to a multi-trillion dollar “Influence Market” for IVD.

Among many trends that Kalorama will discuss at the meeting:

  • Direct-to-consumer testing was a scattered array of projects and small startups prior to 2018.  Now, it is a real factor in the business.  With both Lab Corp and Quest making direct to patient pitches, and 23 and Me’s FDA approval for its consumer-ordered BRCA test, there is an actual market for these products.
  • There are nearly 10,000 locations where a patient now can walk in and secure a healthcare visit with no appointment.
  • Novel biomarkers are being discovered.  The track record of PCT in sepsis treatment and and high-sensitivity troponin markers in detecting heart attacks has been evident from their migration on to large analyzer systems.  This year saw developments in tests for traumatic brain injury and Alzheimer’s Disease, including two FDA approvals for microRNA biomarkers for the latter disease.
  • Sequencing: Clinical systems were introduced and smaller footprint instruments have been developed.  Simplified (NGS in a Box) systems have made gains.   How sequencing will fit into clinical diagnostics is still being determined, but it is clear it will have some impact.

There are many factors causing an increase in the rise of diagnostic services to monitor health, which in turn is stoking the growth of the IVD market. Trends such as technological advancements, rising end-user awareness, and miniaturization is driving the demand for point-of-care products and have increased the access to diagnostic tests near patient site. But with growth comes new regulations and implementation dates put forth for medical device manufacturers active in Europe. Compliance deadlines for 2020 and 2022 are looming.

With this in mind, Kalorama announces that Publisher Bruce Carlson will speak at the BIOMedDevice convention in San Jose, CA, December 4-6th, 2018.  The keynote speech:

The IVD Market Opportunity: Fast-Growth Markets, New Products, Disruptive Trends ( https://bmsj18.mapyourshow.com/7_0/sessions/session-details.cfm?ScheduleID=11 ) will be held on December 5th.

Topics covered include:

  • Retail clinics, Direct-to-Consumer marketing, accelerated aging and trends driving new product development in the IVD space
  • Point-of-Care, digital capillary testing, wearable, and other products moving IVD diagnostics forward
  • Medicare Part B Cuts and New FDA Proposals
  • New European IVDR affecting 80% of IVD products – what you need to know
  • Market Statistics for In Vitro Diagnostics and Contract Manufacturing for In Vitro Diagnostics