Kalorama Information’s publishing partner LabPulse.com recently started.  Using Kalorama Information’s data sources and an editorial team dedicated to breaking news.  The website provides a unique perspective on CLIA lab and IVD product developments.

The site provides a forum for pathologists, laboratorians, business managers, researchers, members of organized medicine, and industry to interact and learn about topics within the clinical laboratory field with the ease and speed that only the internet can provide.   Staff members include executives, editors, and software engineers with years of experience in the healthcare publishing industry.

LabPulse is part of Science and Medicine Group. We operate a family of websites providing targeted content for healthcare markets:

Science and Medicine Group is a leading research, publishing, and advisory firm serving the life science, analytical instrument, diagnostic, medical imaging, and dental industries.

By Emily Hayes, LabPulse.com editor in chief
FROM Kalorama’s partner publication Lab Pulse.com 

Testing for the tau protein in blood could help predict the outlook for the rare and deadly Creutzfeldt-Jakob disease (CJD), a discovery that also has implications for research in Alzheimer’s disease and other neurodegenerative disorders, researchers reported in JAMA Neurology on May 6.

Tau is a protein associated with neuronal damage, and previous research has found elevated tau levels in patients with CJD. But tau levels are typically obtained through cerebrospinal fluid (CSF), acquired via lumbar puncture — an invasive procedure. What if tau could be measured through blood samples instead?

Blood testing of total tau (t-tau) was found to be a unique predictor of survival in patients with sporadic CJD (sCJD), and it is more convenient than other methods for estimating a patient’s prognosis, reported a team led by Adam Staffaroni, PhD, a neuropsychologist at the University of California, San Francisco (UCSF) Memory and Aging Center.

“These findings further bolster the value of blood-based biomarkers based on their minimally invasive and relatively inexpensive nature and build on prior studies that suggested patients with sCJD and controls can be discriminated with relatively high accuracy using blood-based assays,” the group wrote.

The results promise to improve clinical care and help ensure that clinical trials in neurodegenerative diseases are adequately powered, according to the researchers. However, the findings still need to be validated in larger studies before they can be put into practice.

Getting a handle on a grim diagnosis

CJD belongs to a family of human and animal prion (abnormal forms of cellular proteins) diseases. Like Alzheimer’s and Huntington’s disease, it causes psychiatric symptoms and decline, but it does so much more quickly.

According to the U.S. National Institutes of Health (NIH), only 350 cases of CJD are reported annually; on average, CJD occurs at about age 60, and individuals with the disease rarely live past a year. The sporadic type of CJD is the most common, accounting for 85% of cases. CJD is typically diagnosed through electroencephalography, CSF diagnostics, and MRI, with confirmation in autopsy after death.

Baseline total tau on CSF tests and a polymorphism at the codon 129 genotype are currently used to help predict how long patients will live, but there has been interest and some research published about the potential for blood testing as a noninvasive biomarker for CJD and other neurological disorders, Staffaroni and colleagues noted.

In the current study, the researchers sought to determine the utility of plasma and CSF biomarkers compared with other characteristics of CJD by evaluating patients referred to the UCSF Memory and Aging Center with probable or pathology-proven disease between 2004 and 2018. On average, CJD patients live for four months, but lifespan is highly variable, with some surviving for weeks and others for years, the authors noted.

“Accurate prediction of disease duration has implications for clinical management, helping patients and families prepare for the disease course,” they wrote. “Accurate prediction of survival time also affects clinical trial design, as stratifying patients based on expected disease course can improve a trial’s power, thereby reducing costs and ultimately maximizing the number of trials that can be funded. This is especially germane in sCJD, given the rarity of the disease and variable survival time.”

In addition to blood and CSF tests, the researchers assessed five other factors associated with survival:

  • Sex
  • Age
  • Genotyping of the prion protein gene at codon 129
  • The Barthel index, a measure of ability to carry out daily life activities
  • The Medical Research Council (MRC) prion disease rating scale, which assesses cognitive function as well as life activities

Of these five factors, three — codon 129 genotyping and scores on the Barthel index and the Medical Research Council scale — significantly correlated with the length of survival, with lower levels of function predicting a faster disease course, Staffaroni and colleagues reported.

The plasma total tau level and the Barthel index each had independent value for predicting length of life, a statistically significant finding, they wrote. And as with plasma biomarkers, the CSF t-tau level remained associated with survival after controlling for the Barthel index and codon 129 genotype, the researchers noted.

“The correlation between CSF and plasma t-tau level, together with the concordance of CSF and plasma t-tau level in predicting survival time, further strengthens our finding that plasma tau level may be a useful biomarker in this cohort,” they wrote.

Building the evidence base for plasma tau

The UCSF investigators wrote that the data are in line with prior research, in that plasma t-tau correlated with the rate of disease progression, matching a study of 45 patients by Thompson et al (Journal of Neurology, Neurosurgery & Psychiatry, September 2018, Vol. 89:9, pp. 955-961). Plasma t-tau did not correlate with survival in that study, they noted, but Thompson and colleagues had not controlled for baseline functional severity.

In the UCSF study, the plasma t-tau level did correlate with survival regardless of functional severity at baseline. Furthermore, the researchers found that the level of plasma neurofilament light (NfL), the level of CSF t-tau, the ratio of t-tau to phosphorylated tau, and the level of neuron-specific enolase (NSE) were also significantly associated with the length of survival, but less so than plasma t-tau.

“Importantly, when baseline functional status and plasma t-tau levels were modeled together, both were strong, independent predictors of survival time,” the group wrote. “This suggests that clinical measures and plasma t-tau level could be combined to further improve prediction accuracy.”

What this means for Alzheimer’s

The results still need to be validated in a larger cohort, and assays are currently only available for research use, though commercial tests are in development. Elevated plasma t-tau is found in patients with many other conditions, including the neurodegenerative diseases Alzheimer’s and frontotemporal dementia, as well as acute brain injuries. However, its value as a biomarker has been questioned in other diseases like Alzheimer’s partly because the plasma t-tau levels did not match the CSF t-tau levels, Staffaroni and colleagues wrote.

“One explanation for the high correlation between CSF and plasma tau level in sCJD is that the rapidity and amount of neurodegeneration may result in continuous, high quantities of tau in the periphery that overcome the peripheral mechanisms of elimination,” the researchers wrote. “Others have argued that higher plasma t-tau concentrations in sCJD may be driven by preterminal cases having higher t-tau levels.”

CJD is an excellent model for treatments targeting the prion-like pathogenesis of neurodegeneration, Staffaroni et al wrote, adding that “rapid decline in prion disease may allow clinical trials to detect a drug effect more quickly than trials enrolling patients with slowly progressing conditions.”

“This study adds to research in other dementia disorders, such as Alzheimer disease, suggesting that blood-based assays may revolutionize the way that neurodegenerative diseases are diagnosed and monitored,” they wrote.

As with Alzheimer’s, the field needs to standardize methods for testing, optimize cutoff points, and replicate the research before moving these biomarkers into the clinic or using them in clinical trials, the authors advised.

 

As detailed in a recent Linked In article (https://www.linkedin.com/pulse/yes-issues-emrs-paper-medical-records-coming-back-anytime-carlson/), articles that criticize the EHR tend to avoid a historical comparison to the days of paper-based records, and that’s partially because it’s hard to document those errors. EHRs in an odd way provide their own spotlight on their failures, whereas paper record errors would require extensive manual review to find — the very type of work EHRs sought to replace.

And there’s a failure to recognize that some of the problems with EMR – such as excessive drop downs – came as a result of fixing medical errors with paper records, where information could simply be left out.

Despite the criticism, sales of EMR continue to grow, as they have every year since 2007, when we first began market reporting on the technology.  We estimate the market reached $31.5 billion in 2018 and continues to grow, according to our latest study ” EMR 2019: The Market for Electronic Medical Records,”

EMRs are under attack these days – portrayed as time wasters, stress causers, and even according to one major media account, killers. Yet some of those criticisms seem to conveniently forget the paper records they replaced and their own problems.   In this article, we look at the EMR market, the criticism of EMRs and the past criticisms of paper records.   

Read the Article Here: https://www.linkedin.com/pulse/yes-issues-emrs-paper-medical-records-coming-back-anytime-carlson/

 

This article is based on information  from Kalorama’s partner publication IMV (http://www.imvinfo.com), a premier source of information for the radiology industry. 
In the 1980s, CT and MR scanners revolutionized the imaging industry by generating images digitally rather than using analog/film-based technology.  Since then, radiology/imaging departments have progressed to being almost fully digitally based, with the large installed base of general radiography units being the last frontier.  Due to the need for relatively large imaging plates to image large body parts in a single view, such as the chest, the image quality of the digital technology had to be perfected by industry and proven to the radiology community.
For general x-ray, the adoption of digital technology has gone through several transitions.  Initially, the most cost effective way to effect the transition was to use computed radiography (CR) technology, where the x-ray image is acquired digitally onto a phosphor plate that is installed in a cassette similar in size to the film cassette.  Once exposed, the CR cassette is physically taken to a CR reader to capture the x-ray image digitally.  With the development of digital radiography (DR) technology, the digital x-ray images are acquired directly into a computer, thereby speeding up the acquisition and processing time for the x-ray images.
As of 2010, just over one quarter of the fixed general x-ray systems installed in U.S. hospitals had DR technology, while 70% were CR-only systems and 4% were still film-based.  With the passing of the Consolidated Appropriations Act of 2016, x-ray imaging providers received an extra push to continue the transition to DR technology, with penalties for non-compliance starting in 2017/18.   IMV has been monitoring this adoption trend over the last decade, and IMV’s 2019 X-ray/DR/CR Market Outlook Report observes that over 80% of the fixed general x-ray installed base in U.S. hospitals uses DR technology, up from half of the installed base in 2015.

 

“IMV’s 2019 X-ray/DR/CR Market Outlook Report observes that over 80% of the fixed general x-ray installed base in U.S. hospitals uses DR technology, up from half of the installed base in 2015.”

 

Going forward, IMV anticipates that over the next three years, about three quarters of the remaining CR-only systems currently installed are being planned for replacement with new DR systems or to be retrofitted using DR detector kits.  Some hospitals, such as Critical Access hospitals are exempt from the CMS payment reduction policies, so they may be slower to transition, but a number of these hospitals are still planning to replace their CR technology with DR to benefit from the increased productivity of DR technology.
General radiography is continuing to play a major role as a “primary care” imaging modality in U.S. hospitals, utilized for inpatients, outpatients, and emergency patients.  The top five x-ray procedure types performed are chest, abdomen/pelvis, extremities, and spine studies, and constitute almost 90% of the procedure volume.  At hospitals, fixed and mobile/portable x-ray systems are located, not only in the main radiology department, but also in other departments on hospital campuses and in outpatient clinics, imaging centers, and urgent care centers managed by radiology in the hospitals’ service areas.  As a result, even though CT, MRI, PET, and Nuclear Medicine (NM) technology have higher visibility as the “high tech” imaging modalities, the number of imaging procedures performed on fixed general x-ray systems and mobile/portable x-ray units by U.S. hospitals and their associated locations far exceeds the combined volume of procedures performed on their CT, MRI, PET, and NM imaging systems.  IMV estimates that U.S. hospitals performed a total of 152.8 million procedures on fixed general x-ray systems in 2018, compared to 114.9 million procedures performed using their CT, MR, PET, and NM systems, thereby comprising 57% of the 5-modality total of 267.7 million imaging procedures performed by U.S. hospitals (not including procedures performed in independent imaging centers and office practices).
The IMV X-Ray Market Outlook, from Kalorama’s partner publisher, can be found at:   https://imvinfo.com/product/2019-x-ray-dr-cr-market-outlook-report/
 
Moreover, IMV estimates that 61.4 million procedures were performed using mobile/portable general x-ray units by U.S. hospitals, bringing the total number of general x-ray procedures performed in 2018 to an estimated 214.2 million, which accordingly comprises 65% of the 5-modality total in U.S. hospitals and their associated locations.

Now that general radiography has joined the ranks of the digital modalities, future artificial intelligence (AI) and machine learning applications that harness the power of the digital information will be a key factor in facilitating further clinical and workflow improvements for radiology.  While the adoption of AI applications for clinical decision support using general x-ray data is still in its early stages, radiology administrators see great promise for using such tools to improve image quality output, workflow, and to use as clinical decision support for radiologists.

IMV’s 2019 X-ray/DR/CR Market Outlook Report explores trends in U.S. hospital radiology departments for the adoption rate of CR-to-DR technology, x-ray procedure volume, the installed base of fixed and mobile general x-ray DR vs. CR systems, x-ray replacement cycles, purchase plans for DR retrofits and fixed & mobile x-ray systems, manufacturer installed base share and brand loyalty, and site operations characteristics. Respondent opinions on how key issues are affecting their department priorities and outlook are featured, and the report provides 5-year market forecast scenarios addressing the fixed general x-ray unit market.  X-ray manufacturers covered in this report include Agfa, Canon, Carestream, Del Medical, Fujifilm, GE, Konica Minolta, Philips, Samsung, Shimadzu, and Siemens, who provide fixed, mobile/portable general x-ray systems, and/or DR retrofit kits.
The report is based on survey responses to an online survey conducted by IMV in January 2019 with 340 radiology administrators/managers in U.S. short-term general hospitals.  Their responses have been projected to the IMV-identified universe of over 5,300 hospitals in the United States that have at least one fixed general x-ray system installed.  For information about purchasing IMV’s report, visit the corporate website at http://www.imvinfo.com or call 703-778-3080 to speak with a representative.

 

LORNA YOUNG is the Senior Director of  Market Research for IMV.  The IMV X-Ray Market Outlook can be found at:   https://imvinfo.com/product/2019-x-ray-dr-cr-market-outlook-report/

Results below expectations, perhaps explained by one-time events, were coupled with new product launches and some silver lining in niche markets, as the top two IVD companies announced first-quarter results.  Roche’s Diagnostics division reported sales of $2.9 BN CHF (approx. $2.86 BN USD) and 1% growth, with Molecular Diagnostics as main contributor.  That was flat growth since last year the division grew 5% in the first quarter.

Roche is the world’s largest diagnostic company and its results can speak to the broader market.

The company claimed temporary events and one-time offsets dampened growth, and there were some unusual events in the quarter.  Distributor inventory reduction on point-of-care products in China and one time offsets in tissue diagnostics, also free-of-charge deliveries following the recall of CoaguChek test strips in the fourth quarter.

Within these results, a few events are notable for watchers of diagnostic markets:

  • Roche reported that its molecular Point of Care Sales Up 18%, as cobas Liat finds markets in physician offices and decentralized hospital testing locations.
  • Sales in cervical cancer diagnosis grew 52 percent and sales in blood screening grew 14 percent.
  • While Diabetes care grew 1%, growth was 18% in North America due to recent management care contract wins.
  • While sales in Japan and China were disappointing, EMEA sales were up 3% and Latin America was up 8%.

The company noted several product launches.   The Cobas VivoDx system for antibiotic resistance testing provides results in under 6 hours and can perform 96 tests per 8-hour shift.  NAVIFY mutation profiler combined with NAVIFY therapy matcher both [ph] as a curated knowledge base of genetic fragments to help interpret the clinical significance of the patients and identify suitable therapies. and the VENTANA PD-L1, SP142 Assay, the first FDA companion diagnostic approval for use in first line triple negative breast cancer or TNBC.

Kalorama Information’s Worldwide Market for In Vitro Diagnostic Tests provides market sizing and forecasting for all categories of the IVD market
Now in 11 Editions. 

Abbot Diagnostics grew .2% on a reported basis to $1.8 BN dollars, though currency effects clouded otherwise 4.4% organic growth.    Growth was driven by long-term double-digit growth in its Alinity molecular diagnostic platform and other products.  But due to lower flu test revenues , rapid diagnostic revenues, comprising Alere, which Abbott bought in late 2017, decreased 4 percent to $537 million from $559 million.

New products included a CE Mark for Abbott’s Determine HBsAg2 rapid diagnostic assay. highly sensitive, easy-to-use, rapid lateral flow test enables identification of those with.  And the company received a CLIA waiver for their BinaxNOW Influenza A & B Card 2 assay.

 

 

A relatively new disease with particular strength in the New York City area but also in 12 U.S. states has seen 617 cases as of time of writing – with particular strength in weakened patients and those in long-term facilities.  Because the fungus is detectable only with complex lab tests such as mass spectrometry, sequencing and novel PCR, test makers once again have an opportunity to demonstrate products can handle novel pathogen threats.

The fungus — Candida auris, also referred to as C. auris —  is treatable with antifungal drugs called echinocandins. However, some C. auris infections are resistant to the main types of medications.   It is particularly found in hospitals and long-term care facilities.   The most common symptoms of invasive Candida infection are fever and chills that don’t improve after antibiotic treatment for a suspected bacterial infection.  While healthy people do not often get the fungus, the CDC is warning all in such facilities to be vigilant about washing hands after patient contact.

The fungal infection tends to target those with compromised immune systems.  Because these are also patients with serious conditions and existing changes of fatality, as many as half may die when contracting the condition, making isolation and treatment early on a key.

[Note – Kalorama covers mycology testing market sizing and forecasting in its report  Infectious Disease Diagnostics, World Market Analysis ]

The disease has taken a particular statistical bent in the New York City area, where two-thirds of the cases were reported.

The fungal infection is tricky to diagnose, though that opens up an opportunity for mass spectrometry-based IVD systems to contribute to detection during the outbreak.

“Diagnostic devices based on matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) can differentiate C. auris from other Candida species, but not all the reference databases included in MALDI-TOF devices allow for detection,” according to the CDC guidance.

Sequencing-based molecular methods based on sequencing the D1-D2 region of the 28s rDNA or the Internal Transcribed Region (ITS) of rDNA also can identify C. auris.   Other products, such as PCR, can identify fungal infection absent a specific C. auris designation:

T2 Biosystems’  T2Candida® Panel identify the most serious bacterial and fungal pathogens directly from blood sample in just three to five hours, without waiting for a positive blood culture —which can take one to six or more days.  The FDA-cleared and CE marked test runs on a desktop analyzer based on magnetic resonance imaging and provides results within five hours.

Thermo Fisher’s RapID YEAST PLUS System, a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like and related organisms which have been isolated from human clinical specimens.  It does not specify C. auris at time of reporting, but can signify candida infection which can suggest further testing.

The CDC also said that laboratories with capability to characterize isolates further when C. auris is suspected are encouraged to do so. Suspected isolates can also be sent to CDC’s AR Lab Network for identification and antifungal susceptibility testing.  This testing is performed free of charge and may require coordination through the State Public Health Department’s Healthcare-associated Infection (HAI) Program.  The CDC advises that Isolates should be submitted on slants shipped at room temperature.   Futher, mycology specific media are not necessary if the laboratory does not have them. C. auris can grow on blood or chocolate agar slants.

In China, reaction to the disease is more stated though cases are also lower and not likely to cause an epidemic in China, according to an article in in China Daily http://www.ecns.cn/news/2019-04-12/detail-ifzhhxra9209972.shtml.  The country’s medical authorities are concentrating on patients with serious disease or undergoing chemotherapy.

 

 

 

 

 

 

 

Pittcon 2019 now in its 70th year, meets in Philadelphia this week.  The meeting is an opportunity to showcase improvements in laboratory technology.  While mass spectrometry and liquid chromatography are key areas for vendors, this year’s meeting will feature a large demonstration space where vendors will show off spectrometry, software and even analyze common everyday beverages to demonstrate their system features.

Bioinformatics Inc., Kalorama Information and related companies will be present with a large team.  Kalorama Information’s partner publication SDi (STRATEGIC DIRECTIONS INTERNATIONAL)  recently published its 80+ instrument market analysis report, Global Assessment 2019, https://bioinfoinc.com/product/2019-sdi-global-report-analytical-life-science-industry/.  The report covers the bulk of the industry at the meeting.

A few noticeable early announcements are on our radar:

 Bruker Biosciences will exhibit a new inert gas fusion (IGF) analyzer.  The new G6 LEONARDOTM is an economic, robust and precise inert gas fusion (IGF) analyzer for oxygen, nitrogen and hydrogen (ONH) concentration measurements in inorganic samples.  With its pre-calibrated standard methods and argon gas instead of helium, the G6 LEONARDO addresses the needs of industrial process and QC for easy and cost-effective operation.

Bruker also announced a new software acquisition intended to help manage pharamceutical projects.  Bruker announced that it has acquired Arxspan LLC , a provider of cloud-based scientific software and workflow solutions. Arxspan is known for its line of cloud-based products for the management of research data, with a focus on serving pharmaceutical and biopharma customers.

“Known-Knowns” and “Unknown-Unknowns”

Among many other show developments and announcements, Thermo Fisher Scientific will host two seminars dedicated to small-molecule.  The company will inform attendees of its new software solutions coupled to a new Orbitrap HRAM mass spectrometer to tackle the challenge of capturing sufficient, high-quality MSn fragmentation spectra for each component within complex samples. The company says these new solutions revolutionize the process and effectiveness of confident compound characterization of known-knowns, known-unknowns, and unknown-unknowns.

In another seminar, Thermo will feature New dual-LC technology and single-quadrupole MS provide opportunities to increase throughput by analyzing samples more efficiently and reduce operational costs by optimizing bench space. Learn how these systems can be used for efficient characterization of (bio)pharmaceuticals, fast method development, and comprehensive separation and detection of complex samples.  The Vanquish Duo for Dual LC houses two flow paths in one system to save space and improve returns.

Waters Corp. will demonstrate it’s Automated PeakTracker in Fusion QbD for Advanced LC and LC/MS Method Development a new platform that dramatically advances chromatographic method development:   Waters Empower CDS with Fusion QbD® Software containing PeakTracker™, the Waters ACQUITY H-Class PLUS UPLC, PDA detection, and ACQUITY QDa Mass Detector.

The company says that PeakTracker is a new automated peak tracking technology that optimizes and simplifies mass detection in the method development workflow. Complex separation challenges addressed includes.  Partially co-eluted peaks assigned the same mass, Completely co-eluted peaks resulting in missing data.

“Beverage Identification” on Display

 Waters is hosting a “Kool Aid Never Looked So Good” Separation Challenge to test sample preparation skills on the exhibit floor Thursday.  Participants will be given two “mystery” samples and some clues about the products. Using solid-phase extraction, they will guess the food dyes, order of elution and complete a separation in less than one minute.   Judging will be based on the accuracy of your guesses and the performance of separation.

PITTCONN Philadelphia will boast two live demo areas where attendees can participate in 20-minute, interactive product demonstrations. The dedicated areas will cover topics such as air monitoring, new techniques in water testing, innovative products to increase lab efficiency, and recent developments in spectroscopy, spectral databases, and techniques for using hazardous materials.  Among the events at the  “Live Demo” areas include:

  • Is your coffee really decaf? Lumex Instruments will test that, using capillary electrophoresis technology.
  • Trajan Scientific and Medical will demonstrate its two automated systems for performing Liquid-Liquid extractions [LLE] on a micro scale. They can be applied as effective alternatives to the time-consuming manual processes
  • Sartorius will exhibit its “Next-Generation” balances for high performance lab use.  Balances feature a 0.1 mg resolution at 64 g, 124 g, or 224 g. capacities.  Each is available with or without an internal calibration weight.
  • Shimadzu Scientific Instruments will display its Elemental Analysis: EDX-7000 X-ray Fluorescence Spectrometer Bench-top energy dispersive X-ray fluorescence instrumentation can provide a safe, fast and easy alternative to more difficult and expensive technologies like Atomic Absorption (AA), Optical Emission Spectroscopy (ICP-OES) and Mass Spectrometry (ICP-MS).
  • Bio-Rad Laboratories will demonstrate its Bio-Rad’s KnowItAll® Solutions, combining  IR & Raman spectroscopy with spectral analysis software
  • HORIBA Scientific will demonstrate in nanoparticle identification, quantification, and sizing by nanoparticle tracking
  • Cerno Bioscience will present its GC/MS Compound ID Using Accurate Mass and Automated Mixture Detection

 

 

 

News came this week that the Department of Veterans Affairs awarded Foundation Medicine, a Cambridge, MA- based molecular testing company, a significant contract to provide genomic profiling for veterans helps to validate the growing use of NGS and liquid biopsy for diagnostics.

The contract was reported to be at 111.5 million over five years. It covers several of Roche-owned Foundation’s tests including Foundation One CDx, Foundation One Liquid, Foundation One Heme. These tests provide profiles that can be used in precision cancer, therapy-matching approaches. The VA said the goal of the program is to provide tumor sequencing for all veterans. 60 hospitals reportedly provide specimens for sequencing, with expansion planned. Prostate cancer is a particular target area, because of the need for early detection and treatment action, according to the agency.
“The development is a validation for the use of these tests, and more broadly, for the approach of performing comprehensive analysis, versus single-gene or small gene panel approaches,” said Justin Saeks, Kalorama Information’s Next Generation Sequencing Survey report that the firm published last year.
Kalorama believes it is good news for Roche, with large potential for service revenues; the company has seen its NGS market share slip consistently despite acquisitions and collaborations.

“The company actually had first-to-market advantage initially in the NGS market, but its share diminished over the years as competitors introduced higher performing, more economical systems and continuously provided upgrades,” Saeks said.
For more information, Kalorama Information’s most recent Next Generation Sequencing Market is located at: https://www.kaloramainformation.com/Generation-Sequencing-Instrumentation-Consumables-Services-Competitive-Trends-11594541/

The size and prestige of the VA could even portend an increased tendency towards services for diagnostics testing, sending tests out to labs, as opposed to the common practice of medical centers running NGS tests in-house. This would be more likely for comprehensive analysis, which requires more sequences to be covered than the tests that analyze small sets of genes

Next-generation sequencing (NGS) in diagnostics is rapidly growing, having made great strides since the conclusion of the Human Genome Project fifteen years ago. Increasingly rapid and effective testing capabilities for hereditary diseases, cancers, cardiac and respiratory conditions, neurodegenerative disorders, and even infectious disease, are either on the horizon or have arrived. The promise of DNA sequencing through this methodology alone has attracted many companies, researchers, and investors.The Worldwide Market forIn VitroDiagnostics, 11th Edition, has been released recently, and features a significant section on molecular diagnostics, including NGS. Below is a selection of developments that have arisen in the period since our report’s August publication.

In July, Genepath Laboratories (Chatswood, NSW, Australia) launched their NextGen test, a genetic screening test for use in detecting multiple treatable conditions, in conjunction with the heel-prick newborn screening test. NextGen can screen for over 60 serious medical conditions—50 of which were not previously tested in Australia—including conditions associated with sudden infant death syndrome (SIDS), life threatening conditions like tyrosinemia and familial hemophagocytic lymphohistiocytosis, conditions that cause developmental disabilities in both physical growth and intellect, conditions leading to heart and lung diseases, and rare cancers. Sample collection for the NGS panel is a simple mouth swab that can be performed on patients of any age, but is best for newborns as the targeted conditions usually appear in the first year of life. Among the conditions tested is familial hypercholesterolemia, a condition—easily treated through diet and medication—that significantly increases risk for myocardial infarction in young adults, and is estimated to be severely underdiagnosed in Australia.

Women’s health company NxGen MDx (Grand Rapids, MI) also announced in July that they had developed a new method of DNA tagging, called active molecular identification (AMI), to track samples and prevent laboratory errors, using synthetic DNA to tag a patient’s sample at the beginning of the testing process. AMI tagging accompanies and identifies the patient’s sample throughout the entire process, and connects it to the final test results, reducing the incidence of sample mixups. Validation studies were conducted to ensure that the synthetic DNA used in the methodology does not affect testing.

Meanwhile, it was announced in August that a five-year NIH grant valued at over $8 million had been awarded for research on the clinical and economic benefits of conducting NGS testing in newborns at multiple institutions, including Cincinnati Children’s Hospital, Mt. Sinai Hospital, Rady Institute for Genomic Medicine, Tufts Medical Center, University of North Carolina-Chapel Hill, and the University of Pittsburgh. Four hundred newborns known to be at high-risk for genetic diseases, but have not yet been diagnosed, will be enrolled in the study and will receive whole-genome and targeted genomic sequencing to test for over 1,700 genetic disorders. The multiplex panel is under development with Quest Diagnostics. Results will be compared with more conventional diagnostic procedures, with focus on time to diagnosis, time to treatment, and the total costs associated with each methodology.

An article to be published in theJournal of Global Antimicrobial Resistance (DOI:10.1016/j.jgar.2018.08.018; available online, currently in press), illustrates the potential of whole-genome sequencing in more rapid and comprehensive diagnosis of drug resistant tuberculosis. A study conducted in Indonesia, which has the world’s second highest TB burden, involved the use of WGS on over 300 samples from HIV-negative TB patients, among which, nearly 16% were found to have drug-resistant strains of the disease. The concurrence rate between WGS-based testing and more conventional phenotypic drug susceptibility testing was high for rifampicin and isoniazid, but less so for streptomycin and ethambutol. A potential advantage of WGS-based testing is that testing by more conventional means has been shown to be poorly corresponded with reported prior treatment for TB, due to clinicians targeting only patients with previous treatment or other risk factors, resulting in many undetected drug-resistant cases. WGS-based testing is potentially helpful in limiting the spread of drug resistant TB by testing patients who lack such risk factors.

In August, Novogene Bioinformatics Technology (Beijing) announced approval for its NovoFocus NSCLC CDx assay by the China Food and Drug Administration. The NGS-based diagnostic analyzes tumor samples for multiple genomic mutations associated with non-small cell lung cancer, which accounts for approximately 80% of all lung cancer cases in China. Results from sequencing and analysis of ROS1, EGFR, and ALK can be used to identify NSCLC patients eligible for treatment with CFDA-approved cancer therapies including Crizotinib (XALKORI), Gefitinib (IRESSA), and Osimertinib (TAGRISSO), respectively. Other genes targeted in the panel are KRAS, BRAF, and PIK3CA. NovoFocus NSCLC CDx was developed on the Thermo Fisher Ion Proton sequencing platform.

Asuragen (Austin, TX) announced in September the expansion of its own oncology portfolio with the launch of their newly CE-markedQuantideX NGS DNA Hotspot 21 Kit. The kit is a next-generation sequencing panel designed to detect numerous tumor types, including those in colorectal cancer, melanoma, and non-small cell lung cancer. QuantideX NGS DNA Hotspot 21 uses Asuragen’s NGS-in-a-Box design and the company’s Sample-Aware bioinformatics software, which determines whether a sample has sufficient DNA that can be amplified. The panel is indicated for use on Illumina’s MiSeq platform.

IDbyDNA (San Francisco) signed a licensing agreement mid-September with Fleury Group (São Paulo, Brazil) to offer the company’sExplify platform for clinical metagenomic testing in South America, with Fleury integrating the platform into its own laboratory operations. Fleury will also develop a full suite of clinical tests for Explify, beginning with a respiratory panel that detects over 200 common, rare, and novel bacterial, viral, and fungal pathogens in respiratory specimens.

IDbyDNA, which developed Explify in collaboration with ARUP Laboratories (Salt Lake City), is in another partnership, begun in January with Locus Biosciences (Morrisville, NC), to develop a diagnostic test for the Explify platform to detect Pseudomonas æruginosa. Locus will use the test to recruit and select patients for its clinical trial for LBx-PA01, a CRISPR-based antimicrobial product that targets the pathogen, which is associated with sepsis and a number of nosocomial infections.

Jerusalem-based NovellusDx will merge with a newly-formed Israeli subsidiary of Cancer Genomics (Rutherford, NJ), which will combine the former’s expansive cancer test portfolio and large tumor biology dataset with the latter’s proprietary NGS and machine learning tech. Cancer Genomics will be the surviving entity, but NovellusDx shareholders will gain a 49% stake in the company as part of the merger agreement.

Miami-based Igenomix has developed the Analysis of Infectious Chronic Endometritis (ALICE), an NGS-based diagnostic for the uterine infection that can lead to infertility in women. As traditional diagnostic methods do not accurately identify the bacteria in endometritis, nonspecific antibiotics are often prescribed and will not always be as effective as the infection requires. ALICE requires just a small endometrial sample from which DNA is extracted; the sample undergoes bacterial analysis through next-generation sequencing. With ALICE, clinicians can detect the correct culprit and prescribe the right pro- and antibiotic to treat the infection, and improve women’s reproductive success.

Again, for the latest market analysis of next-generation sequencing-based IVD, see the eleventh edition of our flagship report,The Worldwide Market forIn VitroDiagnostics, published in August.

Kalorama Information notes 4 trends in monoclonal antibodies (mAbs) – large protein molecules produced by white blood cells that seek out and destroy harmful foreign substances – topped $100 billion in 2017, according to Kalorama Information What’s Trending in Monoclonal Antibodies, examines the several types of monoclonal antibodies on the market and in development, looking at the mAbs market by structure, by target, and by indication.

  • Humanized mAbs Grow: Advancements in human and humanized monoclonal antibodies will be the major areas of development and growth through 2022.  Humanized mAbs will outpace all other structure types with compound annual growth of 13.5%.  More than $20 billion in revenues will be generated from new approvals in humanized mAbs over the forecast.
  • Watch for growth from PD-1 and PD-L1 mAbs.  These segments will show some of the strongest increases over the forecast.  Cancer indications are driving sales in these categories and are expected to maintain pace, increasing at CAGR of 38.4% for PD-1 and 21.5% for PD-L1 from 2017-2022.  Interleukin mAbs will also enjoy strong adoption.  More than $25 billion will come from developments and approvals between 2018 and 2022.
  • Neuro mAbs a Particular Focus: Steady growth is expected from oncology and autoimmune disease categories, as expected.  But new growth is projected in the neurological  segment with many mAb development programs moving froward in the area of Alzheimer’s disease.
  • United States First: The U.S. is the strongest mAb market with 56% market share and expected to maintain growth, accounting for 57% of the market in 2022, or $97 billion, an increase of 11.6%.

Further, the report discusses the several factors contributing to the strong growth of the monoclonal antibodies market. Company profiles of the major participants in the mAbs market are provided as well. What’s Trending in Monoclonal Antibodies (Markets by Structure, by Target, and by Indication) can be found at: https://www.kaloramainformation.com/Trending-Monoclonal-Antibodies-Structure-Target-Indication-11440829/.