Kalorama has released its 12th Edition of The Worldwide Market for In Vitro Diagnostic Tests.  It is a complete market study of the 69+ billion-dollar industry.   Among the report’s findings are the following:

  1. Some Improvement in European IVD Markets: Kalorama found reversed austerity, LDT spending, and test innovation increased Europe market size, somewhat.  As Europe is an important market, this boosted the IVD market as a whole.
  2. New Disease Threats Impacting Blood Bank Market: More nations are testing blood in greater quantities and demand is needed to discover infectious disease threats.
  3. Cancer and Infectious Disease driving Growth – tumor markers, blood-based cancer assays, in situ hybridization are among the cancer tests driving growth.  So is infectious disease testing, both common pathogens such as hepatitis and HIV, but also newer threats such as Ebola, Zika, WNV and others.
  4. Clear Majority (near 60%) of Market Outside US – More growth is coming from more parts of the world.  Look to new emerging markets beyond China, India and Brazil.  Country markets are detailed in this report.
  5. Clinical Diagnostics Usage of Mass Spectrometry Growing – once a research tool, now MS has found its place in diagnostic testing.  Kalorama reports market size and forecasts in this area, for infectious disease and non-micro testing.
  6. Companies “Buy to Grow”  Merger activity is robust in the in vitro diagnostic market as even major players cannot do everything they need to do alone.  60+ acquisitions detailed in this report.

Kalorama’s report provides market sizing and forecasts for every significant in vitro diagnostics test category, including clinical chemistry, immunoassays, hematology, molecular diagnostics, blood banking, inherited disease testing, tumor markers, histology and cytology, coagulation and more.   In addition, trends are covered such as: emerging markets, lab-developed tests, point of care (with market forecasts by POC category), distribution deals and partnerships, NGS in clinical diagnostics, rare disease testing, the current state of PGx and more.

 

 

Announcing a new product from Kalorama Information, Part of the Science and Medicine Group.  The  Kalorama Clinical Masterfile.

For the best business results, clinical diagnostics marketers need knowledge about several elements:

  • What products do my customers currently have?
  • What types of products? Clinical Chemistry, Micro, Molecular, Immunoassays, Hematology?
  • How old are those systems?  Is it likely they would seek replacement?
  • How is my competition doing?
  • How can I verify customer data that my sales staff provides?
  • What is their budget?
  • Who is in charge of buying these systems?

The Kalorama Clinical Masterfile is designed to help answer these questions.  It is the most comprehensive database of the installed base of clinical laboratory equipment in the U.S.  It is based on an ongoing survey of more than 5,300 facilities continuously updates data on more than 41,000 analyzers including manufacturer, model, number installed, year installed and department location.

The information is continuously gathered by phone and online reporting system with pathologists and lab managers at U.S. CLIA labs.  Every major modality is covered including chemistry, coagulation, hematology, immunoassay, integrated systems, microbiology, and molecular diagnostics.

The Masterfile is based on an ongoing survey of more than 5,300 facilities continuously updates data on more than 41,000 analyzers including manufacturer, model, number installed, year installed and department location.

Key demographics such as address, population served, budget and points-of-contact. The product is sold on a 12 month license, with quarterly updates included.  More information is available at: https://kaloramainformation.com/kalorama-clinical-masterfiledefinitive-information-on-u-s-clinical-diagnostics-instruments/

Each facility’s record in the MasterFile contains: 
  • 1. Facility Information
    IMV Master ID, AHA (American Hospital Association) ID, Medicare Provider (CMS) ID, Facility Name, Facility Address, Facility Phone Number (General),    Last Interview Date
  • 2. Key Demographics
    Population Served, Healthcare Spend (specific to Laboratory) ($), Spend Index
  • 3. Modalities / Areas CoveredChemistry, Coagulation, Hematology, Immunoassay, Integrated Systems, Microbiology, Molecular Diagnostics
  • 4. Installed Equipment
    Manufacturer, Model + Name / Number, Year Installed
    Department Location
  • 5. Contact Fields
    Name, Title, Institution ID (note that Client ID number can be added, if applicable)

See a Demo and Discuss the Clinical Masterfile:  

 Jonathan S. West
Business Development Director
Office: 1-703-778-3080 x 33
Mobile: 305.281.4720

Kalorama Information, a part of Science and Medicine Group, has announced that it has published its 25th report since the acquisition of the company by Science and Medicine Group. Since November, the firm has reported on food safety testing, infectious disease, Latin American Markets, molecular diagnostics and many other markets.

“Experts in sequencing, liquid biopsy, mass spectrometry are now available to us, as is an extensive network of clinical instrument placements and survey capabilities that can provide insights.”

Science and Medicine Group (then called Bioinformatics, Inc.) purchased Kalorama Information on November 1st, 2018. Previously the division was owned by MarketResearch.com

“Kalorama Information has been enhanced by the synergies present in an environment with healthcare and test instrument publishing partners,” said Bruce Carlson, Publisher of Kalorama Information and Senior Vice President of Publications for Science and Medicine Group. “Experts in sequencing, liquid biopsy, mass spectrometry are now available to us, as is an extensive network of clinical instrument placements and survey capabilities that can provide insights.”

Upcoming reports include a complete survey of laboratories using sequencing conducted by an expert with 2 decades of experience in biotech market research, a survey of clinical diagnostics customers relating customer experience and preferences. In August, the firm will publish its 12th Edition of the World Market for In Vitro Diagnostics.

“Our reports are quite different from the factory market research publishers that publish on cars this week, healthcare next week. Kalorama are based on real industry knowledge, experts put to the task, a focus on vendor actions versus academic modeling of industries.”

Kalorama’s website is available at www.kaloramainformation.com

As reported on LabPulse.com (Sign up at http:www.labpulse.com)

— Providers of proficiency testing for CLIA tests are becoming increasingly concerned about the lack of external quality control and oversight of CLIA-waived test kits, as the number of waived kits continues to expand. Some 1,400 waived test kits are now on the market, compared with 30 three decades ago.

Test kits that are waived from CLIA oversight are considered to be straightforward enough that they may be performed easily. But sometimes procedural mistakes occur when untrained clinical lab personnel work without the benefit of external quality assurance testing, and errors may not get picked up until the damage has been done.

Nearly three decades have passed since the U.S. Centers for Medicare and Medicaid Services (CMS) last updated CLIA regulations. Back then, only nine test methodologies, or test kits, were waived, but today, more than 1,400 test kits have been waived. Some test methodologies have become more complex and sophisticated over the years, but CLIA program regulations, which have not been updated for many years, have not taken into account newer test methodologies.

A test, or analyte, itself is not waived, but a methodology or test kit can be waived for CLIA oversight by the U.S. Food and Drug Administration (FDA). In February, CMS proposed adding 29 new analytes and deleting some existing tests in updated CLIA proficiency testing rules. Comments for the proposed changes are due on June 4.

While the proposed update addresses analyte regulation, it does not address waived test kits, which concerns proficiency testing organizations. Test kits are CLIA-waived because they are minimally technical. They use methodologies that are so simple and accurate that the likelihood of erroneous results is negligible. They use unprocessed specimens — whole blood or oral fluid — and pose no reasonable risk of harm to the patient if performed incorrectly. Some have been cleared by the FDA for home use.

Always room for error

“Waived testing is considered to be straightforward and uncomplicated enough that it may be performed by anyone able to read and follow the instructions on the testing kit’s package insert,” explained Christine Myers, senior associate with the medical lab evaluation program at the American College of Physicians, which offers a CMS-approved proficiency testing program.

“There are times, however, that procedural mistakes will happen when untrained personnel are running clinical laboratory tests without the benefit of external quality assurance testing, such as proficiency testing,” Myers said. “These errors can go on indefinitely unless something brings these mistakes to light, and this is usually only after a patient’s health has been negatively affected.”

For example, she noted that errors could lead to the misdiagnosis of an infectious disease or an unneeded increase or decrease in medication amounts to control glucose levels, based on flawed glucometer or hemoglobin A1c results.

“These types of errors may be caught when a laboratory participates in proficiency testing because testing compares test kit results against other labs using the same or similar testing methods,” Myers explained.

The main concern of proficiency testers is that without some type of external quality assurance testing, errors can go undetected for days or weeks before a serious situation brings problems to light. Moreover, two years or more can lapse between outside inspections of a laboratory performing waived testing in-house. If a lab is only doing waived testing, it may never be inspected by an outside agency — decisions on a patient’s diagnosis and treatment might be made based on flawed testing, and negative outcomes would result.

Alternatives to proficiency testing

Waived test kits can be submitted for proficiency testing. However, if proficiency testing is not a financial option for a lab, then the lab might consider performing split testing, in which a select number of patients are tested in-house and a duplicate sample is sent for testing at a reference or neighboring lab that participates and is successful with its own proficiency testing program, Myers explained. This would require additional work on the waived lab’s part as it would need to ensure that the testing is performed by a CLIA-licensed lab using the same or similar methods.

“The overall point is to offer quality tests and test kits with results that keep patients safe.”

— Christine Schimpf, American Academy of Family Physicians

Waived testing was supposed to include methodologies that were so simple that they would render reliable results, even if tested by people with no formal laboratory training, said Christine Schimpf, manager of proficiency testing at the American Academy of Family Physicians (AAFP). But the issue is that the methodologies have become more complicated — labs have quality control as well as checks and balances in place so that they do not get erroneous results, but errors still do occur, Myers said.

For example, many problems occur when test performers take shortcuts or don’t perform the test according to the manufacturer instructions, and they end up with results that are not as reliable as they should be, Myers added.

AAFP’s Proficiency Testing Program has client laboratories that use only waived test kits. Yet these labs enroll and participate in proficiency testing so that they would know how well the test kits and the labs’ staff have been performing. Schimpf is concerned that certain waived tests are not regulated and that incorrect results could affect patient safety. Waived test kits do not require daily quality control. These kits and tests only require quality control and oversight on each new lot of material or each time a new test kit is opened.

“Everything in the test kit is supposed to be in good shape. But problems could occur if a box of kits is left in the sun or if they are placed in a freezer by accident and they’re frozen,” she said, explaining that all these possibilities are in play. “You wouldn’t think that people would make those mistakes. But they do happen,” Schimpf noted.

Other problems occur when test results are incorrectly interpreted or when results are incorrectly entered into the patient’s report. Schimpf also expressed concerns that the proposed CMS rule does not address waived test kits, only regulated analytes.

“The overall point is to offer quality tests and test kits with results that keep patients safe,” Schimpf said.

 

Quidel is the market leader in point-of-care (POC) cardiac markers, according to a recent report from Kalorama Information. Abbott, Roche and Siemens Healthineers and Response Biomedical also are among the top companies. The findings were reported in Kalorama Information’s latest report, Worldwide Market for Point-of-Care (POC) Diagnostics.

Quidel is a market leader in rapid immunoassays and has significant exposure to the POC markets relative to its size and total revenue, according to the report. Quidel acquired the assets of the Triage business from Alere when Alere was acquired by Abbott in October 2017. The panel combines troponin I, CK-MB, myoglobin, B-type natriuretic peptide (BNP), and D-dimer to provide accurate results in whole blood and plasma. Quidel’s first products were dipstick pregnancy tests launched in 1984. Moving from its primary markets in rapid test kits, Quidel has in recent years introduced POC immunoanalyzers and rapid molecular tests to market.

Abbott with its i-STAT system is a leading provider of handheld cardiac marker tests. Siemens Healthineers and Roche compete in the market as well. Response Biomedical is a small company that develops, manufactures, and markets rapid on-site diagnostic tests for use with its RAMP system for clinical and environmental applications. The RAMP system consists of a portable fluorescent reader and single-use, disposable test cartridges.

Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as point of care. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments, including the workplace, home, disaster care, and, most recently, convenience clinics.

The menu for POC continues to expand. In the past five to 10 years, POC products were developed in the following categories: HbA1c, BNP, whole-blood lactate, D-dimer, and C-reactive protein (CRP).

Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued CLIA waiver status for their POC devices and the CE Mark for POC or self-use. At the same time, more decentralized test venues invest in nonwaived rapid tests and instruments. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care. New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation, or an electronic medical record.

About Kalorama Information

For more than 30 years, Kalorama Information has been a leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), imaging, biotechnology, healthcare, medical devices, and pharmaceuticals.

There has been a milestone reached in 2019, but not one to celebrate. There are now more cases of measles in the United States than any time since 1992.  1,077 individual measles cases were confirmed as of June 2019, according to the Centers for Disease Control and Prevention (CDC). With doctors less familiar than they once were in clinically detecting a disease that was largely eradicated, IVDs such as immunoassays and molecular tools are fortunately available and effective. Kalorama Information covers infectious disease in our report – Infectious Disease World Market Analysis.

This year Measles virus (MeV) cases have been reported this year in 22 states – Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Hampshire, New Jersey, New York, Oregon, Texas, Tennessee, and Washington. About 71% of people who have gotten sick from measles this year have been unvaccinated, 11% were vaccinated and the rest had an unknown status, according to a recent CDC Morbidity and Mortality Weekly Report. Symptoms include cold, fever, runny nose accompanied by a rash.

“Because of the disease’s decline, many doctors have not recently seen a measles case, and the rash can be confused with a number of other illnesses. So blood tests are useful to confirm whether if a rash is truly measles.”

Measles is not eradicated worldwide, though it is considered so in the United States. Globally, 451,756 suspected measles cases were registered in 2014. In 2013, the WHO estimated the global measles deaths to145,700. There is a tendency to think of measles as a children’s disease alone, but it is a deadly disease due to the immunosuppresion it can cause. It is also highly contagious human. It can result in complications like pneumonia, brain damage and deafness and can be fatal.

When last there was a noteworthy outbreak, In March 1990, a large measles outbreak began in New York City and other cities in the United States with significant unvacinnated populations. Through December 1990, approximately 2500 cases and eight measles-associated deaths were reported. The CDC and the Academy recommend children receive the first routine dose of MMR vaccine at 12-15 months and the second dose at 4-6 years. One dose is about 93% effective, and two doses are about 97% effective.

Normally, doctors can usually diagnose measles based on the disease’s noteworthy rash as well as a small, “Koplik’s spot” a bluish spot on the inside lining of the cheek. Because of the disease’s decline, many doctors have not recently seen a measles case, and the rash can be confused with a number of other illnesses. So blood tests are useful to confirm whether if a rash is truly measles.

Testing for measles is typically immunoassay-based as it is cost-effective. Enzyme-linked immunosorbent assay (ELISA) is normally used to quantify the amount of serum IgG antibodies against measles, mumps, rubella, and varicella-zoster virus. Examples are Roche’s Elecsys Rubella IgM, ELISA Anti-Measles-Virus/IgM test kit from Siemens Healthineers, Microimmune Ltd’s Measles IgM capture EIA. The method is time-consuming and in some cases, the IgM response is not detectable until 3 days after symptom onset. Some molecular tests are also availalble for more immediate detection, Roche MeVA RT-qPCR on the Roche LightCycler 480, QIAamp viral RNA mini kit, Creative Biogene and Fast Track Diagnostics also have products. Where not available, a second IgM test is often used to find late developing MeV.

News of an approval of a biosimilar for a major Roche cancer drug is, we think, evidence that U.S. biosimilars are a growth market opportunity.   At the same time, the approval is a growth limiter for booming cancer drug markets.  Pfizer Inc confirmed Friday that the the FDA approved its biosimilar to Avastin. Pfizer’s Zirabev received approval for the treatment of five types of cancer, including colorectal and lung cancers.

The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

Undeniably the top targets for biosimilars are beginning to hit the market. Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan/MabThera (rituximab), and AbbVie’s Humira (adalimumab) will be experiencing the most pressure from biosimilars. Europe is leading the biosimilar charge worldwide. The US is lagging behind due to legal and regulatory issues that continue to plague the industry but is expected to explode in 2023.  Kalorama Information started watching this industry early in 2002 and now a clear growth pathway in the U.S. is seen.

Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic acids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biosimilars are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics.

“The global market for biosimilar products has grown to be worth $11.4 billion by 2019, adding to the growing strategies of cost savings and improved health outcomes. This according to Kalorama Information’s Biosimilar Market Trends 2019.

The worldwide prescription generic drug market has stood the test of time and has endured numerous growing pains. However, it has evolved into a formidable and important participant in the complex world of health care. Generic drugs continue to represent one of the greatest values in healthcare and are of great importance in the area of biopharmaceuticals as well because these products are among the most expensive treatments currently on the market. Generic drug manufacturers are poised for strong growth in the future because the patent protection for a host of major biopharmaceuticals will expire and new legislative reforms in the generic drug approval process are facilitating bringing products to market. While there are many issues to address, the outlook for biosimilar promotion is favorable in the next five years.

In 2017, U.S.-based Amgen Inc’s Mvasi was approved by the FDA as the first biosimilar to Roche’s Avastin, which brought in revenue of $6.85 billion to the Swiss drugmaker in 2018.

The 67th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, held recently in Atlanta, Georgia, is a major showcase for mass spectrometry system (MS) introductions. Below are some of the trends evident among the many system launches.

Small is Big

Agilent Technologies introduced the LC/MSD iQ single quadrupole MS, measuring 12 x 18.7 in (305 x 475 mm), and described it as 7 in shorter and 7 in shallower than its predecessor for an over a 50% reduction in size. A smaller size enables stacking with Agilent’s LC systems. The ease of use and smaller size targets chromatography users.

Shimadzu debuted the MALDImini-1, a 55 lb (25 kg), 11.7 x 16.5 in (297 x 420 mm) MALDI digital ion trap MS system. Size benefits include the ability to be located next to the sample preparation space. Performance specs comparable with larger systems include MSn capabilities.

Thermo Fisher Scientific also aimed to reduce size with the new Thermo Scientific Orbitrap Exploris 480, quadrupole-Orbitrap MS, measuring  534 × 763 × 703 mm (21 × 30 × 27.7 in), a quarter of the size of previous Exploris systems, and half the weight at 120 kg (265 lb) (without data system, vacuum rough pumps, and optional items). The system is designed for applications encompassing small and large molecules, with a wmass range of 40-6,000 m/z and the option of up to 8,000 m/z.

A Cell-ing Point for MS

Bruker’s new SpatialOMx solution enabled by the introduction of the TimsTOF flex MS addresses the need to measure both spatial and temporal characteristics of cellular tumors. It combines MALDI imaging with TimsTOF MS capabilities in one system. Applications include investigation of the correlation of RNAseq results with protein expression in the same sample.

Thermo Fisher Scientific highlighted the use of the new Orbitrap Eclilpse Tribrid MS with TMT reagents and synchronous precursor selection-based MS3 technology for single-cell analysis studies. Proteins in a single cell were identified with a subset quantified, providing information on cell type and cell state.

Flexing Functionality

SCIEX introduced the mid-range SCIEX Triple Quad 5500+ LC-MS/MS System–QTRAP Ready, enabling users to upgrade from a triple quadrupole MS system to a QTRAP for linear ion trap analysis and the added capability of MRM3.

Waters’ new SYNAPT XS provides flexibility with 10 acquisition modes, including Waters’ SONAR and HDMSE data independent acquisition modes, as well as multiple inlet options. It is designed to address a range of applications in drug discovery and characterization.

This article is from our partner publication Instrument Business Outlook https://instrumentbusinessoutlook.com/

For more on the Mass Spec market and new products, see our partner publication, SDi, and their latest MS report.

From our partner publication LabPulse.com: New recommendations released June 11 from the U.S. Preventive Services Task Force (USPSTF) continue to strongly advise HIV screening for adolescents and adults, and for the first time they support preventive treatment for those at high risk. The guidance could boost volume for blood tests.

Kalorama Information’s Infectious Disease World Market Analysis can be found here:  https://kaloramainformation.com/product/infectious-disease-diagnostics-world-market-analysis/

The USPSTF, a volunteer group of independent experts that makes evidence-based assessments for disease prevention, published two recommendation statements on HIV screening and preventive treatment in the Journal of the American Medical Association (Vol. 321:22, pp. 2203-2213). The USPSTF’s last guidance on this topic was published in 2013.

The group gave an “A” recommendation to screening for HIV in adolescents and adults between the ages of 15 and 65 years and for all pregnant women. Furthermore, it advised screening for people younger than 15 and older than 65 who are at risk of getting infected.

The USPSTF did not find enough evidence to set screening intervals, but it concluded that “repeat screening is reasonable for persons known to be at increased risk of HIV infection,” including sexually active men who have sex with men, people who inject drugs, and/or those who are involved with commercial sex work.

The USPSTF also released a new strong “A” recommendation for preventive treatment with antiretroviral medication of people at high risk for HIV. The USPSTF advised that this includes men who have sex with men, are sexually active, and meet one of the following criteria:

Has a sexual relationship with someone who is HIV-positive
Does not use condoms consistently during anal sex
Has had syphilis, gonorrhea, or chlamydia within the past six months.
Currently recommended antigen/antibody tests for HIV are highly accurate, with sensitivity ranging from 99.76% to 100% and specificity from 99.50% to 100%, the USPSTF advised.

“Recommended rapid HIV tests have similar sensitivity and somewhat lower reported specificity ranging from 98.6% to 100%,” the task force wrote in JAMA.

A lot of room to improve

The number of new HIV infections has been dropping — down from 41,200 in 2012 to 38,300 in 2017 — but fewer than half of adults in the U.S. have ever been tested for the virus.

“Approximately 15% of persons living with HIV are unaware of their infection,” the USPSTF authors noted. “It is estimated that persons unaware of their HIV status are responsible for 40% of transmission of HIV in the United States.”

Clinicians and healthcare professionals must do more to reach the 15% who are unaware of infection and account for a big number of new HIV transmissions, urged an editorial published online in JAMA Internal Medicine on June 11.

“Fortunately, new HIV tests are faster and more accurate than previous tests,” wrote Dr. Diane Havlir and Dr. Susan Buchbinder, both of UCSF. “At present, the window period between HIV infection and a positive antigen/antibody test result using a fourth-generation test is about 17 days, which can be reduced by nearly a week with HIV RNA testing.”

Havlir and Buchbinder also noted that in 2018, only 17% of the 1.1 million uninfected people who would be eligible for PrEP actually had a prescription at the end of 2018, and more needs to be done to reach certain at-risk groups, such as women, people younger than 25 years, and those who live in states that have not expanded Medicaid insurance. To reach populations at risk, it will be necessary to move beyond facility-based HIV testing, they wrote.

“Public health departments should support community-based models of HIV testing, including mobile and self-testing, and ensure robust partner-notification programs to identify and potentially curtail transmission of the virus,” Havlir and Buchbinder wrote.

Reducing barriers to testing

Dr. Paul Volberding, co-director at the UCSF-Gladstone Center for AIDS Research, told LabPulse.com he is not expecting a big uptick in testing overall as a result of the new USPSTF recommendations. But he hopes there will be an increase in testing of those at higher risk who have been missed to date.

“The main effect will be to reduce any barriers to testing that have allowed some infected persons to still be progressing in disease stage and transmitting to more people,” Volberding wrote in an emailed response to questions.

The change in the USPSTF recommendations follows a call at the highest level of government for an end to HIV. Earlier this year, President Donald Trump pledged an end to the epidemic in the U.S. within 10 years.

Many practical challenges remain, however. Massachusetts General Hospital infectious disease specialist Dr. Rochelle Walensky and Yale University’s David Paltiel, PhD, flagged the lack of attention to economic considerations in the 2019 HIV screening guidance in an editorial in JAMA Network Open.

“Testing for HIV, at about $25 per test, may be cheap, but each case of infection that is detected and successfully linked to care triggers a lifetime of [antiretroviral therapy], costing at least $40,000 annually,” Walensky and Paltiel wrote. “And at an annual cost of $20,000 per person, the drug component alone of a complete PrEP rollout for all those eligible would cost $24 billion annually.”

So while the USPSTF has taken an important step toward the goal of ending the HIV epidemic in the U.S., execution in the most at-risk communities will be crucial, they suggested.

Sign up for www.labpulse.com for breaking news updates.

Liquid biopsies are a set of minimally invasive diagnostic methods that analyze tumor-derived materials that can be found circulating in biological fluids, to provide information for the diagnosis, treatment, and monitoring of cancer. While tissue biopsies and imaging techniques remain the current standards of care in the diagnosis of solid tumors, they have risks and limitations and limitations, some of which can be overcome by the use of liquid biopsy in clinical oncology, as an alternative or complementary technique to the current standards of care.

The market is expected surpass $1.5 billion by 2023, according to our latest report,  World Market for Liquid Biopsy, 2018-2023. 

As of 2019, over 40 companies are active in the global market for liquid biopsy diagnostics and monitoring tests. The market for liquid biopsy testing, still in its infancy, is rapidly evolving as vendors develop and commercialize innovative new technologies to meet the needs of the clinical diagnostic market. Demand is also growing swiftly, at a projected CAGR of 27.9% over the next five years, as patients, clinicians, and payors increasingly accept liquid biopsy as an alternative or complementary procedure to traditional tissue biopsies.

Types of Analytes

Commercially available liquid biopsy tests target three main categories of analytes: circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), and exosomes (also called extracellular vesicles). Other analytes that are not a frequently targeted are cell-free RNA species (cfRNA), and proteins.

The most frequently targeted analyte in liquid biopsy is ctDNA, which encompasses small fragments of DNA that are believed to originate from the natural and abnormal necrosis and apoptosis processes undergone by solid tumor cells as well as normal cells during regular cellular turnover. The processes which generate ctDNA are accelerated in tumorigenesis, resulting in a greater abundance of ctDNA in biofluids, such as blood, urine, plasma, and cerebrospinal fluid. However, ctDNA is still found in relatively low concentrations, and has a short half-life in the bloodstream, which makes their isolation and identification challenging. Furthermore, the information that can be derived from ctDNA is limited to genomic sequence. ctDNA cannot provide information about transcription levels, translocations and fusions, or protein expression

The presence of ctDNA may also result from tumor cells killed by therapeutic drugs, and does not capture information about the residual cancer that may not respond to the particular therapy or has become resistant to it.

CTCs are a population of tumor cells that are believed to have detached from the primary tumor or metastatic tumor sites, and are found circulating in blood. CTCs are thought to be a fundamental process in metastasis. Because they are intact, viable cells they have a longer half-life in the circulatory system, and they offer several analytical advantages not possible with ctDNA analysis, including RNA and protein analysis, and intact genome. There are, however, significant challenges in capturing CTCs for analysis. CTCs are rare events and not always present in peripheral blood, even in the case of metastatic cancer patients. When present, their concentration is very low, in the range of one CTC among billions of red blood cells and millions of leucocytes. CTC markers may differ from those of primary tumor cells, and may also change over the course of therapy, making them difficult to target.

Exosomes are nanometer-sized extracellular membrane-bound vesicles secreted by cells to the extracellular environment on a continuous basis by most eukaryotic cells as a means of extracellular communication. They are highly stable in biological fluids, and, due to their miniscule size, can escape filtration by the kidneys to be found in urine, and can pass through the blood-brain barrier. Exosomes contain molecular information from their parental cells, by encapsulating proteins and various nucleic acids such as double- and single-stranded DNA, mRNA, miRNA, and other non-coding RNA. This provides many analytical advantages over ctDNA. However, because exosomes are secreted by most cells, it is difficult to efficiently discriminate and isolate them from other types of extracellular vesicles in bodily fluids. Due to the complex composition of biological fluids, the detection and isolation of high purity exosomes is a long process that imposes the use of multiple techniques based on various parameters.