Sample Expansion, Technology Improvement Defines POC Opportunity

From Kalorama Information’s new report on Point of Care Markets:

Technological progress is expanding the domain of rapid and point-of-care tests. Led by the U.S. population, the global client base for POC products and tests (including physician offices and other primary care settings such as clinics and mobile labs) is significant – accounting for $23 billion in sales in 2018 – and will endure through episodes of healthcare expansion and reform found worldwide. However, the role of POC tests remains contentious due to questions regarding quality control or accuracy and added costs. In the United States, results of the GPA Waived Project have vindicated regulatory concerns regarding the quality of CLIA-waived testing that have also stalled the introduction of additional test waivers. Skepticism regarding POC test accuracy is significantly stronger abroad, with much more limited test menus for reimbursement or outright bans on testing at unaudited or uncertified office labs.

POC Sample Type Expansion

An alternate sample type that has been used for many years is urine.  However, many analytes commonly tested in blood (or serum, or plasma) are not present in urine.  Also, while urine samples have some advantages over blood, testing urine specimens presents a different set of issues for clinical laboratories.  Also, while urine samples have some advantages over blood, testing urine specimens presents a different set of issues for clinical laboratories.  Today, urine specimens are important for certain types of IVD testing.  Urinalysis can be performed to detect certain metabolic disorders, kidney disease, bladder cancer, urinary tract infections, and certain other conditions.  Urine is also a commonly used type of specimen for drugs of abuse testing.

The use of saliva as a sample for diagnostic testing has been growing significantly over the past decade.  From a safety perspective, healthcare providers and laboratory personnel are at minimal risk of contracting an infection during the collection and processing of saliva samples, compared to blood which can transmit infections such as HIV, hepatitis B, hepatitis C, and others.  Getting a sample of saliva rather than blood can be easier with children or certain other patients.  Also, while some training is still required, individuals obtaining a saliva specimen require less training than do phlebotomists who draw blood.

Many biomarkers that are commonly measured in blood specimens can also be detected in saliva.  These include small molecules such as hormones, and also various drugs and drug metabolites.  Antibodies (such as antibodies to HIV) can be detected in saliva.  Also, nucleic acids are present in saliva, and saliva samples are now used as a source of DNA for genotyping analysis.

However, there are drawbacks to saliva as a specimen for diagnostic testing.  For example, mucoproteins found in saliva cause the saliva to be thick and sticky, difficult to handle and measure precisely.  There are substances in saliva that can interfere with immunoassays.  Also, there are enzymes in saliva that can degrade some analytes.  Even though saliva is a non-invasive type of specimen, saliva samples must be treated and processed properly.

Today, several companies that market drugs of abuse testing also offer tests to measure alcohol levels in saliva or oral fluids.  Some also market tests for drugs of abuse in saliva samples.

Outside of drugs of abuse and alcohol testing, the most successful company in saliva diagnostics is OraSure Technologies.  OraSure reported total revenues of $177.4 million  for 2018.  OraSure sees a future in molecular testing with saliva samples.  In August 2011, OraSure acquired DNA Genotek Inc (Canada), a small company that sold oral fluid collection kits used to collect samples of genetic material (DNA and RNA) for molecular diagnostic applications.

A number of breath-based tests have also reached the market.  Exhaled breath contains large numbers of volatile organic compounds (VOCs) that can be detected.  Some of these VOCs have been correlated with diseases. The concept of using exhaled breath as a test sample is not new.  Breath testing has been used to measure blood levels of alcohol for many years.

In 1999, The American Thoracic Society published guidelines for standardized procedures for measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide.  Breath tests are also on the market for CO (carbon monoxide) testing, H. pylori, and certain others.

While it is relatively simple to collect a breath sample in a physician’s office or at home, testing that sample can be an issue.  Some companies require that the breath samples be sent to their laboratories for analysis.  Menssana Research has developed the Breathscanner, which is a mobile POC system that can be used anywhere that has an internet connection.  The Breathscanner is used with BreathLink, a cloud application for collection, concentration, and analysis of VOCs in human breath

Drager’s new Alcotest 5820 is the latest generation of breath alcohol testing devices. The product is compact, handheld and provides reliable measurements with very short response times.

General Market Outlook

This White Paper scope cannot present a complete market picture of the point-of-care market.  Kalorama Information’s report contains detailed market analysis of each important segment.

Several outstanding market factors that have recently affected the overall IVD markets of the United States and Europe will also work against the stronger growth once expected of POC test markets: persistent fiscal pressure on lab testing under many payer systems worldwide, economic weakness in Europe, and healthcare system consolidation. Although only moderately strong at over 6.1%, the projected growth rate of the POC market will outpace projected overall IVD market growth rate at 4% per year. The projection assumes reduced investment activity by POC testing companies in terms of expanding capabilities – primarily through the placement of analyzers – as moderate complexity testing by office labs has seen little growth and consolidation in healthcare systems will lead to increased outsourcing. Europe has a significantly harder road ahead as overall IVD markets in many countries have yet to recover and certain near-patient tests have been abandoned to outsourcing due to unprofitability or even losses as reimbursement does not cover test costs.

Remaining demand for POC tests from the rest of the world is widely distributed among negligible and nascent markets. Promising developments in emerging regions include the introduction and success of Western-style physician practices and multi-specialty clinics that perform many standard POC rapid tests. Infectious disease tests are also an important component of the RoW POC market as NGO and government spending intensifies to improve disease surveillance and preventative care. Markets for rapid tests in emerging regions are largely a product of demand for hospital-based POC tests and rapid tests used in resource-challenged clinical labs in the developing world. Selected POC segments represent higher growth prospects for vendors and manufacturers due to clinical drivers in established POC markets (United States, Europe) and developing markets alike.