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August 14, 2014

Point-of-Care Reaches a Crossroads

As diagnostic variety expands, so too do the challenges.

Point-of-Care Reaches a Crossroads

The point-of-care testing market can expect significant growth, but cost and compliance challenges still exist. [© Photographee.eu - Fotolia.com]

  • Point-of-care testing (POCT) is among the fastest-growing areas of laboratory medicine, driven by clinicians’ increased need for technologies that are faster, cheaper, and provide more robust, clinically useful results than ever—a need fueled more recently by the ongoing restructuring of U.S. healthcare through the Affordable Care Act (ACA).

    The POCT market is projected to grow to $27.5 billion by 2018 based on a compound annual growth rate of 9.3% since 2013 (MarketsandMarkets), which would peg the current market size at a little over $16 billion. Glucose tests remain the majority of the POCT market—53.7% in 2013 (Reportlinker.com)—but have fallen from 70% in 2011 (RnR Market Research), reflecting expanded use of POCT.

    POCT is broad enough to take in the processing lab’s traditional molecular diagnostics increasingly seen in hospitals, home pregnancy or glucose tests, and “rapid diagnostic tests” or RDTs. “Rapid” can range from seconds to hours while patients wait, as long as it’s within a clinical encounter that allows for quick decision-making by the clinician.

    Several factors have driven POCT growth; Harry Glorikian, a life sciences and healthcare industry consultant, told Clinical OMICs that in addition to continued demand for more rapid results, clinical practices have been drawn to point-of-care testing by:

    • Its increasing ability to satisfy the need for analyzing more patient data
    • New technologies that allow small POCT devices to yield quality of results previously only available in large, centralized devices
    • New outcomes-based guidelines that offer incentives for enhanced patient care through POCT

    “The market is very promising. It is fraught with peril for many reasons—but we have seen quite a few changes in this area pointing to the opportunity for significant growth,” said Glorikian, a co-founder and former managing partner of Scientia Advisors. “What concerns me most is the ability of organizations to commercialize their products. A great deal of change is taking place because of the ACA. The way we used to do things and the way we need to do things going forward are different.”

  • Keeping It Simple

    POCT growth reflects clinical practices both introducing new tests and supplanting older ones with quicker, more compact, and often more reliable diagnostics.

    “Those are being adopted particularly in the outpatient setting, physician-office practices. They are simple technologies, they are single-card or single-kit tests like for pregnancy or rapid strep or rapid flu, so they don’t have to buy large instrumentation. It’s easy to train someone on how to do this. That’s one reason why it’s growing in popularity,” James H. Nichols, Ph.D., associate medical director for clinical operations and medical director, clinical chemistry at Vanderbilt University School of Medicine (VUSM), told Clinical OMICs.

    Traditional rapid diagnostics such as vaginal fluid tests for bacterial vaginosis, urinalysis for hemoglobin a1c, or creatinine blood tests for renal damage have been joined by tests for HIV, such as blood tests that count T cells expressing CD4 (particularly useful in Africa) and diagnostics for other infectious disease, from STDs to hospital nosocomial infections.

    Inpatient practices and core labs are also increasingly using POCT for traditional glucose testing as well as some coagulation tests linked to cardiovascular procedures, from chest pains or clogged arteries to open-heart surgery and transplantation. As with other diagnostics, POCT has been driven by major disease areas like cardiovascular disease, diabetes, and neurological disorders.

    Dr. Nichols, a VUSM professor of pathology, microbiology, and immunology, also noted that POCT has also grown in hospital emergency rooms due to applications ranging from chemistry assays to cardiac markers like those for troponins and BNP for congestive heart failure.

    One POCT developer focused on critical care is Luoxis, which in April won CE marking in Europe for its RedoxSYS™ Diagnostic System, a first-in-class, blood-based clinical diagnostic platform. The system is designed to measure oxidation-reduction potential (ORP), a homeostatic measurement of oxidative stress that changes in response to traumatic injury or illness.

    Luoxis, a majority-owned subsidiary of publicly traded Ampio Pharmaceuticals, plans to launch RedoxSYS in Europe next year while continuing clinical studies toward obtaining FDA 510(k) clearance. The company envisions key critical care applications including monitoring injury severity and oxidative stress following multitrauma injury or traumatic brain injury (TBI).

    “Clinicians many times are feeling their way around the dark with these patients, using crude tools that have been around since the ‘50s, ‘60s, and ‘70s, that really haven’t advanced that much,” Josh Disbrow, Luoxis’ president and CEO, told Clinical OMICs.

  • Cost, Compliance Challenges

    For physician practices using POCT, one key challenge is cost. Because physician practices carry out lower numbers of tests than larger providers, they cannot benefit from volume discount-type contracts with manufacturers. Many of the costs approach or even exceed reimbursement level.

    William Clarke, Ph.D., director of clinical toxicology and POCT at Johns Hopkins University School of Medicine, told Clinical OMICs point-of-care tests cost significantly more than central lab tests—sometimes by a factor of 10 or more.  Cost differential depends on the analyte and POCT device or platform.

    “If a central lab test costs $1, and a POC test costs $15, then operational costs are significantly increased. However, if that same test is able to lead to fewer adverse events or decrease average length of stay, then thousands of dollars (or more) can be saved,” Dr. Clarke said. “The question becomes how many POCT tests must be performed in order to see the costs savings, and then examining the balance between increased operational costs and decreased cost of care.”

    Another challenge is regulatory compliance. While Clinical Laboratory Improvement Amendments of 1988 (CLIA) rules are waived for some POCT tests, diagnostics of moderate or high complexity require FDA documentation of training, proficiency testing, competency of staff, quality control, and maintenance logs. Also, several states require licensure for test conductors. Yet many who perform POCT have less experience than lab-trained individuals, heightening concerns about POCT’s ability to deliver long-term accurate, precise or reliable results, Dr. Nichols said.

    Despite Illumina’s HiSeq x 100 winning the first FDA premarket clearance for a next-generation sequencing system, NGS technology has seen limited uptake in POCT, due to the complexity of the technology, and the need to pair new technologies with improvement in patient outcome. A rapid flu test may perform well against this year’s influenza strains, but as strains vary each year, so too may test results. By contrast, creatinine test turnaround time and quality can be linked directly with kidney function.

    Looking ahead, Dr. Nichols envisions POCT expanding beyond traditional technologies through increased use of smartphones. Where patients cannot see their doctor, or are under home nursing care or follow-up care, clinicians will increasingly use their phones to read and transmit the results that require documentation.

    Smartphone-based home testing, Dr. Clarke said, will be an important part of managing chronic diseases in the changing healthcare environment. Challenges for home testers will be not only managing regulatory requirements, but also managing the information flow; in many instances, home testing will be direct-to-consumer.

    “How will that information be interpreted and used?” Dr. Clarke said. “For some tests, the interpretations are straightforward, but for others there may be significant challenges or potential for misinterpretation by someone that is not educated in laboratory medicine or healthcare in general. Is that risk worth the perceived opportunity? I’m not so sure.”

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