Point-of-Care Tests Likely to Become Bigger Factor in Lab Business Moving Forward

For decades, the mechanics of laboratory testing have been at a physical remove from the bulk of health care delivery. A blood draw or tissue sample is performed on a patient at one site and the material is transmitted to a lab for testing. The results are then sent back to the original site or yet another locale.

That model is likely to remain in place for decades to come. But the laboratory business is also likely to see a significant portion of the tests it performs shift to point-of-care (POC) testing.

Although POC testing has been around for decades itself, such assays require regulatory approval from the U.S. Food and Drug Administration, which is usually much more stringent than Clinical Laboratory Improvement Amendments. The bulkiness of POC test hardware has also made them a limited option for clinicians, who have mostly used them to perform very basic assays. Initially, POC tests were developed for glucose and blood gases in the 1980s. But even with significant advances in technology in the decades since, there are only about 100 POC tests currently available on the market, out of the thousands a typical laboratory can conduct.

Change in Market Forces
But a variety of factors have come into play in recent years that make POC testing a more desirable option. They include the proliferation of retail clinics at big box pharmacies—which makes performing such tests a more urgent matter—advances in technology, and the need for convenience. And while many POC tests are more expensive than assays performed in a large lab, they can still reduce the overall cost of rendering care by getting a patient treatment much sooner than waiting a day or two for test data.

According to a recent report by the National Institutes of Health, “the success of a potential shift from curative medicine, to predictive, personalized, and preemptive medicine could rely on the development of portable diagnostic and monitoring devices for point-of-care testing.”

As a result, there has been a demand for laboratory testing to become more mobile, whether through POC assays or other means. This may be best illustrated by the recent launch of DispatchHealth, a Denver-based enterprise that provides mobile healthcare services. Each of the vehicles it uses includes a CLIA-certified laboratory, apparently among the first-ever mobile labs to ever receive such certification.

“Consumers now have a new option to address individual health care needs without the expense, inconvenience and time requirements often associated with urgent and emergency care facilities,” said DispatchHealth Chief Executive Officer Mark Prather, M.D., in a statement. He declined to be interviewed for this article.

The retail clinic surge has also led to changes regarding how pharmacists are being trained. Roosevelt University’s College of Pharmacy in Chicago, one of the bigger pharmacy schools in the Midwest, has begun training and certifying its students to administer POC tests for maladies such as strep throat and influenza. With a certification in place, they can prescribe antibiotics or antiviral medications after a positive test without a physician’s prescription.

“I expect POC testing to become an even bigger phenomenon than all of the immunizing that is being done by pharmacists at community pharmacies all across the nation,” said Roosevelt College of Pharmacy Dean George MacKinnon in a statement.

Meanwhile, technological advances are making many POC tests—which even in smaller incarnations still often require a platform ranging in size from a desktop printer to a toaster—accessible from a smartphone. Researchers at the University of California at Los Angeles have developed an enzyme-linked immunosorbent assay (ELISA) platform that can be run through a smartphone with a special attachment that is produced by a 3-D printer. Traditional ELISA platforms are used to test for diseases such as HIV, West Nile virus, hepatitis B, mumps, measles, and herpes simplex.

The UCLA-developed device can scan the ELISA slide in the field and wirelessly send data back to a computer server. Test results are then transmitted back to the smartphone within 60 seconds. Field testing indicated the smartphone platform was 99.6 percent accurate in diagnosing mumps, 99.4 percent accurate diagnosing herpes, and 98.6 percent accurate diagnosing measles.

Johns Hopkins University has also developed a nucleic acid amplification testing (NAAT) chlamydia test that can also be processed in part by a smartphone, with the testing itself being performed in a device about the size of a coffee mug. Its test costs about $2 to administer, compared to the current $10 per test to perform a NAAT-based assay in conventional laboratory. Johns Hopkins officials say they hope the test will encourage more testing for the often asymptomatic chlamydia should it eventually come to market.

Big Surge Forecast
Forecasting data projects a big surge in POC testing. Kalorama Information, the Rockville, Md.-based research firm, projects 6 percent year-over-year growth for much of the decade, outstripping growth in many of the world’s other developed countries.

Kalorama projects the POC market in the U.S. reaching $13.1 billion a year by 2018 (that includes over-the-counter assays, which are usually purchased by consumers to conduct testing at home). Demand for POC tests in developing countries such as India and China—where vast middle classes have sprung up in recent years with the means to afford health care services—has even much higher demand. According to the College of American Pathologsists (CAP), growth for some POC tests is as high as 30 percent a year.

Kalorama also noted that there has been an interest in the market for molecular POC testing, although the report observed that “platforms for molecular diagnostic POC testing need to be small, portable, potentially hand-held, easy-to-use, and inexpensive. They need to be fully automated from sample to answer, so that they can be used by individuals who are not highly trained in molecular diagnostics or in laboratory testing in general.” And such tests would also require CLIA waivers as well.

Nevertheless, Kalorama noted that between 2009 and 2013, companies that are developing molecular POC or “near patient” tests have raised more than $650 million from investors and financings.

Some Disadvantages
Despite the fact that POC testing will almost certainly enjoy dramatic growth in the coming years, disadvantages to performing such tests compared to traditional laboratory testing remain.

According to a recent CAP report, “questionable quality can occur” when performing POC assays, “given the variety of educational and experience levels and turnover of staff that perform the tests.” There is a risk that testing can be inadvertently performed on the wrong kinds of specimens (such as performing guaiac testing on nipple secretions instead of feces).

And even if a test is granted a CLIA waiver there is no guarantee that it is foolproof when conducted away from a traditional laboratory setting. “Simplicity is deceptive and there are many ways that staff can inadvertently generate a wrong result,” the CAP said in its report, concluding that “just because it exists does not mean POC testing should be used in all situations. The need for comparability with central laboratory testing, efficacy, operational device and kit failsafes, management and oversight requirements, operator performance standards, economic indicators, and patient outcome data are all now considerations.”

Takeaway: Improvements in technology and shifting health care markets means point-of-care testing is expected to grow significantly in the coming years.