Point of Care Testing Industry

Diagnostic Testing and Technology Report, 1999 Interview with Robert Bauer

Excerpts from an interview with Robert Bauer, President of CaseBauer (Irving, Texas), conducted on October 1, 1999 by Jon David Klipp, Editor of the Diagnostic Testing and Technology Report.

Point of Care Market Size and Growth

KLIPP: How big is the POCT market and how fast is it growing?

Robert Bauer: Point-of-care testing is 15% of the total IVD products market, about $3.3 billion, including hospitals, physician offices and patient self-testing products. We're projecting annual revenue growth to be in the 13% to 15% range. (Note: Worldwide number)

KLIPP: What is driving the growth of point-of-care testing?

ROBERT BAUER: In recent years, growth has been driven by an increase in the acceptance of point-of-care products that were introduced in the 1980's. A number of factors contribute to this - most notably outcomes studies, the institutionalization of procedures by managed care, and physician awareness. For example, when the Diabetes Control and Complications Trial (DCCT) was published in 1993, it sparked significant growth of glucose self-testing products - products that had been on the market for almost a decade. Motivated healthcare system began to provide infrastructure, such as patient training and monitoring, and education of physicians. Payers jumped on the bandwagon and provided incentives, such as HEDIS quality certification, which sets targets for increased testing.

Point-of-care testing opportunities can have long lag times, particularly those directly involving patients. It's an incredible task to educate and motivate 10 million diabetes patients, 100 thousand physicians, as well as the providers and insurers.

The Drive toward Centralized Laboratory Operations has Catalyzed the Value of Point-Of-Care Testing

KLIPP: In particular, what has been the point-of-care testing trend in hospitals?

ROBERT BAUER: Interestingly, the drive toward centralized laboratory operations has catalyzed the value of point-of-care testing in hospitals. Physicians in the emergency room used to be able to send samples two doors down to the hospital's laboratory. Now, with testing centralized in a core laboratory on the other side of town, point-of-care testing becomes a more viable option for a lot of time-sensitive tests. We have encountered laboratory directors in highly centralized laboratory systems supporting manual testing alternatives. Putting manual tests at the point-of-care allows them to retire instruments that have been maintained just to meet STAT testing needs.

Barriers to the Growth of Point of Care Testing - Technology, Clinical Utility, and Cost

KLIPP: What are the biggest barriers to the growth in point-of-care testing?

ROBERT BAUER: For patient self-testing, there are three common barriers. The first is technology, providing accurate tests that are reliable in the hands of unskilled users. Technology is improving but still requires, in many cases, periodic calibration and quality control procedures that are beyond the capability and interest of non-laboratory personnel.

The second is clinical utility. There must be a compelling motivation to test in the mind of the tester, whether this is a patient, a doctor, or a nurse, and there must be actions to take based on the test result. In the case of a pregnancy test, this is clear. You quickly decide to tell your husband, call planned parenthood, see your OB-Gyn, whatever. Action needs to be taken. With cholesterol, the motivation to test is lower, and the required action is pretty much see the doctor at your earliest convenience.

The third is costs. Laboratory directors and administrators hate to spend $10 for a point-of-care test they can run in the laboratory for $0.88. Payers have raised barriers to physician testing over the past decade, with some going as far as to specify laboratories for testing.

In the United states you can add a fourth barrier - CLIA operating protocols enforced by the CDC. Short-term, this won't get any better as the enforcement of CLIA is being transferred to the FDA.

The Diabetes Point-of-Care Testing Market is Growing the Fastest

KLIPP: Which segments of the point-of-care testing market are growing the fastest?

ROBERT BAUER: On an overall unit basis, diabetes. Glucose testing and related ancillary tests, comprise about 50% of the overall market for point-of-care testing.

KLIPP: How do you determine the costs and benefits of point-of-care testing?

Robert Bauer: It's not the direct savings of the testing such as specimen transport savings that provide the benefits, it is the larger and more difficult to quantify downstream costs. For example, if you're reducing the complications of deep vein thrombosis therapy by stabilizing patient clotting times more rapidly with a point-of-care test, the payback is significant and hospitals have the wherewithall to make the investment and reap the benefit. Hospital administrators are motivated to reduce ICU days that can cost as much as $3,000 per day. In the scheme of things, it really doesn't matter that it can be done $1 cheaper in a core lab.

At the same time, public health agencies would love a point-of-care test for chlamydia, but their ability to pay is much less, and the benefit is not directly realized by the public health entity that does the testing.

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