Laboratory testing comprises a complex menu of assays, most of which are formulated as test kits from a vast array of in vitro diagnostic (IVD) manufacturers. However, IVD companies cannot meet the full need for testing patients with many types of diseases.

This is particularly true in the molecular diagnostics area where companies have been relatively slow to develop molecular-based platforms for certain infectious, genetic and oncologic diseases. These unmet needs have been filled by developing lab tests within the clinical laboratory.

Lab developed tests (LDTs) require extensive development time to ensure excellent test performance (for example, sensitivity, accuracy, precision, and many other aspects). Over the past year or so, LDTs and government oversight of these tests have received much attention by the pathology community as well as in the lay press. This new attention to LDT regulation has been the result of potential new oversight of LDTs by the Food and Drug Administration and there have been many hearings on the subject in Washington. We as experts, as well as others, have expressed our concerns about the new regulations to federal regulators.

Recently, I read with interest an article by Thomas Burton in the December 10 issue of the Wall Street Journal, “Is Lab Testing the ‘Wild West’ of Medicine? Largely unregulated industry comes under FDA scrutiny; lab-developed test providers fight back on lab developed tests.”

The article implied that we exist in an unregulated environment. To the contrary, we—in fact, all clinical labs—are highly regulated. Clinical laboratories are licensed by the federal government Centers for Medicare & Medicaid Services (CMS) to perform testing under the Clinical Laboratory Improvement Acts, also known as CLIA.

The article does not mention CLIA regulations and the fact that these extensive regulations cover all lab tests, including LDTs. I would submit, however, that CLIA was written at a time before we had more complex testing to fill the need for the emerging areas of personalized medicine.

As such, what is really needed is congressional action to modernize CLIA regulations to fill in the gaps to ensure LDT quality, rather than having the FDA impose new and unrealistic regulations on top of CLIA requirements. To point: the majority of commercial test kits cleared by the FDA for sale to clinical labs go through a 510(k) review, and many provide neither sensitive nor specific results, nor are they required to do so.

FDA clearance of LDTs, therefore, will not necessarily have the desired effect and only add significant cost to an already expensive and overburdened health care system, and impose additional regulations on laboratories that are already covered by existing, although not perfect government regulations.
 

Irving Nachamkin, DrPH, MPH, D(ABMM), FAAM, FIDSA, is the Director of the William Pepper Laboratory and the Division of Laboratory Medicine at Penn Medicine.

Disclaimer: The views and opinions expressed in this blog column are those of the authors or other attributed individuals and do not necessarily represent the official position of the Department, Penn Medicine, or the University of Pennsylvania. Health information is provided for educational purposes and should not be used as a source of medical advice or diagnosis.

(Image: U.S. Food Administration, Educational Division - Series: WWI posters, 1918. Source: National Archives)

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