There has been a lot of whoop-ti-do about when the FDA will close enforcement discretion loopholes in regulations governing Laboratory Developed Tests. The FDA claims it has the authority, just hasn’t gotten around to rule making since 2006. CLIA and CAP regulations putatively cover these tests. Private health care payers and Medicare already reimburse for many of these tests under existing CPT codes. And the American Clinical Laboratory Association suggests that HR 3207 now making its way through Congress will do a better job at monitoring and controlling these tests than the FDA.
I’d like to put this controversy in perspective from the point of view of a bio-entrepreneur eager to create value at the bench in life sciences, emulating the success of the garage computer tinkerers who gave us PCs, mobile Apps, Apple, and incredibly clever software solutions. Laboratory Developed Tests offer the bio-tinkerer a path to implement innovations, provide medical value, and generate wealth, unencumbered by bureaucratic obstacles.
Licensed physicians decide the relevancy of test results in their professional exchanges. Just as physicians have the right to prescribe drugs off label, they should have the right to review results of research and decide for themselves if this information helps them manage their patients.
Lab Developed Tests are developed internally at a laboratory whose use is confined to the same laboratory that develops the test. That is, until the test catches on. These tests are developed to answer an unmet medical need for monitoring, prognosis, or diagnosis of a disease condition. Their development is driven by an unmet medical need, a recognition of a biological relationship that, if measured, is informative, and by the ability to implement such a test in a lab setting when commercially available tests aren’t available.
Tropoinin for acute coronary syndrome, hsCRP for Heart Disease, staining protocols, ESR rates, genetic tests for rare diseases, Pap smears are all examples of Lab Developed Tests used either in the hospital or in pathology evaluations. What sounds trivial is in fact a big deal. LDT test revenues are the fastest growing segment of the commercial reference laboratory testing market.
There are over 7 billion lab tests performed in the US each year. Total revenues exceed $52 billion a year over the last few years. More than 1400 tests are offered by more than 95 different laboratories.
Lab developed tests offer clinical diagnostic test developers a quicker go to market path than the traditional FDA 510(k) or PMA approval routes. After establishing their relevance during ‘proof of concept’ that lead to more wide spread acceptance, such tests could be commercialized using the traditional pathways.
Why throw a monkey wrench in the works now?
Why restrict innovation in an arena occupied by licensed physicians? Why interfere with the pathologist/clinician/patient relationship when generating information that could be useful for managing a patient?
Most importantly, why interfere with the development of potentially disruptive breakthroughs that will drag medicine, kicking and screaming, forward? With the shortfalls in federal spending for research, the high cost of drug and medical device development, the plethora of new technologies, availability of information, and existence of talent, why not let creative people be rewarded for generating creative solutions to unmet medical needs?