The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement marks a significant reversal from the previous positions of the Obama administration, FDA, and specifically, Dr. Jeffrey Shuren, Director of the FDA Center for Devices and Radiological Health (CDRH).
Background
LDTs were historically regulated not by the FDA, but rather by the Centers for Medicare & Medicaid Services (“CMS”) under the Clinical Laboratory Improvement Amendments. LDTs were initially simple lab tests and were often used either for rare conditions, for which a conclusive test result could not be guaranteed, or for very well-understood diseases; thus, they played a low-risk role in a patient’s overall healthcare decisions.
Growing concerns with LDTs
According to the FDA, it became concerned with the safety and efficacy of LDTs as the tests became increasingly more complex. LDTs also started playing a more prominent role in patients’ clinical choices, especially in the area of personalized medicine through genetic testing, despite the possibility of inaccuracies in the test results. Because of the risk of unproven and inaccurate information that LDTs might provide, the FDA viewed unregulated LDTs as risky for both healthcare providers and patients, who would then rely on the LDT results for further health recommendations and strategy. As a result, in 2014, the FDA issued draft guidance stating its intention to regulate LDTs as other in vitro diagnostics, including through registration, adverse event reporting, and premarket review processes.
Future of LDT oversight
FDA spokeswoman Tara Goodin explained on November 18, 2016 that the agency continues to believe that oversight of LDTs is necessary to produce accurate test results, but that the agency will seek further input from the Trump administration and Congress in developing any regulation. Trade associations, such as the American Clinical Laboratory Association, widely feared the LDT regulations would stifle innovation in the diagnostic test arena and thus viewed the decision as a victory for the clinical laboratory industry. Further, despite FDA’s position to the contrary, stakeholder groups maintained that the FDA could not regulate LDTs as medical devices because LDTs differed from other medical devices that fell under FDA’s purview.
Industry must, however, remain cognizant of the possibility of future regulations concerning LDTs, as this was not ruled out by the FDA. We will monitor future developments and will post again if anything changes.
