FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity

After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for “illegally marketing” its MediMap genetic tests for predicting a patient’s response to medication, specifically:

• MediMap Plus, which evaluates patient response to drugs treating, among other things, anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety and diabetes; and
• MediMap Baby, which analyzes a newborn’s genes that influence response to 24 medications.

The FDA contends that Inova’s website claimed that the tests provide “actionable and informational guidance” and that “[h]ealthcare providers can use these results confidently in making treatment decisions.” In its press release announcing the warning letter, the FDA commented that it “is unaware of any data establishing that Inova’s test can help patients or health care providers make appropriate treatment decisions for the listed drug.” The FDA stated that this warning letter “reflects the agency’s commitment to monitor the pharmacogenetics test landscape and take action when appropriate to address a significant public health risk.”

The Director of the FDA’s Center for Devices and Radiological Health explained that the FDA is “particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions.”

The 2 takeaways from the warning letter:

1. The FDA can and will take action against LDTs, particularly ones being marketed directly to consumers; and
2. If the physician who orders the test is affiliated with the lab, the physician order may not be enough to keep the agency from suspecting direct-to-consumer marketing.

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This article originally appeared in G2 Intelligence, Laboratory Industry Report, May 2019