Dive Brief:

• FDA Thursday sent a warning letter to Virginia-based Inova Genomics Laboratory for offering a series of genetic tests without marketing clearances or approval. The regulatory agency said relying on such tests could seriously harm patients if the results are used to select medications for treatment. 
• The series of tests Inova was marketing claimed to predict individual patients' response to specific drugs, without data reviewed by FDA to support such claims, the agency said. Specifically, the tests claimed to establish response for certain antidepressants, opioids, cancer treatments, anesthesia and diabetes medications, according to the warning letter.
• Inova claims the pharmacogenetic tests are laboratory developed tests exempted from FDA oversight, but the agency's warning letter said its practice of enforcement discretion for LDTs does not preclude it from taking action when it believes public health is at risk.

Dive Insight:

The warning letter to Inova follows a safety communication published by FDA in November 2018 informing doctors of several genetic tests making unapproved claims about an individual's response to a specific medication. 

"For example, the FDA is aware of genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the relationship between DNA variations and the effectiveness of antidepressant medication has never been established," the safety communication said. 

FDA medical device director Jeff Shuren said that the rise of pharmacogenetics' popularity threatens patients with the "false promise" of more effective treatment if they are not properly evaluated for safety and effectiveness. 

"We are 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," Shuren said in a statement.

Inova improperly advertised its genetic tests on its website, according to the FDA warning letter. The agency notes that the MediMap tests being advertised could be ordered by a lab physician and directly given to patients.

"This could lead to patients inappropriately increasing, decreasing, or stopping their medication without their physician’s involvement, which poses significant risks to patient safety. For example, abrupt cessation of antidepressants (e.g., escitalopram, sertraline) could lead to (1) illness, injury, or death due to withdrawal symptoms, (2) relapse of depression, and (3) reduced effectiveness of the drug if the drug needs to be re-started with the patient," the warning letter states.

FDA first asked Inova about its concerns in a March 13 teleconference and asked for a response in writing by March 25 to a request for the lab to change the MediMap tests' labeling. But the agency said Inova's response argued the tests are laboratory developed tests that fall within "the scope of FDA's LDT exemption and thus is not subject to FDA's premarket review of label requirements." 

"FDA has not created a legal 'carve-out' for LDTs such that they are not required to comply with the requirements under the Act that otherwise would apply. FDA has never established such an exemption," the warning letter states.

FDA Commissioner Scott Gottlieb has been vocal in his last weeks at the agency in support of the Leading-edge In Vitro Clinical Test Development (VALID) Act, which would bring LDTs under more rigorous oversight. But it is unclear if Congress will take action soon: stakeholder comments on a recent draft bill were varied and other health legislation has taken priority for lawmakers.  

The agency asked Inova to respond within 15 days how it plans to address the concerns raised. If the lab does not take corrective action, FDA said additional enforcement actions may be taken including seizure of tests, injunctions and monetary penalties.  

FDA continues to warn the public about our concerns with pharmacogenetic tests whose claims have not been FDA reviewed. We are aware that these types of tests are promoted to predict how a person will respond to specific meds such as anti-depressants https://t.co/U6hh54imSJ

— Scott Gottlieb, M.D. (@SGottliebFDA) April 5, 2019