The FDA warned Inova Genomics Lab for marketing pharmacogenomic and whole gene sequencing tests without the agency’s approval or clearance.
The Falls Church, Virginia lab marketed MediMap Tests on its website as genetic tests used for predicting a patient’s response to medications. The lab also said the tests could be used to determine what medicine and dose patients should take.
The FDA questioned the tests’ clinical validity, saying it was “unaware of data establishing the relationships between the genotypes assessed…and assertions regarding drug response for multiple drugs.”
The agency said the tests posed “significant public health concerns” because of their potential inaccuracy, which could misinform patients and healthcare providers about increasing, decreasing or stopping medication. For example, the abrupt cessation of antidepressants could cause illness, injury or death in patients due to withdrawal symptoms, the agency said.
The lab argued that the MediMap tests were laboratory developed tests (LDTs) that qualify for agency LDT exemptions, thus sparing them from premarket review or labelling requirements. But the agency saw things differently.
“FDA has not created a legal ‘carve-out’ for LDTs such that they are not required to comply with the requirements…that otherwise would apply,” the agency said. “Although FDA has generally exercised enforcement discretion for LDTs, [it] retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns.”
The agency threatened regulatory action without further notice if the lab failed to promptly deal with the violations. The lab has since removed the products from its website.
Read the full Inova Genomics Lab warning letter here: www.fdanews.com/04-08-19-InovaGenomicsLab.pdf. — James Miessler