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Regulatory Focus™ > News Articles > 2019 > 4 > FDA Warns Genetic Testing Lab in Virginia

FDA Warns Genetic Testing Lab in Virginia

Posted 05 April 2019 | By Zachary Brennan 

FDA Warns Genetic Testing Lab in Virginia

The US Food and Drug Administration (FDA) on Thursday sent a warning letter to Falls Church, VA-based Inova Genomics Laboratory, raising concerns about the clinical validity of several genetic tests offered by the lab.

Inova markets genetic tests for “predicting medication response, reducing negative side effects from certain medications, discovering the right drug and right dose for a patient, and avoiding trial-and-error prescribing by healthcare providers by testing patient receptivity to drugs that treat specific conditions,” according to FDA.

“FDA is concerned that the clinical validity of your MediMap tests has not been established for their intended uses. Specifically, we are unaware of data establishing the relationships between the genotypes assessed by your tests and your assertions regarding drug response for multiple drugs. For example, the relationship between CYP2C19 genotype and drug response to escitalopram and sertraline is not established and this relationship is not described in the FDA- approved labeling for these drugs,” the letter says.

The agency also said the tests pose significant public health concerns as inaccurate results could impact the decision-making of health care providers and patients “in ways that are seriously detrimental to patient health.”

LDT Exemption?

Inova also declined to make certain changes FDA requested following a March 2019 teleconference. More specifically, FDA asked Inova to change the MediMap tests and labeling to address the concerns, “including removing from the labeling (e.g., patient test reports and promotional material) claims regarding drug responses for specific medications unless and until FDA reviews the information submitted to support such claims and grants marketing authorization.”

Inova also told FDA that the MediMap tests should be considered laboratory developed tests (LDTs) and that it is “properly operating within the scope of FDA’s LDT exemption and thus is not subject to FDA’s premarket review or labeling requirements.”

But FDA clarifies that it “has not created a legal ‘carve-out’ for LDTs…FDA has never established such an exemption. As a matter of practice, FDA, however, has exercised enforcement discretion for LDTs, which means that FDA has generally not enforced the premarket review and other FDA legal requirements that do apply to LDTs. Although FDA has generally exercised enforcement discretion for LDTs, the Agency always retains discretion to take action when appropriate, such as when it is appropriate to address significant public health concerns.”

Inova did not respond to a request for comment.

Warning Letter


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