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Medical Devices / Inspections and Audits

Inova Genomics Lab Warned for Selling Genetic Tests Without Agency’s OK

April 8, 2019

The FDA has 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.

However, the FDA expressed concerns about their clinical validity, noting that it was “unaware of data establishing the relationships between the genotypes assessed…and assertions regarding drug response for multiple drugs.” The agency ruled that the tests posed “significant public health concerns” over their potential inaccuracy.

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