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pharmacogenomics

Regulators told the lab industry that they can continue to offer PGx lab tests without FDA approval if they make evidence-based claims.

The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.

The companies will join their respective technologies to provide pharmacogenomic information for patients undergoing genetic testing.

Consumers have filed complaints about the San Diego-based firm's questionable business practices and lack of response in the last year. 

The program aims to consent up to 150,000 patients to a larger biobank program and return selective preemptive PGx results through their medical center physicians.

The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.

The group wants the agency to allow labs to discuss gene-drug relationships with "adequate evidence" in test reports and hold a public meeting.

Spartan's test is for the rapid, near-patient determination of a cardiac patient's genotype for aid in determining appropriate antiplatelet treatment.

Despite the step-up in FDA action against labs offering PGx tests, the success of these programs suggests that access to them isn't being stifled as some feared.

While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

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