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pharmacogenomics

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.

According to the DOJ, the company also accepted a 25-year ban on participating in any federal healthcare program.

The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."

The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.

The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.

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