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The Life Sciences business grew 10 percent year over year, while the Diagnostics business inched up 1 percent.

Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.

The diagnostic can now be used to identify a wider range of patients with stage III or metastatic NSCLC who may benefit from first-line treatment with Keytruda.

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.

For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.

Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.

The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.

The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.

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