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NEW YORK (GenomeWeb) – Myriad Genetics said it has submitted the first module of its premarket approval application for myChoice HRD CDx with the US Food and Drug Administration.

The firm is seeking approval of myChoice HRD as a test that can identify patients with ovarian, fallopian, or peritoneal cancer whose tumors are deficient in homologous recombination DNA repair, regardless of their BRCA mutation status, and may benefit from treatment with GlaxoSmithKline's niraparib (Zejula) as a fourth-line option.

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UK Royal Statistical Society is organizing a working group to develop guidelines for assessing COVID-19 tests, the Guardian reports.

The Washington Post reports that the White House chief of staff has asked the US Food and Drug Administration to justify the stricter standards it is seeking for a coronavirus vaccine.

President Donald Trump's "good genes" comment raises eugenics concerns, CNN reports.

In PLOS this week: genetic analysis of tremor condition, analysis of a West and Central African tree used in traditional medicine, and more.

Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.