Skip to main content
Premium Trial:

Request an Annual Quote

Genomic Health Comments on New FDA IVD Guidance


NEW YORK (GenomeWeb News) — Genomic Health said today that it has provided initial comment on the US Food and Drug Administration's draft guidance on "In Vitro Diagnostic Multivariate Index Assays."
 
Randy Scott, Genomic Health’s chairman and CEO said in a statement that the “draft guidance represents the first public discussion surrounding the agency's thinking about the regulation of certain laboratory-developed tests."
 
Genomic Health “plans to continue its ongoing dialogue with FDA regarding Oncotype Dx,” the firm’s RT-PCR-based breast cancer prognostic, which the company said went through multiple clinical trials among 2,600 patients.
 
Genomic Health has offered Oncotype Dx as a service through its CLIA-approved lab in Redwood City, Calif since 2004.

The Scan

More Boosters for US

Following US Food and Drug Administration authorization, the Centers for Disease Control and Prevention has endorsed booster doses of the Moderna and Johnson & Johnson SARS-CoV-2 vaccines, the Washington Post writes.

From a Pig

A genetically modified pig kidney was transplanted into a human without triggering an immune response, Reuters reports.

For Privacy's Sake

Wired reports that more US states are passing genetic privacy laws.

Science Paper on How Poaching Drove Evolution in African Elephants

In Science this week: poaching has led to the rapid evolution of tuskless African elephants.