Logo

Genomic Health Comments on New FDA IVD Guidance

Sep 06, 2006

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News) — Genomic Health said today that it has provided initial comment on the US Food and Drug Administration's draft guidance on "In Vitro Diagnostic Multivariate Index Assays."
 
Randy Scott, Genomic Health’s chairman and CEO said in a statement that the “draft guidance represents the first public discussion surrounding the agency's thinking about the regulation of certain laboratory-developed tests."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.

Breaking News
The Scan

Study Points to Tuberculosis Protection by Gaucher Disease Mutation

A mutation linked to Gaucher disease in the Ashkenazi Jewish population appears to boost Mycobacterium tuberculosis resistance in a zebrafish model of the lysosomal storage condition, a new PNAS study finds.

SpliceVault Portal Provides Look at RNA Splicing Changes Linked to Genetic Variants

The portal, described in Nature Genetics, houses variant-related messenger RNA splicing insights drawn from RNA sequencing data in nearly 335,700 samples — a set known as the 300K-RNA resource.

Automated Sequencing Pipeline Appears to Allow Rapid SARS-CoV-2 Lineage Detection in Nevada Study

Researchers in the Journal of Molecular Diagnostics describe and assess a Clear Labs Dx automated workflow, sequencing, and bioinformatic analysis method for quickly identifying SARS-CoV-2 lineages.

UK Team Presents Genetic, Epigenetic Sequencing Method

Using enzymatic DNA preparation steps, researchers in Nature Biotechnology develop a strategy for sequencing DNA, along with 5-methylcytosine and 5-hydroxymethylcytosine, on existing sequencers.