Skip to main content

Gene Logic Grants FDA Access to Data and Software for PGx Evaluation

NEW YORK (GenomeWeb News) – Gene Logic today said it will give the US Food and Drug Administration access to certain of its genomics data and software to help the agency evaluate voluntary genomics data submissions.
 
As part of the deal, the FDA will get access to a collection of toxicogenomic and rat classical toxicology data from Gene Logic’s ToxExpress system; gene expression data from normal human tissue samples from its BioExpress system; its Genesis Enterprise System 3.0 software for data management and analysis; and the GX Connect 3.0 software for uploading third-party data into the Genesis Enterprise System.
 
The FDA’s VGDS program, outlined in its March 2005 Pharmacogenomics Guidance Document, is aimed at encouraging drug makers to voluntarily submit genomics data to help edify the FDA about the kinds of technologies and methodologies these companies use in pharmacogenomics research.

The Scan

Gap in COVAX Doses

BBC News reports that COVAX is experiencing a vaccine shortfall, as the Serum Institute of India has paused exports.

Sanofi, GSK Report Promising Results

The Wall Street Journal reports that the candidate SARS-CoV-2 vaccine from Sanofi and GlaxoSmithKline has had encouraging early results.

Influence of Luck

The New York Times examines how the US avoided variant-fueled increases in COVID-19 cases.

PLOS Papers on Retina GWAS, Hantaan Virus, COVID-19 Phenome-Wide Association Study

In PLOS this week: genome-wide association study of retinal morphology, analysis of hantaan virus found in a mouse, and more.