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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

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.