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FDA Letter to Roche Questions Marketing AmpliChip as an ASR

NEW YORK, July 10 - The US Food and Drug Administration has sent a letter to the general manager of Roche Diagnostics, in Pleasanton, Calif., to discuss the appropriateness of Roche's marketing of its microarray-based AmpliChip as an analyte specific reagent (ASR) in the US, GenomeWeb has learned.

 

The AmpliChip, launched in June, was designed by Roche and manufactured by Affymetrix. It is based on cytochrome P450 liver enzymes.

 

The letter invites the Roche general manager to the FDA offices to talk about this matter. For the full story, see BioArray News and SNPtech Reporter.

The Scan

And Back

The New York Times reports that missing SARS-CoV-2 genome sequences are back in a different database.

Lacks Family Hires Attorney

A lawyer for the family of Henrietta Lacks plans to seek compensation from pharmaceutical companies that have used her cancer cells in product development, the Baltimore Sun reports.

For the Unknown

The Associated Press reports that family members are calling on the US military to use new DNA analysis techniques to identify unknown sailors and Marines who were on the USS Arizona.

PLOS Papers on Congenital Heart Disease, COVID-19 Infection Host MicroRNAs, Multiple Malformation Mutations

In PLOS this week: new genes linked to congenital heart disease, microRNAs with altered expression in COVID-19, and more.