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Expression Analysis Claims GLP Compliance for Affy Services

NEW YORK, May 25 (GenomeWeb News) - Microarray service provider Expression Analysis said today that it has met all requirements for compliance with the Food and Drug Administration's good laboratory practice regulations.

 

The company said it took two years to develop and implement standard operating procedures, equipment and process validations, training, internal audits, and document control measures to meet the FDA's 21 CFR Part 58 guidelines for nonclinical laboratory studies.

 

According to Expression Analysis, it is now "the first company capable of providing Affymetrix GeneChip processes performed in compliance with GLP regulations."

 

Expression Analysis has already collaborated with the FDA as part of the agency's effort to standardize microarray data used in regulatory submissions. Steve McPhail, Expression Analysis' CEO, said in a statement that GLP compliance was "a logical next step" for the Durham, NC-based firm.

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.