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FDA warning letter

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.

The firm's life science segment grew revenues 8 percent, but revenues from its diagnostics segment saw revenues retreated 4 percent. 

DNA4Life's product is marketed to patients to predict how they will respond to more than 120 of the most commonly prescribed medications.

The letter informed the firm that its production of Xpert Norovirus assays at the Solna, Sweden site does not conform to good manufacturing practice requirements.

The FDA issued a close-out letter to the Agilent subsidiary saying Dako appears to have addressed violations dating back to two years ago. 

NEW YORK (GenomeWeb News) – Direct-to-consumer testing firm 23andMe has decided to comply with the US Food and Drug Administration's wishes and discontinue providing health-related genetic data interpretation services to new customers.

NEW YORK (GenomeWeb News) – Atossa Genetics on Friday voluntarily recalled its ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology (MASCT) Test device from the market in the wake of concerns raised by the US Food and Drug Administration.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration issued a warning letter to Agilent Technologies' Dako business, saying the company's HER2 chromogenic in situ hybridization, or CISH, pharmDx test and other products do not conform to federal current good manufacturing pract

By a GenomeWeb staff reporter NEW YORK (GenomeWeb News) – Beckman Coulter's president has issued a letter to employees informing them that 8 percent of the company's workforce will be laid off as part of the company's restructuring.

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The New York Times Magazine examines gender discrimination at the Salk Institute.

Science reports that MD Anderson Cancer Center has dismissed three researchers over foreign tie concerns.

A second death in gene therapy trial for type 1 spinal muscular atrophy is under investigation, according to Reuters.

In PLOS this week: antibiotic resistance patterns in Escherichia coli, a dozen genetic loci tied to varicose vein risk, and more.