FDA warning letter | GenomeWeb

FDA warning letter

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.

Three new companies have received letters from FDA stating that their tests make medical claims and appear to fall under device regulations.

The company continues to leverage its patient database of cohorts to conduct research into genetic factors in disease, the predictive power of its tests, and how consumers are using information gleaned from their test results, a company official said today.

Sequenom said in an SEC document that its SensiGene test, which the company believes was cited by the FDA for being improperly marketed without FDA approval, is an LDT and meant "solely for use within our CLIA-certified and CAP-accredited laboratory."

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The Wall Street Journal reports that National Institutes of Health Director Francis Collins' response to contamination concerns at the agency might have delayed care.

The final revision of the Common Rule doesn't include the proposed change requiring consent for leftover biospecimens.

The first Reproducibility Project: Cancer Biology papers show mixed results.

In Nature this week: mobile phone-based targeted DNA sequencing, and more.