FDA warning letter

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.

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.

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Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.

A new report has found that researchers in Africa are still heavily dependent on funding from organizations in the US, Europe, and China, Nature News says.

An article in The Atlantic argues that the progress being made in science isn't keeping pace with the money and time being spent on research.

In Science this week: a CRISPR screen identifies sideroflexin 1 as a requisite component of one-carbon metabolism, and more.