Flatlander schreef op 6 december 2019 22:55:
Foundation Med recalls MSI assay tests due to MSI high false positives. Good time to have a cheaper faster product on the market. Good time to get expanded FDA marketing approval.
In Brief This Week: Foundation Medicine, PerkinElmer, Enzo Biochem, and More
Dec 06, 2019 | staff reporter
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NEW YORK – Foundation Medicine has recalled a number of its FoundationOne CDx tests because they contained a potentially false-positive microsatellite instability (MSI)-high result, according to a recent entry in the US Food and Drug Administration's Medical Device Recalls database. The company voluntarily initiated the recall in August, informing physicians by phone that they may have received an incorrect MSI-high result in their report and asking them not to use this result to prescribe treatment. All physicians said that no treatment plan utilizing the MSI result had been applied, according to the entry, and eight reports were affected in total. According to Foundation Medicine, the issue came to light during a routine review of sequencing data and the reports were recalled within 24 hours. The eight cases were part of more than 90,000 total cases, of which more than 1,800 had true MSI-high results.