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regulatory approval

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared BioFire Diagnostics' FilmArray Blood Culture Identification, or BCID, Panel, the company announced today.

NEW YORK (GenomeWeb News) – CombiMatrix said today that its chromosomal microarray test for miscarriage analysis has received conditional approval from the New York State's Department of Health, allowing the company to begin testing patient samples from the state.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Abbott's hepatitis C virus genotyping test for marketing in the US, the company said today.

NEW YORK (GenomeWeb News) – Roche announced today that the Canadian Health Authority has accepted the use of its mycoplasma detection tool for "release testing" of one of the firm's undisclosed biological products.

NEW YORK (GenomeWeb News) – The Medical Device Bureau of Health Canada has granted a license to Abbott to market its RealTime High Risk HPV molecular diagnostic test for detecting human papillomavirus, Abbott announced today.

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Roche's companion diagnostic test for Tarceva (erlotinib), Roche announced Tuesday night.

NEW YORK (GenomeWeb News) – Cancer Genetics said today it has received CLIA and New York approval to offer its microarray-based kidney cancer test.

NEW YORK (GenomeWeb News) –Amoy Diagnostics today said that China's State Food and Drug Administration has approved the company's EML4-ALK Fusion Gene Detection Kit for marketing in that country.

NEW YORK (GenomeWeb News) – Pharmacogenomics firm Genomas today announced it has obtained clinical laboratory licenses from New York, Florida, and California.

NEW YORK (GenomeWeb News) – Chinese regulators approved Veridex's CellSearch circulating tumor test for aiding in the diagnosis of women with metastatic breast cancer, Veridex announced on Wednesday.

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Public health experts call for a transparent COVID-19 vaccine approval process in a letter; the Food and Drug Administration commissioner assures science-based approval.

The Verge reports that new gene-naming guidelines aim in part to avoid Excel-related name change confusion.

In Nature this week: tuatara genome sequence aids in understanding amniote evolution, and more.

According to the Guardian, UK virologists say in a letter to officials that their expertise has been pushed aside in COVID-19 response plans.