The project, which is an initiative of the Quest Diagnostics Foundation, aims to expand healthcare access in the area, including through no-cost laboratory testing.

The guidelines address items like interpretation of results that may be affected by gender-affirming hormone therapy and improving electronic health record practices.

The agency cleared more than a dozen assays and instruments for microbiology, molecular biology, clinical chemistry, and other testing.

The PCR-based panels detect up to 22 of the most common bacteria, viruses, and parasites associated with gastroenteritis.

The company aims to complete the international development and validation of the test, as well as to obtain European regulatory approval and commercialize it as a service and a kit.

The company will conduct a prospective, multicenter study enrolling approximately 954 men with elevated PSA levels who are scheduled for a prostate biopsy.

Last week, readers were most interested in a story about Achieve Diagnostics buying the pharmacogenomic assets of H&M Molecular Diagnostics.

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