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"Cytogenetics is one of the first areas where there is interest to move beyond the current research studies, which will require an FDA cleared or approved product," said a Roche NimbleGen official.
The 510(k) clearance covers an AdvanDx protocol that speeds up identification of two fungal infections to 90 minutes.
The EUA for the company's RT-PCR Assay comes near the end of the declared public health emergency period, which is set to expire near the end of April, unless it is extended.
The C. difficile test is the first molecular diagnostic product for Meridian. It hopes to market the test later this year.
ArrayIt plans to seek FDA clearance for its pre-symptomatic ovarian cancer test based on its microarray platform.
The San Antonio-based firm also intends to file a 510(k) for clearance of the assay.
Cepheid became the latest firm to receive an EUA for its H1N1 flu assay, but said it is the first to receive the designation for CLIA moderate complexity labs.
The assay was developed through Affymetrix's MyGeneChip Custom Array Program. It is the latest in a series of molecular diagnostic products to get an FDA EUA.
Agendia said that it is the fourth FDA clearance for MammaPrint over the past three years.
The agency granted Emergency Use Authorization for the GeneSTAT diagnostic test.
The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.
In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.