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 FDA cleared two assays with samples collected during women's routine liquid-based Pap testing for cervical cancer screening.
The ProParaflu+ assay joins a line of tests Prodesse sells for diagnosing and differentiating respiratory viruses.
The FDA cleared an update to the package insert for its Verigene Respiratory Virus Nucleic Acid Test to include reactivity with Influenza A in cultured clinical isolates containing 2009 H1N1 influenza virus.
Roche becomes the latest of a handful of vendors to get an EUA from the FDA to sell its 2009 H1N1 flu assay to CLIA labs.
The guidance document is intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus, and provides information regarding filing for Emergency Use Authorization.
The FDA cleared the firm's microarray-based multiplex platform and a rheumatoid arthritis test that runs on the system.
The FDA cleared analytical reactivity information to be added to a package insert for the firm's RAMP Influenza A/B Assay.
The Wall Street Journal looks into FamilyTreeDNA's handling of genetic genealogy searches by law enforcement.
In a point-counterpoint in the Boston Globe, researchers discuss the potential of gene editing to prevent Lyme disease, but also the pitfalls of doing so.
MIT's Technology Review reports that researchers hope to develop a CRISPR-based pain therapy.
In Science this week: atlas of malaria parasites' gene expression across their life cycles, and more.