The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.
It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.
The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.
The Trump Administration has proposed a plan to reorganize the federal government, the Washington Post reports.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The FDA will consider the companion diagnostic application alongside data for Pfizer's talazoparib in BRCA-mutated advanced breast cancer.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
The Personalized Medicine Coalition defends the US Food and Drug Administration from criticism on its push to shorten the regulatory review process.
Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify cervical cancer patients who may benefit from the anti-PD1 immunotherapy.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
The Associated Press reports that a state board in Texas has asked ANDE, a maker of rapid DNA machines, to halt its work there.
James Wyngaarden, the former director of the US National Institutes of Health, has died at 94, according to Duke University School of Medicine.
Researchers find that a 30-year-old skull comes from a narwhal-beluga hybrid, according to Science News.
In Nature this week: study of value diversity in GWAS, Epstein-Barr virus subtypes linked to nasopharyngeal carcinoma risk, and more.