The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
With the accreditation, the La Jolla, California-based molecular dermatology firm can provide its services in all 50 states and the District of Columbia.
Designed to run on the company's Sentosa real-time PCR system, the test has been approved for identifying and differentiating Zika in patients.
The PCR-based cartridge is designed to detect 21 pneumonia pathogens and 19 genetic markers of antibiotic resistance, and runs on the company's Unyvero system.
A new report from the Personalized Medicine Coalition highlights new personalized medicines approvals by the US Food and Drug Administration.
The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.
The genetic testing firm can now offer its Prelude noninvasive prenatal test to residents in New York State.
Myriad Genetics' BRACAnalysis CDx can identify which metastatic patients have BRCA mutations and would likely benefit from treatment with AstraZeneca's Lynparza.
The Sentosa SX101 instrument has been approved by the Taiwan Food and Drug Agency for in vitro diagnostic use.
NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.
According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.
A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.
In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.