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.
The firm recently won $4.5 million as well as approval for its Fertilome test from New York state, though some have questioned the test's clinical utility.
The test, which also is FDA-approved, can be used to identify best responders to three non-small cell lung cancer treatment regimens.
Pricing for FoundationOne CDx, which received FDA approval and a proposed CMS national coverage determination yesterday, will be determined under PAMA.
The FDA approved FoundationOne CDx and the Centers for Medicare and Medicaid Services concurrently issued a proposed national coverage decision for the test.
The test is designed to detect 14 of the most prevalent mutations in the gene responsible for the disease.
The wide-ranging discussion with witnesses from Stanford, Johns Hopkins, and Editas Medicine touched on recent advances in research and questions of safety.
23andMe is offering early customers re-testing on newer chips for a fee, Wired reports.
He Jiankui is no longer affiliated with Direct Genomics Biotechnology, the single molecule sequencing company he founded, Nikkei Asian Review reports.
Newsweek writes about the hopes for precision medicine in cancer, but also challenges getting it to patients.
In Genome Research this week: genomic architecture of glioblastoma, predictive computational approach to estimate SNP fitness, and more.