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.
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.
A new analysis examines the gender gap among paper authors in the sciences and says it may take decades or more to close.
Researchers have uncovered signals of selection that may enable the Bajau people to free five hundreds of feet deep, Reuters reports.
In Science this week: paternally inherited cis-regulatory structural variants in autism, and more.
A new report outlines issues facing the implementation of personalized medicine in the UK, the Independent reports.