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.
The test, which also is FDA-approved, can be used to identify best responders to three non-small cell lung cancer treatment regimens.
The former commissioner of the FDA has returned to the venture capital firm New Enterprise Associates as a special partner on the healthcare investment team.
Astronauts have edited yeast genes on the International Space Station in an experiment designed to show how cells repair themselves in space.
Emory University has found that two of its researchers failed to divulge they had received funds from China, according to the Atlanta Journal-Constitution.
In Science this week: influence of the nuclear genome on human mitochondrial DNA, and more.