South Korean FDA | GenomeWeb

South Korean FDA

The approval comes about five months after the RT-PCR-based kit, which also detects Dengue and Chikungunya, received CE-IVD marking.

The US Food and Drug Administration has already granted EUA to the test, which detects viral RNA in serum and urine.

NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services has issued a final National Coverage Determination (NCD) for Exact Sciences' stool DNA colorectal screening test Cologuard, and has agreed with the company's proposal to reimburse testing at $502.

Australian diagnostics firm HealthLinx said that preliminary data from a Korean Food and Drug Administration study of its ovarian cancer diagnostic OvPlex showed that the test offers an advantage over use of CA125 alone – currently the standard biomarker test used in ovarian canc

In PLOS this week: nasal microbial communities in asthma patients; sequencing-based way to detect, track schistosomiasis; and more.

The New York Times speaks with Vanderbilt's John Anthony Capra about Neanderthal genes in modern humans.

A draft guidance from the FDA suggests the agency wants to more tightly control gene-edited animals, according to Technology Review.

Researchers were among this weekend's protesters bemoaning the new US administration, Vox reports.