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: role for Notch signaling in congenital heart disease, sciatica risk variants, and more.

Researchers in China have used the CRISPR/Cas9 genome editing approach to alter the length of hair fibers in cashmere goats.

According to ScienceInsider, the Scripps Research Institute and the California Institute for Biomedical Research are merging.

National Cancer Institute researchers didn't report severe adverse events to Food and Drug Administration in a timely manner, the Wall Street Journal reports.