South Korean FDA

The assay is based on real-time reverse transcriptase PCR that will identify Zika in human serum or urine. 

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

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

Researchers find that a personalized medicine approach could help people who experience pain while taking statins, New Scientist reports.

US National Science Foundation is continuing its responsible research conduct training policy despite its flaws, ScienceInsider reports.

A CRISPR-themed meeting explored how the tool could and should be used, Wired reports.

In Science this week: database of proteins' effects on cancer, targeted error correction sequencing, and more.