Genetics & Genomics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

Noridian GBA has issued the LCD for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low-risk prostate cancer.

The test detects and quantifies hepatitis C virus RNA and can be performed in approximately one hour. 

The QuantideX NGS DNA Hotspot 21 kit is designed for use on the Illumina MiSeq platform and screens for 21 common genomic variants across a variety of cancers.


Illumina can now sell the instrument in China for IVD purposes. The firm said that the system is its first CNDA-cleared NGS platform in China.

The protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing.

Researchers hope to tease out the signature effects that different carcinogens leave on the genome to determine their contributions to disease, Mosaic reports.

The Wall Street Journal looks into the cost of new gene therapies.

In PNAS this week: genomic effects of silver fox domestication, limited effect of mitochondrial mutations on aging in fruit flies, and more.

An Australian-led team has generated a draft genome assembly of the invasive cane toad in hopes it will help in population control, the Sydney Morning Herald reports.