The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.
Qiagen's test detects the most frequently occurring somatic mutations in EGFR in less than four hours using real-time PCR on the Rotor-Gene Q platform.
The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.
The test combines qPCR and microarray technology to detect carbapenemase-producing enterobacteriaceae, a bacteria resistance to carbapenem antibiotics.
Upon clearance of the platform, the company will commercialize the TruDiagnosis, an IVD system for genotyping multiple genes in a DNA sample, this year.
Chinese state news agency Xinhua reports that a preliminary investigation has found He Jiankui performed his gene-editing work illegally.
John Mendelsohn, a former president of the University of Texas MD Anderson Cancer Center, has died, the New York Times reports.
Identical twins receive different estimates of ancestry from the same direct-to-consumer genetic testing firms, CBC reports.
In PNAS this week: chromosomal features of maize, adaptations in the vinous-throated parrotbill, and more.