Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
Researchers genotyped advanced cancer patients treated with immunotherapies and found that homozygosity at HLA loci was linked to decreased survival.
Memorial Sloan Kettering Cancer Center also hopes its partnership with analytics vendor Cota will help it prepare for value-based reimbursement.
The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."
Analytics vendor Cota will classify records from Memorial Sloan Kettering in hopes of improving cancer care and research.
Pathoquest will compare its iDtect blood test with standard testing methods to identify microbes causing infections in patients with febrile neutropenia.
Researchers will use the company's Colvera assay to track biomarkers in rectal cancer patients before, during, and after treatment.
In Cell this week: post-treatment changes to melanoma genome, multi-omics analysis of muscle-invasive bladder cancer, and more.
Researchers found that ADAR works by stabilizing the FAK gene, which is one of a subset involved in cell migration pathways.
In PLOS this week: preconception carrier screening program results, comparative genomics-based analysis of Elizabethkingia meningoseptica, and more.
Canadian regulators are beginning to share information from new drug studies, Undark reports.
In a column at the Dallas Morning News, the Stanley Medical Research Institute's E. Fuller Torrey says the Human Genome Project hasn't delivered on promised results.
Researchers explore a possible genetic cause for some cases of sudden infant death syndrome, KOMO News reports.