The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
The firm said that the Resistance GC assay will allow doctors to treat up to 70 percent of infected patients with a single dose of ciprofloxacin.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
The endorsement is the agency's first through the Human Variant Database Program, for which it released final guidance earlier this year.
A genome-wide association study highlights a potential role for hair follicles in acne risk, according to New Scientist.
Newsday reports that breast cancer genetic testing guidelines for are out of date and may miss individuals.
In Cell this week: gene editing-based strategy to screen for immune system regulators, ancient plague patterns, and more.
Publication of He Jiankui's work on gene-edited infants would raise ethical concerns for journals, Wired and others report.