The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Plans are in place for a Guardant360-based assay to predict response to AsztraZeneca's Tagrisso and for a blood-based TMB test using the larger GuardantOmni panel.
ScienceInsider reports that US National Institutes of Health researchers were told in the fall they could not obtain new human fetal tissue.
The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
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 US Department of Health and Human Services says it has not cancelled a fetal tissue contract with a University of California, San Francisco, lab, Science reports.
The endorsement is the agency's first through the Human Variant Database Program, for which it released final guidance earlier this year.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
NPR says a new US Government Accountability Office report criticizes the Food and Drug Administration's orphan drug program.
The effort is one of five being undertaken by MDIC's Clinical Diagnostic Program designed to expedite the regulatory process for clinical diagnostics.
According to New Scientist, GEDmatch changed its terms and conditions over the weekend to opt its users out of law enforcement searches.
The Atlantic looks into time spent pursuing gene leads generated through candidate gene studies.
A twin study uncovers evidence that genes may influence whether someone gets a dog, Martha Stewart reports.
In PNAS this week: Cdx2 cells can help regenerate heart tissue in mice following a heart attack, PIWI-interacting small RNA levels in human cancer, and more.