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.
The molecular test detects a form of herpes virus that can infect newborns and cause deafness.
The US Food and Drug Administration is developing a new approach for clearing medical devices to take technological advances and modern safety and performance requirements into account.
Invivoscribe submitted the LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Daiichi Sankyo's acute myeloid leukemia drug quizartinib.
The World Health Organization has announced the members of its gene-editing committee, according to NPR.
DARPA is working on developing algorithms that gauge the credibility of research findings, Wired reports.
The American Society of Breast Surgeons recommends all women diagnosed with breast cancer be offered genetic testing, the Washington Post says.
In Science this week: comparison of modern, historical rabbit exomes uncovers parallel evolution after myxoma virus exposure; and more.