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 test combines the superior performance of laboratory-based PCR tests and the simplicity and convenience of traditional POC rapid immunoassays, the firm said.
The agency anticipates that the new pathway will promote comparisons with modern products rather than relying on older predicates.
A New Zealand minister says the country's genetic modification laws need to be re-examined to help combat climate change, the New Zealand Herald reports.
A new analysis finds some cancers receive more nonprofit dollars than others.
An Australian mother's conviction in the deaths of her children may be re-examined after finding that two of the children carried a cardiac arrhythmia-linked gene variant.
In Science this week: comparative analysis of sex differences in mammal gene expression, and more.