A set of rules for IVDs will take effect in 2022, and another for medical devices will take effect in 2020.
The test is approved as a tool to identify which patients with a kind of ovarian cancer are likely to benefit most from Tesaro's Zejula (niraparib).
The oncology assay is the first from Roche using either plasma or tumor tissue samples and identifies 42 mutations in the EGFR gene.
In a speech to Congress, President Donald Trump called the drug approval process at FDA "slow and burdensome."
The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.
Reuters reports that drug approvals in the US are at a low, but that might reflect a return to previous activity levels.
The company can now offer its Clinical Exome and Pediatric Neurology Region of Interest diagnostic tests in New York.
After a five-year pilot, only one company has successfully taken a test through parallel review, but there is growing industry interest.
The test can now be used to screen for sickle cell trait, a condition in which an individual carries one of the two abnormal genes responsible for sickle cell disease.
The state has given its approval for the company to market its ThyGenX next-generation sequencing oncogene panel for indeterminate thyroid nodules.
NPR says the explosion and fire earlier this week at a Russian lab that stores dangerous pathogens revives the question of whether such samples should be kept.
According to Wired, Nebula Genomics is providing a way for people to get their genomes sequenced anonymously.
A 26-year-old woman tells Cosmopolitan about learning her APOE status at a young age.
In Science journals this week: a functional genomic screen uncovers drug combination that increases KRAS inhibitor efficacy in aggressive lung cancer, and more.