The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.
The nonpartisan federal agency's report suggests ways for Congress, the FDA, FTC, and CMS to expand oversight of the genetic testing market.
Diaceutics is projecting that FDA will soon approve more personalized drugs than all-comer drugs, but absent changes in diagnostics strategies many patients won't receive them.
The company's revenues were driven by its centralized and point-of-care solutions as well as its molecular diagnostics business, both rising in the single digits.
The company launched a "core" service using Illumina microarray genotyping, and has plans for an expanded NGS offering with Quest Diagnostics.
Canadian regulators are beginning to share information from new drug studies, Undark reports.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
Hallmarks of the genetic disease, which can result in life-threatening cardiac complications, include progressive weakness and loss of heart muscle.
The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
The organizations noted in a letter to HHS and FDA that they "believe the agency's actions may in fact inflict greater harm on patients and impede innovation."
According to Gizmodo, researchers have developed a list of a million nucleic acid-like polymers that could store genetic information.
An opinion piece in the Washington Post argues that golden rice could save the sight and lives of many children.
US National Institutes of Health has issued a new draft data-sharing policy, ScienceInsider reports.
In Cell this week: analysis of immune microenvironment in hepatocellular carcinoma, proteogenomic analysis of clear cell renal cell carcinoma, and more.