Close Menu

FDA

The company also inked a deal with an investment bank to publicly offer from time to time up to $4.2 million of its stock.

The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.

The US Food and Drug Administration has issued an emergency use authorization for a test for the 2019-nCoV coronavirus.

The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.

If granted, emergency use authorization is anticipated to help roll out standardized, consistent 2019-nCoV testing to public health labs in the US. 

The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.

The diagnostic firm has agreed with Streck to incorporate its blood collection tubes into sample collection protocols for its genomic lung cancer tests.

The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.

Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.

Having raised $1.5 million in funding since announcing the project at a 2017 AACR meeting, the group anticipates completing the first phase of the project by Q2 2020.  

Pages

The Atlantic reports another SARS-CoV-2 testing problem may be lurking: backlogs.

Researchers have sequenced the genome of "the Methuselah of freshwater fish."

The US Biomedical Advanced Research and Development Authority is supporting efforts to develop vaccines against SARS-CoV-2.

In Genome Biology this week: difference in methylation in neurons from Parkinson's disease patients, differential expression analysis by barcoded sequencing approach, and more.