Close Menu

FDA

The in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses and can characterize viruses as seasonal or nonseasonal.

The firm's clinical service revenues were up also 51 percent, and it also announced it has signed a contract with insurer Humana.

The Life Sciences business grew 10 percent year over year, while the Diagnostics business inched up 1 percent.

Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.

How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.

Qiagen's test is intended to identify advanced bladder cancer patients with alterations in FGFR3 or FGFR2 genes and who are likely to respond to erdafitinib.

For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.

Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.

The firm is seeking approval of myChoice HRD as a test that can identify ovarian, fallopian, or peritoneal cancer patients deficient in homologous recombination DNA repair.

The New York Times reports on Scott Gottlieb's plans as he steps down as commissioner of the US Food and Drug Administration.

Pages

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.