FDA

The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said. 

The ResistancePlus MG Positive Control kit was listed with the FDA for sale in the US, where it will be sold through SpeeDx's US entity.

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

The agency finalized recommendations for developing and validating NGS tests, and proposed a submission process for investigational IVDs in cancer Rx trials.

Ease Up

Some cancer researchers are pushing to relax clinical trial eligibility requirements, according to Nature.

Bit of Concern

The Washington Post notes that some health professional are wary of complex direct-to-consumer genetic testing.

The New York Times writes that right-to-try bills might not lead to better drug access.

Increasing NIH funding has been a priority for Congress in recent years, despite calls from the White House to trim the agency's budget.

CEO Patrick Soon-Shiong said that GPS Cancer test revenues rose threefold year over year during Q4, and 606 GPS tests were ordered, up from 325 a year ago.

At the ACLA conference this week, FDA Commissioner Gottlieb outlined his vision for the agency in the realm of LDTs.

Pages

In an against-all-odds twist, a researcher studying exceeding rare FOXG1 mutations discovers her daughter has the syndrome.

An effort by Genomics Medicine Ireland is creating a database of diseases based on the genomics of people in Ireland. It now is looking into the possibility of including Scotland in its work.

In recent weeks, the direct-to-consumer genetics firm has rolled out a health hub where customers can share information concerning 18 common health conditions.

In PLOS this week, new genes associated with prostate cancer risk, genetic patterns in M. bovis, and more.