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