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 FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.
The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.
The German drugmaker plans to advance the NSCLC treatment in parallel with tissue-based and liquid biopsy companion assays that can identify best responders.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.
