The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument.
The firm said that it is on track to seek FDA approval for a liquid cytology solution early this year.
The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month.
The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.
Researchers identified a form of Bacillus cereus from wild and domestic animals in West and Central Africa that contains virulence plasmids found in B. anthracis.
The Taiwanese research team that developed the method showed in a new study that it could better detect BRAF mutations than conventional PCR plus Sanger sequencing.
The firm sees the new panel as an important step forward in its strategy to further penetrate the molecular diagnostics market with its qPCR products.
Last month, the companies announced that Takara Bio USA — formerly Clontech Laboratories and now a subsidiary of Japan's Takara Bio — would acquire WaferGen.
Researchers also found that higher frequencies of BRAF V600E mutations in the blood were associated with poorer outcomes and less responsiveness to BRAF inhibitors.
The test was developed by Quest's Focus Diagnostics subsidiary and is the first from a commercial lab to receive an EUA.
In Science this week: genetic target for urothelial bladder cancer treatment, and more.
At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.
Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.
Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.