Skip to main content

FDA Clears Cepheid's GBS Test as IVD, Lifting Shares 8 Percent

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Cepheid's Xpert clinical molecular diagnostic for Group B Streptococcus, the company said today.
 
The test runs on the GeneXpert Dx system and is an in vitro diagnostic designed to detect Group B Strep DNA in vaginal and rectal swabs. It is the first test “in a planned menu of Xpert tests” based on the GeneXpert platform, said Cepheid CEO John Bishop.
 
The 510(k) clearance paves the way for Cepheid to market the test in the United States.
 
Shares in Cepheid rose 8 percent, or $.67, to $8.87 in mid-afternoon trading on the news.

The Scan

Pfizer-BioNTech Seek Full Vaccine Approval

According to the New York Times, Pfizer and BioNTech are seeking full US Food and Drug Administration approval for their SARS-CoV-2 vaccine.

Viral Integration Study Critiqued

Science writes that a paper reporting that SARS-CoV-2 can occasionally integrate into the host genome is drawing criticism.

Giraffe Species Debate

The Scientist reports that a new analysis aiming to end the discussion of how many giraffe species there are has only continued it.

Science Papers Examine Factors Shaping SARS-CoV-2 Spread, Give Insight Into Bacterial Evolution

In Science this week: genomic analysis points to role of human behavior in SARS-CoV-2 spread, and more.