Skip to main content
Premium Trial:

Request an Annual Quote

FDA Says CLIA Labs Can Use Cepheid's Xpert GBS Test in POC Setting

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has said CLIA labs can use Cepheid’s Xpert Group B Streptococcus test, Cepheid said today.
 
Last month the agency cleared the test as an in vitro diagnostic. The recent move, which categorizes the Xpert test as "moderate complexity," means the test can be used by 27,000 additional labs.
 
Cepheid said the Xpert assay is the first amplified molecular diagnostic using real-time PCR to receive the moderate complexity CLIA categorization.
 
The test is designed to detect Group B Strep DNA in vaginal and rectal swabs in the point-of-care setting.
The Scan

US Booster Eligibility Decision

The US CDC director recommends that people at high risk of developing COVID-19 due to their jobs also be eligible for COVID-19 boosters, in addition to those 65 years old and older or with underlying medical conditions.

Arizona Bill Before Judge

The Arizona Daily Star reports that a judge weighing whether a new Arizona law restricting abortion due to genetic conditions is a ban or a restriction.

Additional Genes

Wales is rolling out new genetic testing service for cancer patients, according to BBC News.

Science Papers Examine State of Human Genomic Research, Single-Cell Protein Quantification

In Science this week: a number of editorials and policy reports discuss advances in human genomic research, and more.