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Roche Gets FDA Clearance for Hepatitis B PCR Test

NEW YORK (GenomeWeb News) – Roche has received US Food and Drug Administration clearance for its Cobas TaqMan HBV Test, the firm said today.
 
The test uses real-time PCR to quantify the amount of hepatitis B virus DNA in a patient’s blood. It may be used by physicians to determine a baseline level of infection and thereafter as an aid in assessing a patient’s response to therapy.
 
According to Roche, it is the first hepatitis B viral load test approved for marketing by the FDA.
 
Roche’s real-time HIV test was cleared by the FDA in May 2007, and the firm has filed for clearance of its quantitative HCV test.

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.