Skip to main content
Premium Trial:

Request an Annual Quote

Roche Launches Melanoma Companion Dx in EU After FDA OK Last Week

Premium

Roche said this week that European regulators have cleared its Cobas BRAF mutation companion diagnostic for the melanoma drug Zelboraf (vemurafenib).

The European launch comes just a week after the US Food and Drug Administration approved both the assay and drug, which is still under review in the EU.

Roche co-developed Zelboraf with Daiichi Sankyo to treat melanoma patients whose tumors express the BRAF V600E mutation, which is found in about half of all malignant tumors, and which the Cobas BRAF test can detect.

The Cobas BRAF test is a real-time PCR-based assay that runs on Roche's Cobas 4800 system, a consolidated and flexible in vitro diagnostic platform coupled with software that automates result interpretation, analysis, and reporting, the company said.

Roche said in a statement that it clinically validated the test in two studies to identify tumors carrying the BRAF V600E mutation.

It also said the assay has several advantages compared to the commonly used method of Sanger sequencing, such as "greater sensitivity and reliability for detecting mutations and quicker results, allowing doctors to know whether a person with inoperable or metastatic melanoma is eligible for treatment with Zelboraf."

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 is 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.