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FDA Approves Roche KRAS Mutation Test for Metastatic Colorectal Cancer Patients

NEW YORK (GenomeWeb) — The US Food and Drug Administration has approved Roche's real-time PCR cobas KRAS Mutation Test for diagnostic use, the company said today.

The test helps to identify metastatic colorectal cancer patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective because their tumors carry no KRAS mutations.

The cobas KRAS mutation test, which is a TaqMelt assay that runs on the cobas 4800 system, detects mutations in codons 12 and 13 of the KRAS gene and can be performed in less than eight hours.

It adds to two other oncology tests that Roche offers on the cobas 4800 in the US, the cobas BRAF V600 Mutation Test for melanoma and the cobas EGFR Mutation Test for lung cancer.

The Scan

New Study Investigates Genomics of Fanconi Anemia Repair Pathway in Cancer

A Rockefeller University team reports in Nature that FA repair deficiency leads to structural variants that can contribute to genomic instability.

Study Reveals Potential Sex-Specific Role for Noncoding RNA in Depression

A long, noncoding RNA called FEDORA appears to be a sex-specific regulator of major depressive disorder, affecting more women, researchers report in Science Advances.

New mRNA Vaccines Offer Hope for Fighting Malaria

A George Washington University-led team has developed mRNA vaccines for malaria that appear to provide protection in mice, as they report in NPJ Vaccines.

Unique Germline Variants Found Among Black Prostate Cancer Patients

Through an exome sequencing study appearing in JCO Precision Oncology, researchers have found unique pathogenic or likely pathogenic variants within a cohort of Black prostate cancer patients.