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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

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.