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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Nov 11, 2010


Gen-Probe has launched in Europe the Elucigene KRAS.BRAF kit, a single-tube assay for the simultaneous detection of seven common KRAS mutations and the V600E BRAF mutation.

The CE-marked assay provides valuable information regarding mutation status that can help clinicians determine the most appropriate treatment course for patients with metastatic colon cancer, Gen-Probe said.

Elucigene KRAS.BRAF is a single-tube, amplification refractory mutation system-PCR-based fluorescent assay that is performed on Life Technologies' Applied Biosystems genetic analyzers. The assay is validated for use on DNA extracted from formalin-fixed paraffin-embedded tissue samples; requires minimal hands-on time; and comes with pre-mixed reagents, thus requiring only the addition of patient DNA. Gen-Probe said that the test has achieved a 1 percent detection sensitivity of mutant sequence in a normal background.

China Medical Technologies said this week that it has received approval from the State Food and Drug Administration of China for its real-time PCR-based epidermal growth factor receptor assay for the use of lung cancer-targeted drugs.

The EGFR PCR assay is used to detect the 28 most common somatic mutations in the EGFR gene in patients with non-small cell lung cancer, and provides a quantitative assessment of mutation status to determine the use of lung cancer-targeted drugs, CMT said.

The assay is CMT's first PCR-based EGFR assay for lung cancer drugs; and is also the first to be approved by the SFDA, the company said.