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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.

The Scan

J&J Booster Support

A US Food and Drug Administration advisory panel has voted to support a booster dose of Johnson & Johnson's SARS-CoV-2 vaccine, according to the Los Angeles Times.

To Keep the Cases Moving

The president of the UK Royal College of Pathologists tells the Financial Times that more investment is needed to tackle a backlog of cases.

NAS Expels Archaeologist

Science reports Luis Jaime Castillo Butters' expulsion is the first of an international member from the US National Academy of Sciences.

PLOS Papers on Angelman Syndrome-Like Cases, Salmonella Paratyphi A, SARS-CoV-2 in Brazil

In PLOS this week: exome sequencing analysis of Angelman syndrome-like cases, genetic epidemiology of Salmonella Paratyphi A, and more.