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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

WHO OKs Emergency Use of Sinopharm Vaccine

The World Health Organization has granted emergency approval for Sinopharm's SARS-CoV-2 vaccine, the Guardian reports.

Scientific Integrity Panel to Meet

According to the Associated Press, a new US scientific integrity panel is to meet later this week.

Trying in the Eye

NPR reports that a study of Editas Medicine's CRISPR therapy for Leber congenital amaurosis has begun.

PLOS Papers on Cerebellum Epigenetics, Copy Number Signature Tool, Acute Lung Injury Networks

In PLOS this week: epigenetics analysis of brain tissue, bioinformatics tool to find copy number signatures in cancer, and more.