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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Oct 13, 2011


Beijing-based China Medical Technologies said this week that China's State Food and Drug Administration has approved its real-time PCR-based KRAS assay as a companion diagnostic test for the use of a targeted colorectal cancer drug.

KRAS mutations occur in 30 percent to 60 percent of colorectal cancers and are associated with poor response to EGFR inhibitors such as Amgen's Vectibix and Merck's Erbitux.

China Medical did not disclose the name of the drug for which its assay was approved as a companion diagnostic.

Citing figures from the Chinese Ministry of Health, the company said that around 170,000 new colorectal cancer cases are diagnosed each year in China.

The UK's National Policing Improvement Agency has agreed to evaluate Epistem's Genedrive point-of-care molecular testing device as part of the NPIA's Accelerated DNA Profiling Technology Program, Epistem said this week.

The NPIA will use Genedrive to target single tandem repeats used for human forensic identification.

If the trial is successful, "the NPIA could use Genedrive to enable rapid and accurate DNA analysis at a crime scene," Epistem said.