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KRAS Biomarkers

News and reporting on KRAS biomarkers.

Genomic Health discussed the status of its ongoing work with Pfizer in renal cancer and suggested it might eventually develop a companion test for Erbitux that gauges mutations "beyond KRAS."

"The drugs that are being associated with our diagnostic tests have market potential in existing sales in the multi-billions of dollars," Schatz said this week at an investor conference in New York.

Abbott gets FDA nod for RealTime HBV assay; Asuragen launches KRAS and BRAF mutational testing services.

In an out-of-court settlement, Qiagen and Roche decided they both would have distribution rights to TheraScreen tests from Qiagen subsidiary DxS.

After missing the first-to-market opportunities with KRAS, both Merck KGaA and Amgen are strategically looking into additional gene markers, with the likely aim of being able to launch companion tests to their drugs that are more sensitive and accurate than the competition.

For Dx shops developing pharmacogenomic tests without big pharma's help, Medco says it can offer a better value proposition when it comes to driving adoption and reimbursement for their tests.

"Our data reinforce the importance of the KRAS mutation as a predictive biomarker for responsiveness to Vectibix therapy," said Roger Perlmutter, Amgen's executive vice president of research and development.

Since the FDA's 2005 preliminary concept paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance. A new white paper from the Personalized Medicine Coalition points out the areas requiring additional regulatory and evidentiary clarity from the agency.

At a meeting hosted by the Partners HealthCare Center for Personalized Genetic Medicine last month, the events leading up to the re-labeling for colorectal cancer drugs Vectibix and Erbitux sparked discussion among participants about what Amgen and Bristol-Myers Squibb/ImClone knew about the drugs and when.

In acquiring DxS, Qiagen is attempting to increase its presence in molecular diagnostic-based personalized healthcare. Meantime, coming under the Qiagen umbrella is likely to provide a relatively small personalized medicine firm like DxS a global reach and more negotiating clout with large pharma and biotechs.

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Researchers have developed a robotic lab assistant, the Verge reports.

CBC News reports Canada's Supreme Court is to rule on the constitutionality of the country's genetic non-discrimination law today.

The Associated Press reports the World Health Organization is sending experts to China to investigate the animal source of SARS-CoV-2.

In Science this week: atlas of affected cell populations in idiopathic pulmonary fibrosis, and more.