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KRAS Biomarkers

News and reporting on KRAS biomarkers.

"With genomics, and pharmacogenomics, and all the other aspects of the cancers, we have to think of a different way than the randomized trial," said Patrick Loehrer, interim director of Indiana University's cancer center and a member of FDA's Oncology Drugs Advisory Committee.

The protocol for the trial, which will study overall survival in Vectibix-treated chemorefractory patients with wild-type KRAS tumors, is currently being reviewed by the FDA.

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paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance.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.

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NPR reports that researchers have developed chimeric embryos as part of work toward growing human organs in animals for organ transplants.

According to the Washington Post, the Biden Administration is set to make changes to federal restrictions on fetal tissue research.

Texas Monthly looks into the DNA Zoo being collected by Baylor College of Medicine researchers.

In Science this week: approach to isolated trace DNA from archaic humans from sediments, and more.