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.
"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paper on drug/diagnostic co-development, genomic advances have marched on, requiring the agency to revisit its now outdated guidance.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.
"If approved by the FDA, the DxS TheraScreen: K-RAS Mutation Kit would become a companion diagnostic for use with Erbitux in metastatic colorectal cancer to determine which patients have wild-type KRAS status in the US," DxS said this week.