A recently announced deal between GE Healthcare-subsidiary Clarient and Glaxo Smith Kline will create a force in cancer testing, according to Kalorama Information. The healthcare market research publisher tracks companion products, and says that the two entities will form a multi-purpose, data analytics- and companion diagnostics-driven network of laboratories. Kalorama Information recently released a market study, Companion Diagnostics Market, for companion diagnostics such as the drug-test combinations envisioned in this deal.
“The trend in cancer testing is that companies, even large entities, can't do it alone,” said Bruce Carlson, Publisher of Kalorama Information. “This is one example of a partnership between a test manufacturer and a maker of biopharmaceuticals.”
While operational details of the newly reached agreement have yet to be provided, certain parameters of the program already outlined in the announcement highlight the unique benefits that diagnostic specialists and pharmaceutical companies can expect in partnerships:
- GE Healthcare, Clarient and GSK will certify laboratories around the world to perform cancer diagnostic tests with initial network labs expected in 2015. Clarient's own laboratory expertise includes immunohistochemistry (IHC), flow cytometery, qPCR, (fluorescent) in-situ hybridization ([F]ISH), cytogenetic karyotyping, microarrays, and next-generation sequencing (NGS).
- Lab testing networked by GE Healthcare and Clarient will focus initially on 70 melanoma-specific mutations, including the companion diagnostics (CDx)-targeted BRAF V600E and V600K genes.
- Testing performed at networked labs will feed an associated data analytics service to be made available by GE Healthcare as a subscription. GSK will presumably be provided the same service to aid its activities in biopharmaceutical development.
- The GE-Clarient-developed lab and data analytics service will be available to clients including pharmaceutical market participants, payers and other healthcare organizations. Patient testing data can be used dynamically to improve patient care and personalized treatments, perform geospatial analysis, epidemiological analysis, and to recruit patients to oncology-related clinical trials.
Kalorama says that in this move, GSK is competing with Swiss pharmaceutical-diagnostics conglomerate and leader in CDx Roche, which has already released a Zelboraf-BRAF V600 mutation treatment pairing and released data from Phase III of its trial of cobimetinib for BRAF V600 mutation-positive melanoma patients. GSK has developed products through IVD partners before. GSK and bioMérieux developed the THxID BRAF CDx qPCR test kit – approved by the FDA in May 2013 – to identify melanoma patients with the BRAF V600E or V600K gene mutation and thus candidates for treatment with the oncology drugs Tafinlar and Mekinist.