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EDITOR'S PAGE

In recent months, a flurry of IVD industry announcements related to personalized medicine have been issued, primarily to publicize the creation of collaborations between IVD companies and big pharma. Such collaborations could significantly affect the future direction of the development of diagnostic tests that clinicians would use to predict the likely outcomes of drug therapies, and could bring personalized medicine closer to realizing its full potential sooner than expected.

In one such arrangement, Celera (Rockville, MD) and Merck & Compnay Inc. (Whitehouse Station, NJ), have entered into a research collaboration to develop biomarker and pharmacogenomic tests for cancer patients (see Trends & Perspectives, page 18). Under the terms of this agreement, Celera will evaluate certain gene expression profiles identified by Merck with the goal of developing diagnostic predictors for Merck’s clinical trials. Such diagnostic predictors could form the basis for commercial companion IVD tests for oncology therapies.

GE Healthcare (Chalfont St. Giles, UK) followed up with its own announce­ment of a three-year collaborative research agreement with Eli Lilly and Co. (Indianapolis) to discover and develop advanced IVD assays that may predict patient response to targeted cancer therapies. The goal of this collaboration is to discover key protein and gene signatures that will predict the likelihood of a medication’s effectiveness in treating certain cancers.

In addition, Ventana Medical Systems Inc. and the Critical Path Institute (both in Tucson, AZ) received a $2.1 million grant from Science Foundation Arizona for a collaboration project with FDA and the National Cancer Institute. The goal of this project is to establish performance standards and evaluation processes that would serve as the model for future cosubmissions to FDA of companion diagnostic tests and their associated targeted drug therapies.

All of these agreements are encouraging signs that the IVD and pharmaceutical industries, along with regulatory bodies and research organizations, are more and more recognizing the potential benefits of personalized medicine. Furthermore, diagnostics and drug companies are realizing the need for them to work together in order to make personalized medicine come to fruition.

According to John Sninsky, PhD, vice president of discovery research at Celera, “One of the things that people appreciate now more is the discrete nature of the information that is available in pharmaceutical companies relative to diagnostics companies. In the context of companion diagnostics, it’s important to bring these knowledge bases together to go forward, because each one of them by itself doesn’t have sufficient information to develop a clear and comprehensive strategy for targeted medicine.”

One of the major projected growth areas in the IVD industry is the development of companion diagnostic tests for personalized medicine. In order for such growth to be realized, IVD manufacturers should heed Sninsky’s advice and actively establish collaborations with pharmaceutical companies.

Richard Park