Innovative tests for patient-tailored treatments: demonstrating value in the age of personalized medicine.

The days of the blockbuster business model of drug development are winding down. Budget pressures, coupled with the rapidly increasing knowledge of personalized medicine, will soon cease to sustain pharmaceutical companies that expect to live by sales of prescriptions for patients who will not respond, who will respond suboptimally or who will respond adversely to drugs. The realization of personalized medicine presents an unprecedented transformative opportunity - it is clearly the future of the pharmaceutical industry and of healthcare. Like many chronicles in healthcare, however, the development of the innovative tests required for personalized medicine has so far proved to be one of twists and turns, challenges and hope. One needs only to look to the developing research associated with CYP2C19 genetic testing, a marker that indicates a poor response to the antiplatelet therapy clopidogrel for some 30% of patients that carry the specific alleles. Several commercial laboratories in the USA immediately began offering a laboratory-developed CYP2C19 assay, but treating physicians were left with questions as to what treatment alternatives should be used if a patient is identified as a poor metabolizer of clopidogrel. Is the carrier information itself meaningful without knowing what action to take? Manufacturers of innovative diagnostics need to engage clinicians and other stakeholders with value propositions that are clearly communicated and supported through evidence and funding real-world population studies through manufacturer-payor partnerships.