The growth of personalized medicine,which aims to better target treatments to patients through the use ofinformation about an individual’s genes, proteins and environment to prevent,diagnose and treat disease, is expected to increase the number of alliancesbetween diagnostic and pharmaceutical companies, according to a newPricewaterhouseCoopers LLP (PwC) report entitled Diagnostics 2009: Movingtowards personalized medicine. “We expect alliances with the pharmaceutical industry to increase in thenext two-to-five years, but this will be driven by factors including thepricing of diagnostics, the extent of reimbursement coverage, and the burdenof any clinical validation work required for market access,” said GeraldMcDougall, principal, health sciences practice, PricewaterhouseCoopers.The report highlights the prominence of personalized medicine in currentmerger and acquisition (M&A) and licensing deal activity in the in vitrodiagnostics (IVD) sector. In 2008, personalized medicine motivated three ofthe 10 largest M&A deals and four of the licensing deals by the 10 largest IVDcompanies. According to the report, a number of factors are expected to drive thecontinued development of personalized medicine and why diagnostics will becomemore important, including: — Regulatory agencies, including the U.S. Food and Drug Administration(FDA) and European Medicines Agency (EMEA), which are supporting thefield of personalized medicine by introducing formal requirements totest for certain biomarkers prior to prescribing certain drugs. — Legislation introduced in May 2008 in the United States and Europe toprotect individuals against discrimination resulting from the use ofgenetic information may now encourage more people to undergo genetictesting or participate in innovative research. — Genentech’s Citizen Petition of December 2008, which created newmomentum around the discussion of the diversity of regulatory paths tomarket for in vitro diagnostics. — The formal adoption of new diagnostic technologies in the guidelinesof important clinical communities, which should accelerate theirmarket adoption. Agendia’s MammaPrint (a DNA-based test for evaluatingan individual’s risk of breast cancer spreading to other sites) is anexample of a new diagnostic tool to help personalize treatment, whichwas recently validated by a national clinical group in the Netherlands- the Dutch Institute for Healthcare Improvement. Although the effort to better personalize treatments is not new,significant further progress is needed because current patient response ratesto medicines can be very low – varying from 20 percent to 75 percent dependingon the drug. Pressure from healthcare payers is putting more emphasis on theavailability of a companion biomarker test when deciding on a drug’sreimbursement, says PricewaterhouseCoopers. Companion diagnostics arediagnostic tests designed to guide the prescribing of a specific drug byassessing a patient’s risk of adverse events or likelihood of therapeuticeffectiveness when taking this drug. “Increasingly, pharmaceutical companies will not move a drug candidate tothe clinical development stage without a clear biomarker development program,”added McDougall. “These companies understand the contribution of biomarkersand diagnostics in improving the design and probability of success of clinicaltrials. These factors will combine to accelerate the development of newdiagnostics for personalized medicine. Together we anticipate that alliancesand collaboration will be inevitable as the market need expands.”
