The development of multiplex companion diagnostics is driven by the need to understand efficacy and safety at both the molecular and phenotypic levels. In the future, personalized therapeutic regimens will be tailored to each patient’s genomic, transcriptomic, and epigenomic profiles to optimize individual outcomes.
For personalized (or precision) medicine to become a sustaining reality, all stakeholders—patients, healthcare professionals, drug development companies, regulatory agencies and payers—must work together.
Advancing multiplex companion diagnostics technology was among the topics discussed at CHI’s “Next Generation Diagnostics Summit,” an event held recently in Washington, DC.
“Pharmaceutical companies are more comfortable today with the value of using a personalized medicine approach in their drug discovery and development programs,” explained Jeremy Bridge-Cook, Ph.D., senior vp of research and development at Luminex.
“Reimbursement changes and inconsistencies constrained the market in 2013 and will need to be sorted out, or personalized medicine and its ability to deliver substantial healthcare savings will be slowed down dramatically.”
Rather than being the exception, companion diagnostics are becoming the norm in oncology. In other clinical areas, such as chronic and infectious diseases, advancements in biomarker programs are also being made. Many of these programs are at an earlier stage, however, with some just entering clinical trials.
Multiplex assays mitigate patient risk. For example, approximately a quarter of the drugs used clinically today are metabolized by cytochrome P450 2D6. The Luminex xTAG® CYP2D6 Kit v3 can be used as a clinical aid in determining therapeutic strategy. The qualitative genotyping assay analyzes 20 different cytochrome P450 2D6 variants and identifies metabolic differences, which can be used to help evaluate the risk of adverse events.
Another challenging syndrome is Alzheimer’s disease. Most of the damage caused by Alzheimer’s disease happens subclinically, before clinical symptoms emerge. Already a big problem, Alzheimer’s disease will become a larger problem as baby boomers age and become more susceptible.
The use of a biomarker test for earlier diagnosis is thought by many to be a better way to demonstrate efficacy of a drug for halting Alzheimer’s progression. Luminex and Merck recently announced a partnership around a companion diagnostic for an Alzheimer’s disease compound in development.
Reimbursement remains an issue. Increasingly, evidence based on healthcare economic trials will be required to prove that a precision medicine approach reduces healthcare system costs.
Clinical trials demonstrate clinical outcomes. Healthcare economic trials are essentially the same activity, except that outcomes are measured in economic, not clinical, factors. Standard cost of care is compared to the cost of a personalized approach, that is, a model in which a companion diagnostic is followed by a precision therapeutic.
“Healthcare economic trials have been implemented for some time—just not for companion diagnostics. The industry as a whole is still learning, and although there is a pilot program in its infancy between the FDA and CMS, there is no set protocol,” concluded Dr. Bridge-Cook.