Molecular diagnostics uses molecular signatures for disease identification, monitoring treatment effectiveness and even predicting a patient’s response to a new treatment. Although adoption of this technology in the clinical laboratory setting has been slower than anticipated, novel tools continue to create vastly superior alternatives to the established methods. Molecular diagnostics has gained more significance as medicine shifts toward targeted or personalized treatment methods.
Select Biosciences’ “Molecular Diagnostics World Congress”, which was held in Philadelphia recently, provided opportunities for companies in the field to exchange information and design new strategies.
“The tipping point in the field of molecular diagnostics will occur once pharmaceutical companies fully realize the value of integrating drug development with companion diagnostics,” said Eddie Blair, M.D., Ph.D., managing director, Integrated Medicines (www.integratedmedicines.co.uk). “Companion diagnostics could not only expedite the development of drugs but could also decrease the attrition rate. Stratification of the population based on predictive biomarkers could increase efficacy and safety of drugs developed for target populations. Physicians could thus make more informed decisions. Companion diagnostics could also increase the commercial value of drugs, and possibly extend the life of some patents.”
A well-known case of such co-development is Herceptin (trastuzumab) and the HER-2 test. Overexpression of the HER-2 receptor is linked to decreased patient survival. Herceptin was approved in 1998 to treat metastatic breast cancer in patients who overexpress HER-2 protein. Its FDA approval was dependent on the concomitant approval of a diagnostic immunohistochemistry (IHC) assay (now known as Dako HercepTest®).
Another example of a companion program is LpPLA2 (lipoprotein-associated phospholipase A2) immunoassay, developed by diaDexus(www.diadexus.com) and approved for predicting the risk of heart disease and ischemic stroke. GlaxoSmithKline(www.gsk.com) is developing a small molecule designed to inhibit this enzyme, thus reducing the risk of adverse cardiovascular events.
“Our calculations demonstrate that the net present value of a drug with a companion test nearly tripled in comparison with a stand-alone drug,” continued Dr. Blair, “but the established mentality does not change overnight. However, additional pressure from the regulatory agencies is aiding the paradigm shift.”
In 2005, the FDA issued guidance encouraging drug and biologic developers to conduct pharmacogenomic tests during drug development. FDA’s Critical Path Initiative further emphasizes development of predictive diagnostics.
“The immediate goals of Integrated Medicines include facilitating more widespread use of approved diagnostic tests in the promotion and marketing of medicines,” concluded Dr. Blair. “We also promote exclusive co-development of diagnostic tests with new medicines. We may be a little ahead of the curve in this respect.”