Molecular diagnostics, one of the fastest growing segments in the diagnostics market, are key enablers in delivering personalized medicine. According to industry consultants, molecular diagnostics are set to become the dominant platform in clinical medicine. But currently only about 10% of labels for FDA-approved drugs contain pharmacogenomic information.
One of the challenges, experts say, is the current regulatory environment; diagnostics are evaluated by the FDA as devices. But this could change shortly. Last year, the FDA made a commitment to developing new scientific standards to establish…
Growth Areas in Molecular Diagnostics
Cynthia Gawron-Burke, Ph.D. Director, Scientific Liaison External Scientific Affairs, Oncology Licensing, Merck
Research Laboratories, which develops medicines, vaccines, and biologic therapies. For more information, visit merck.com/mrl.
Hans Johansson. VP, Phadia AB and Head of Phadia Development Business, which develops, manufactures, and markets systems for immune response diagnostics. For more information, visit phadia.com.
Walter Koch, Ph.D. VP, Head of Global Research, Roche Molecular Diagnostics, which offers a broad range of diagnostic and blood screening assays. For more information, visit molecular.roche.com.
Stephen Little, Ph.D. VP of Personalized Healthcare, Qiagen, which provides companion diagnostics for personalized healthcare. For more information, visit qiagen.com.
Michael Nohaile, Ph.D. Head of Molecular Diagnostics, Novartis Molecular Diagnostics, a unit within Novartis Pharmaceuticals that leverages the company’s capabilities to translate identified biomarkers into innovative diagnostic tests to improve patient outcomes. For more information, visit moleculardiagnostics.com.
Cecilia Schott, Pharm.D. Business Development Director, Personalized Healthcare and Biomarkers Group, AstraZeneca, which is a global, biopharmaceutical business with a focus on the discovery, development, and commercialization of prescription medicines. For more information, visit astrazeneca-us.com.