Of Biomarkers and CDxes

GEN| October 27, 2017

With emphasis in oncology shifting significantly to immune therapies, the days of companion diagnostics testing for one marker to prescribe one drug are rapidly changing. Pharmaceutical companies are dipping into the past to examine forgotten biomarkers and are looking to new analytical platforms and methods to provide definitive information on new drugs. Clinical OMICs recently asked five different questions to five leaders in biomarker and companion diagnostic development for their views on this quickly evolving area.

Clinical OMICs: Most companion diagnostics are for oncology, what needs to happen for the development of CDx in your field of central nervous system disorders?

Andreas Jeromin, Ph.D., Scientific and Medical Advisor for Quanterix: One of the challenges in CNS disorders for companion diagnostics is understanding the biology. Alzheimer’s disease is not a single disease, it is a continuum of a disease that is based on a clinical diagnosis that is not necessarily reflected in disease mechanism.

For Alzheimer’s disease, the holy grail in CNS has been the detection of biomarkers in cerebral spinal fluid. Over the last two or three years we have continuously engaged in studies where we described and quantified some of these proteins not just to have diagnostic utility, but to really understand what Alzheimer’s disease is. We are going from understanding the biology, understanding the mechanisms, validation of assays, into an LDT type strategy, all the way to companion diagnostics. But we need a lot of clinical data. Just running a 3,000-patient clinical trial, which seems like a lot of patients, doesn’t generate the clinical data needed to develop a companion diagnostic.

Large datasets will come into the public domain, this is what is going to change. The way we are running clinical trials is not just based on these clinical outcome measures, but subjective measures. Everyone is interested in wearables now, as well. So there are multiple elements where we will see a lot of demographic normative data being utilized in the design of clinical trials, hopefully resulting in shorter approval and clearance of a companion diagnostics.

Read the rest of the article at genengnews.com