Why do over 99% of published biomarkers never reach the clinic? Biomarker discovery and implementation experts Kenneth Emancipator, MD, and Surendra Dasari, PhD, will explain common pitfalls and maximize opportunities for success through illustrative examples in today’s late-breaking session, “Precision Medicine: from Novel Biomarkers to Blockbuster Drugs.”
Millions of participants around the world have been enrolled in precision medicine initiatives that are collecting massive amounts of data. These studies are aimed at identifying metrics that better classify patients into defined groups that will benefit from specific treatments. Bridging the gap between putative biomarker data points into clinically useful biomarkers is essential for fulfilling the promise of precision medicine.
In 2017, the FDA made an unprecedented approval for the immunotherapy pembrolizumab for all unresectable or metastatic solid tumor cancers on the sole basis of biomarkers: tumors with either microsatellite instability or mismatch repair deficiency, regardless of tumor type. Emancipator, who is executive medical director and head of companion diagnostics for Merck & Company, he led the team that developed the PD-L1 protein expression test that is a companion diagnostic for pembrolizumab.
Although Emancipator will focus on PD-L1 as a key biomarker for pembrolizumab treatment in non-small cell lung cancer, he will stress that he expects the community “to see a steady increase in the number of companion diagnostic tests for the foreseeable future.” During the session, he will emphasize that every laboratorian should feel “an imperative to prepare his or her own laboratory for the age of precision medicine.”
Oncology has been a foundational area of biomarker development, but researchers are actively exploring many other areas of acute and chronic conditions. Dasari, an assistant professor of biomedical informatics at the Mayo Clinic, will explore the reasons why he believes that biomarker discovery is an overused term. He plans to focus his talk on anchoring biomarker discovery to unmet clinical needs—crucial to translating biomarkers from research to the clinic. Dasari’s own research has shown promise using non-invasive proteomic biomarkers for accurately subtyping amyloidosis subtypes and tissue-based diagnosis of fibrillary glomerulonephritis.
A challenge for implementing biomarkers in medicine that is recognized by both Dasari and Emancipator is physician education. “As new tests and techniques come to the market, physicians…will need to be educated about the pros and cons of new tests and [the] proper interpretation and application of the test results,” Dasari said.
According to Emancipator, this is a “familiar challenge for the laboratory community,” but it’s one that “represents an opportunity for laboratorians to serve as educators and consultants for the physicians they support.”
Despite the hurdles that must be overcome before a biomarker becomes standard-of-care, the lessons these experts will present are a primer for laboratory professionals. Clinical trials are currently investigating a wealth of biomarkers in many diseases and, Dasari believes that “precision medicine starts with laboratory testing and it cannot exist without laboratory testing.” Similarly, Emancipator expects that companion diagnostics will be among the highest impact tests performed in the clinical laboratory