Clinical OMICS

JUL-AUG 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com July/August 2019 Clinical OMICs 39 Looking Beyond Cancer Precision medicine poised for growth outside oncology, but reimbursement, acceptance remain hurdles By Alex Philippidis P recision medicine is ready to advance beyond oncol- ogy, but the personalized paradigm must yet surmount several hurdles if it is to gain wide usage by physicians, providers, and especially patients, a panel of industry executives agreed. Highest of those hurdles is reimbursement by payers for new targeted tests. Panelists also cited other challenges for adoption of precision medicine into indications outside of cancer, including winning acceptance of new diagnos- tic technologies by physicians and payers, identifying the right biomarkers, and persuading investors to back per- sonalized assays. "As a company that seeks funding from the financial community, I can tell you that venture capitalists are not interested in funding diagnostics," said Elizabeth L.R. Donley, CEO of Stemina Biomarker Discovery and its NeuroPointDX business unit. She spoke during "Precision Medicine Beyond Oncology," a panel discussion during the recent Biotechnology Innovation Organization (BIO) 2019 International Convention, held in Philadelphia. The difficulty test developers have in winning reimburse- ment doesn't square away, Donley acknowledged, with the desire for positive earnings before interest, taxes, depre- ciation, and amortization (EBIDTA) by investors. "They become mezzanine financers where it comes to diagnostics, and it's because the industry standard is that you'll be paid for 60% of your tests, an average of 180 days, and possibly as long as 720 days after you deliver the product." NeuroPointDX aims to address the unmet need for earlier diagnosis and more precise treatment of autism spectrum disorder (ASD) by developing a panel of biomarkers that detects a large proportion of people at risk for ASD, with which Donley's son has been diagnosed. The U.S. Centers for Disease Control and Prevention (CDC) last year esti- mated 1 in 59 children had been identified with ASD, though more recently cited estimates have increased that slightly to 1 in 58. Using proprietary ana- lytical methods, Neuro- PointDX has created tests intended to identify unique subtypes of metabolism in children with ASD. In a study published February Elizabeth Donley, CEO, NueroPointDx Stanislaw Pytel / DigitalVision / Getty Images

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