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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40 Clinical OMICs July/August 2019 15 in the journal Biological Psychiatry, the company identi- fied some of these subtypes, which are associated with dys- regulation of amino acids and branched-chain amino acids. The study offered the first results from the NIH-funded Children's Autism Metabolome Project (CAMP), the larg- est clinical study of the metabolism of children with ASD. CAMP is a large-scale effort to define autism biomark- ers based on metabolomic analyses of blood samples from 1,100 children ages 18 to 48 months. NeuroPointDX reasons that its metabolomics approach to detecting ASD risk holds substantial prom- ise for identifying objective biomarkers because metab- olism is sensitive to interac- tions among the genome, gastrointestinal microbiome, diet, and environmental factors—all of which contribute to an individual's unique metabolic signature. NeuroPointDX was set to present its case for test reim- bursement in late June with officials from the Centers for Medicare & Medicaid Services (CMS). Difficult road to travel "The venture capital community says, 'Well, when you have positive EBIDTA, come see me.'" Donley laments. "That's a difficult road to travel, and it is definitely having an impact on innovation and human health." In the absence of investor money, the $8 million CAMP study was funded by a grant from the National Institutes of Mental Health, the Nancy Lurie Marks Family Foundation, and the Robert E. and Donna Landreth Family Fund. Diagnostics developers don't generate as much for their tests as biopharmas do for their drugs and vaccines— accounting for their greater leverage in negotiating partner- ships to develop companion diagnostics, observed Aurélie Deleforge, precision medicine practice lead with Bionest Partners, a global consulting firm focused on pharma, bio- tech, medical device and diagnostic development. Deleforge expects that leverage to balance out better for precision diagnostics companies over time. "The more precision medicine we progress and advance, the more the balance should change, because pharma com- panies will depend so much on diagnostics—if you don't get this test in, you won't get the drug," Deleforge said. Reimbursement challenges are even more pronounced in Europe, where decisions are made country-by-country. Deleforge cited the wide disparity in reimbursement rates for next-generation sequencing tests, which range from about €400 (approximately $450) in the U.K. to about €3,000 (about $3,400) in Germany. Diagnostic and drug developers, she added, have a shared interest in seeing wider reimbursement for personalized tests: "They need to reimburse the diagnostic test, otherwise nobody will perform the test, and hence the drug will just never be prescribed." Another catalyst for changing the relationship, Deleforge added, is the emerging involvement of companies focused on managing and analyzing healthcare data, especially as they interact with drug and diagnostics developers. Roche, for example, made two key acquisitions last year signaling an expanded presence in precision medicine and oncology. The pharma giant shelled out $2.4 billion to expand its majority stake in Foundation Medicine into full ownership of the cancer-focused molecular diagnos- tics developer. Roche also spent $1.9 billion to buy Flat- iron Health, a healthcare technology and services company whose offerings are designed to support cancer-care provid- ers and life sciences companies. At the starting point "We're in a really fascinating period right now, with such an exponential increase in data that is digitized and therefore can be analyzed, which I think didn't exist at this scale even (left to right) Jennifer Cozzone, global personalized healthcare lead, specialty care, Roche; Aurélie Deleforge, precision medicine practice lead, Bionest Partners; Elizabeth Donley, CEO of Stemina Biomarker Discovery and its NeuroPointDX business unit; and moderator, Erin McCallister, senior editor, BioCentury discussed the challenges of precision medicine adoption outside of cancer care at BIO 2019 in Philadelphia. Aurélie Deleforge, precision medicine practice lead with Bionest Partners

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