Clinical OMICS

JAN-FEB 2018

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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6 Clinical OMICs January/February 2018 News UCSF Clinic Bridges Traditional versus DTC Genomic Divide University of California, San Francisco's UCSF Health aims to bridge the divide between traditional genetics and direct- to-consumer (DTC) testing through its new Preventive Genomics Clinic. "The main goal of the clinic is to offer an option for people who have questions and wouldn't traditionally need to see a doctor about them, but who could get, in my opinion, better clinical support than trying to do it themselves online," Bryce Mendelsohn, M.D., Ph.D., a UCSF clini- cal geneticist and the clinic's lead clini- cian, told Clinical OMICs. He and genetic counselor Marta Sabbadini, Ph.D., see two to three patients a week, with capacity to see a few hundred people a year, with plans to expand staffing based on demand. "We're trying to cautiously get the word out that we're available just to provide that navigation, but we're not selling tests," Mendelsohn said. Instead, the clinic consults with healthy adult patients without a family background of genetic disease. Patients seeking a diagnosis for active symp- toms, or for conditions for which they have a strong family history, are referred to UCSF specialty clinics focused on can- cer, heart disease, neurodegenerative disease, or other genetic conditions. Consultations cover patient goals and values, as well as the benefits and lim- itations of testing. Sometimes, Mendel- sohn said, patients contacting the clinic about getting tested change their minds: "That's totally fine with me." Located in San Francisco, the Clinic offers carrier screening, cancer and heart disease risk screening, pharmacogenetic testing, and broad genome screening combining those tests. Sequencing and analysis are carried out offsite at CLIA labs, and Mendelsohn and Sabbadini discuss testing results with patients. Patients are billed for a specialty med- ical visit, plus testing. Aside from carrier screening, often covered by insurance, most tests require out-of-pocket costs that can run several hundred dollars, with whole exome and whole genome tests stretching into the thousands. Mendelsohn said patients include young people interested in starting fam- ilies, people seeking information about potential side effects to medications recommended by their doctors, peo- ple simply curious about what genetic conditions may run in their families— including those with questions after ordering DTC tests, which account for at least half the Clinic's patients. "Direct-to-consumer testing has been a real boon for the field. It's gotten peo- ple engaged and interested in a way that wouldn't have happened if it were just us doctors doing it," Mendelsohn said. "As the quality of evidence gets bet- ter, and when clinical grade tests become more affordable, I think that genetics can move back into the mainstream of medical practice, and be something that healthy people can do with their doc- tor, and not have to do it themselves." — Alex Philippidis The Preventive Genomics Clinic uses off-site CLIA labs for testing and analysis. mately 120 samples previously tested in a 299-patient study whose results were presented at the American Tho- racic Society (ATS) 2017 International Conference, held May 19–24 in Wash- ington, DC. The CLIA validation was aimed at demonstrating that Onco- Cyte's new clinical laboratory could provide the same results on clini- cal samples as those obtained in its R&D lab. "The clinical validation study has now begun and is expected to be com- pleted in the fourth quarter of 2017," OncoCyte stated following comple- tion of the CLIA validation study. The day after the delay was dis- closed, OncoCyte announced the appointment a new CFO, Mitch Levine, a finance veteran with expe- rience in fundraising for early stage companies. Levine previously served as managing partner of Kirby Cove Capital Advisors, a provider of con- sulting services to international life sciences investment funds focused on collaboration and investment in U.S.– based life sciences companies. "The delay had no impact on the timing of the CFO appointment," Annett said. "The company had been engaged in a CFO search for a number of months and are very pleased that its top candidate, Mitch Levine, has joined OncoCyte." (continued from page 3) STEVE GSCHMEISSNER / Getty Images

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