Clinical OMICS

MAY-JUN 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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Page 16 of 50 May/June 2019 Clinical OMICs 15 to "over fit" the data. Second, biostatistical methods require a user, with the potential for bias, to manage or impose cutoffs in the data. "We felt that a new method of analytics, or predictions sys- tems, was needed." To identify the clinically informative signature, the test interro- gates the expression signature of microRNA (miRNA) and small nucleolar RNAs (snoRNAs) isolated from urinary exosomes. The signatures were identified using NRS Classification Algorithm on a training data set of 235 patients with known pathology and clinical outcomes. This established the performance characteristics of the classification platform. The signa- tures were identified using NGS and are currently identi- fied in samples using standard high-throughput molecular screening techniques. miR Scientific plans to have the test available within a year. Currently, the company is preparing to apply for CLIA lab certification, which will allow it to perform tests at their own facility. Simultaneously, the company is performing a clinical trial in preparation for filing for FDA approval of a kit that can be sold to third-party commercial clinical testing labs. The company is also preparing to launch a urine liquid biopsy platform for blad- der cancer management and has platforms for liver and kidney cancer in the works. —Camille Mojica Rey, Ph.D. n Foundation Medicine, like PGDx, is still focusing their efforts on using liq- uid biopsy for treatment selection and has not made public any plans to move into EDT development. "The immediate impact for liquid biopsy today is one of looking for ther- apy selection and, in some regards, that also refers to looking at the develop- ment of resistance," said Prasanth Reddy, M.D., Foundation Medicine's VP of med- ical affairs. Reddy also said that an important application for liquid biopsy is monitoring tumor burden to determine therapeutic efficacy. In 2018, the company announced the launch of Founda- tionOne Liquid. The test, which requires two 8.5 ml samples of blood, provides genetic information and microsatellite instability (MSI) status for use in treatment selection. It ana- lyzes 70 genes known to drive cancer growth, including homologous recombination deficiency genes, and reports the genomic biomarker for microsatellite instability to help inform the use of checkpoint inhibitor immunotherapies and multiple targeted therapies, including poly (ADP-ribose) polymerase (PARP) inhibitors. The test allows physicians to gain insights into the molecular drivers of cancer in an indi- vidual patient. "We can use that information to determine whether a potential treatment may be suitable for a specific patient at a specific time in their cancer journey," Reddy said. As for EDTs, Reddy said: "There are some things that need to be worked out on the clinical end, (including) how to inte- grate very sensitive ways of detecting potential tumors in a patient." For example, physicians will need to know what to do if a patient tests positive using an EDT, he said. In general, keeping oncologists informed about the lat- est technology is a common challenge in the field of liquid biopsy, according to Guardant's Talasaz. "One of the bot- tlenecks of precision oncology is physician education about new technology in the field, how much we know about the genomics and the molecular properties of tumors, and the novel therapeutics that are commercially available. There are some gaps there. It's a field that is moving very fast." Guardant's strategy has been to build collaboration with key opinion leaders and generate lots of clinical publication on liquid biopsy. More than 110 studies have been published that used the Guardant360 test and collaborators have used it in 40 clinical utility studies to-date. "The that thing really helped us is that the unmet need is so huge. Physicians were hoping for this to work." tap10 / E+ / Getty Images Prasanth Reddy, VP , Foundation Medicine

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