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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14 Clinical OMICs May/June 2019 www.clinicalomics.com ian cancer to 33 percent for breast cancer. Unlike available liquid biopsy tests, CancerSEEK accurately determines the location of the tumor. Researchers estimated that the future commercially available test would cost about $500. "This test represents the next step in changing the focus of cancer research from late-stage disease to early disease," said Bert Vogelstein, a professor of oncology and one of the authors of the Science paper, in a press release. Fast-moving field Not all liquid biopsy companies are trying to move into the EDT space, but are instead developing new applications for liquid biopsy in patients with cancer at various stages. "We still see that there is a lot of work for us to do in the advanced cancer space," said John Simmons, Ph.D., vice president of translational medicine at Personal Genome Diagnostics (PGDx). For example, the company has early development programs focused on detecting minimal residual disease and monitoring. "Physicians want to know information about what kinds of resistant mechanisms have emerged and whether those are targetable by approved drugs or eli- gible for clinical trials," Simmons said. In March, the company announced that it received Euro- pean safety certification, the CE mark, for its PGDx elio plasma resolve. The test is the first kitted plasma-based NGS oncology test to have that certification. The qual- itative test uses NGS to detect single nucleotide variants, small insertion/deletions, amplifications, rearrangements, and microsatellite instability in a broad multi-gene panel in circulating cfDNA isolated from blood samples. It includes several clinically actionable variants across tumor types, enabling more informed treatment decisions. "The majority of patients with advanced stage cancer are not receiving any NGS testing," Simmons said. In fact, he added, many cancer patients are not having the complete compendium of molec- ular tests performed that could direct their therapy. All-in-One Prostate Cancer Platform miR Scientific is preparing to launch an all-in-one, non-invasive prostate cancer management platform based on urine liquid bi- opsy technology that can identify clinically significant prostate cancer in three days. The platform, called the miR Scientific PCa Sentinel Score, uses tumor exosome-derived small non-cod- ing RNA (sncRNA) expression signatures. The platform includes screening, classification, and monitoring tests, and is designed to be a stand-alone system. "Most tests in the marketplace are ad- junctive. We are producing the information without having to re- fer to any other prior test or any other prior information," said Sam Salman, CEO of miR Scientific. In recent years, there has been some debate over the PSA screening blood test for prostate cancer, the only minimally inva- sive test currently available. A significant problem with that test is subsequent testing to determine the cause of an elevated PSA test can be invasive, stressful, expensive, and time-consuming. That's because the PSA alone cannot identify clinically significant cancer. Another limitation of the present system is that tests used in diagnostics, screening, and prognosis are not integrated. In- stead, they are performed and analyzed by different segments of the healthcare system. "There is a lot of variability and subjectiv- ity," Salman said. Because of this, men with prostate cancer—the second most lethal cancer in men—often undergo unnecessary tissue biopsies. "These are a series of problems a disease manage- ment system that is integrated can solve." The three integrated components of the miR platform take advantage of the unique RNA signatures present on the surface of tumor exosomes, which have been shown to be involved in cancer progression and metastasis. In March 2019, miR Scientif- ic presented a validation for the classification component of the platform at the European Association of Urology annual meeting in Barcelona, Spain. Prostate cancer tumors are classified by grade group (GG), with GG2 and above designated as clinically signifi- cant. The study showed that the platform correctly identified 87 out of 88 patients with GG1 tumors and 55 of 56 patients with clinically significant cancer (GG2-5). According to Salman, the Sentinel platform is unique in that it utilizes an unbiased biomarker, addressing two shortcomings in computational oncology. First, machine-learning algorithms tend (continued from page 12) Unlike available liquid biopsy tests, CancerSEEK accurately determines the location of a tumor.

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