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 12 of 50 May/June 2019 Clinical OMICs 11 pany's president and COO. "Our philosophy from the start was to begin with advanced cancer patients, understand the circulating tumor DNA, understand the biology better over time, and, in a systematic way, go to earlier stage testing." Of all the potential clinical applications of tumor-derived cfDNA, early detection is one of the most ambitious. The tests rely on the fact that mutations in tumor-derived cfDNA are highly specific markers for particular cancer types. This specificity is key in order to minimize false-positives. Large case-controlled studies are required to establish sensitivity and specificity to ensure accurate identification of patients with early-stage disease. The effort presents unique com- putational challenges, requiring multi-disciplinary teams working together. Researchers are rapidly developing new computational methods that increase the accuracy of NGS. Creating pan-cancer EDTs, ones that test for the most com- mon cancer types, also means of improving on currently liq- uid biopsy tests by being able to accurately determine the location of a tumor within the body. Improving sensitivity In December 2018, Guardant launched its LUNAR assay for use in biopharmaceutical and academic research for the detection of early-stage cancer and recurrence of disease in patients with lung, colorectal, ovarian, and breast cancer. (A clinical version of the test for investigational use only in prospective studies is expected to launch in the second half of 2019.) The technology is based on data from testing 80,000 advanced cancer patients using Guardant360. It includes all genes recommended for profiling by the National Compre- hensive Cancer Network, including the 73 genes most rele- vant to clinical care. The test can detect tumor DNA in the blood with 90-95 percent accuracy. In addition to Guardant360-generated data, the com- pany also based LUNAR on whole-genome sequencing liquid biopsy data and information from publicly-avail- able databases, such as the TCGA and PubMed. The new test uses epigenetic data to increase sensitivity. "We real- ized that if we just looked at genomic data in blood, we were going to have limited sensitivity detecting tumor signatures at an early stage," Talasaz explained. LUNAR includes assessment of methylation and DNA fragmenta- tion patterns—ones that vary between normal cells and cancerous ones. Research findings using LUNAR, which provides results in seven days, are showing promise, Talasaz said. Findings from a colorectal cancer study that included 105 recently diagnosed cancer patients and 125 cancer-free, age-matched healthy patients were presented at the American Association for Cancer Research annual meeting in March 2019. "With just using a single blood test in patients that have been recently diagnosed, we can (continued on next page) KATERYNA KON / SCIENCE PHOTO LIBRARY / Getty Images

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