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Liquid Biopsy & Cancer Commons Presentations Highlight Afternoon of Day 2 of Precision Medicine World Conference (PMWC) 2018

In the afternoon sessions of Day 2 of the Precision Medicine World Conference (PMWC) 2018, the Track 2 Liquid Biopsy Showcase continued with a series of talks. The first was given by George Karlin-Neumann, PhD, Director of Scientific Affairs, Digital Biology Center, Bio-Rad Laborartories. At Bio-Rad, Dr. Karlin-Neumann is helping to drive the research and clinical adoption of droplet digital PCR through collaborations and internal research programs, especially in cancer liquid biopsy. He noted that the benefits of droplet digital PCR include absolute quantitation, high precision and sensitivity, high throughput, and removal of PCR efficiency bias. A second talk was delivered by Andre Marziali, PhD, President & CEO, Boreal Genomics; and Professor, University of British Columbia. Dr. Marziali and the R&D team at Boreal hold 19 issued patents on methods for high-accuracy next-generation sequencing library preparation technologies to reduce the cost of liquid biopsy assays. Dr. Marziali highlighted Boreal’s OnTarget Circulating Tumor DNA (ctDNA) Analysis technology. The customer can select pre-configured or custom panels of up to 100 mutations; submit plasma, FFPE and fresh-frozen tissue, or DNA samples; and receive a report with mutations quantified at ≥0.01% abundance. The OnTarget™ services are for research-use only, not for diagnostic use. The next presentation was delivered by Atul Sharan, President & CEO of CellMax Life. Sharan is a trained engineer who was previously President & CEO at AutoESL, and Founder, President, & CEO at Clear Shape Technologies. Sharan founded CellMax Life after his wife had been cleared of breast cancer in a mammogram and then, just weeks later, was diagnosed with breast cancer via additional testing. His wife is fine today, but this experience coupled with his increasing knowledge of cancer, convinced Sharan of the paramount importance of early diagnosis in cancer. Early detection can lead to earlier treatment and much increased chances of treatment success. CellMax seeks to provide globally affordable early cancer detection blood tests. CellMax Life has developed a proprietary platform-microfluidic chip, antibody, and imaging software- that Sharan believes has enabled CellMax to be the only company to overcome the “intractable” challenge of detecting rare CTCs in pre-cancer and early-stage patients, when cancer can be most successfully treated. Once CTCs are captured via the CellMax platform, the company can analyze the CTCs comprehensively for multiple clinically relevant biomarkers—DNA, and also RNA, protein expression, and methylation. The CellMax platform can also be used in in the capture and analysis of circulating tumor DNA (ctDNA) to enable early detection of cancer. Sharan referred to a January 16, 2018 ASCO press release (https://www.asco.org/about-asco/press-center/news-releases/liquid-biopsy...) that reported results of a Taiwan study using a CellMax assay to detect CTCs in screening for colon cancer. The testing yielded specificity values of 97.3%, indicating a very low (less than 3%) probability of a false-positive result. The study results further showed that sensitivity ranged from 77% for detection of CTCs in pre-cancerous lesions, to 87% for stage I-IV cancers. The researchers also calculated the accuracy of the results, which takes into account both sensitivity and specificity, and found that the accuracy of the test was high and ranged from 84% to 88% between pre-cancerous and cancerous samples. The accuracy of this test was superior to that of fecal occult blood testing (FOBT). In commenting on the affordability of the test, article co-author Ashish Nimgaonkar, MD, gastroenterologist and Medical Director in the Center for Bioengineering Innovation and Design at Johns Hopkins University, Baltimore, Maryland said “A number of studies have found that affordability was the number one reason for not being screened, however this test is highly affordable and can potentially cost less than $100.” Dr. Nimgaonkar also noted that colonoscopy would still be the gold-standard diagnostic test and would be needed for tumor or polyp sample removal if an individual had a positive CTC test. The authors of the Taiwan study are currently planning to validate the use of CTC testing in the general population in Taiwan and to conduct studies in the U.S. According to the authors, the technology used in this study potentially could be used with other solid tumors, such as breast, lung, and prostate cancer.

PHIL FEBBO, GENOMIC HEALTH

Next to the podium was Phil Febbo, MD, CMO, Genomic Health. Dr. Febbo has held leadership positions at UCSF, as well as Genomic Health. At UCSF, Dr. Febbo was Co-Leader of the Prostate Cancer Program at the UCSF Helen Diller Family Comprehensive Cancer Center and the Program Principal Investigator of the Translational Research Program for the Alliance for Clinical Trials in Oncology. The mission of Genomic Health is to transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics and services. The company believes it is the world’s leading provider of genomics-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer. The company’s Oncotype DX portfolio of breast, colon, and prostate cancer tests applies advanced genomic science to reveal the unique biology of a patient’s tumor in order to optimize cancer treatment decisions. By providing answers to key questions about the aggressiveness of, and appropriate treatment for, early-stage cancer, these practice-changing tests help physicians and patients select the right treatment at the right time in each individual case. In this way, Oncotype DX testing helps patients and their physicians to optimize their cancer care and outcomes, enabling many patients to avoid unnecessary procedures and therapies, and saving the healthcare system billions of dollars in unnecessary costs. With over 850,000 patients tested in more than 90 countries, Genomic Health’s Oncotype DX tests have helped define a standard of care in precision medicine by making genomics a critical part of cancer diagnosis and treatment.

Genomic Health’s new Oncotype SEQ Liquid Select is a liquid biopsy mutation panel that uses next-generation sequencing to identify and assess actionable genomic alterations of a select 17 genes to help personalize treatment of patients with stage IV solid tumor cancer, including lung, breast, colon, melanoma, ovarian or gastrointestinal stromal tumor (GIST). As a clinically actionable blood-based panel, Oncotype SEQ is designed to help meet the needs of oncologists by delivering insights into targeted therapy options for the more than 350,000 cancer patients who recur or present with late-stage disease each year in the United States.

The test was developed to detect specific genomic alterations to help doctors and patients evaluate treatment options based on select genomic cancer markers that have either been included in National Comprehensive Cancer Network (NCCN®) guidelines, associated with sensitivity or resistance to relevant FDA approved therapies, or established as eligibility criteria for currently enrolling Phase II-IV clinical trials.
Based on successful completion of the company’s analytical validation study, Oncotype SEQ is now commercially available under CLIA. The results of the analytical validation study are being submitted for presentation at a major medical meeting. Additionally, the company has begun a clinical concordance study to establish further evidence to support reimbursement. The company believes that its unique experience of delivering molecular tests into clinical practice through its world-class commercial channel - including strong relationships with community physicians, combined with the company’s expertise in demonstrating clinical utility and gaining reimbursement for value-based tests - positions Genomic Health to make a significant impact in this emerging field of liquid biopsy.

RICHARD WILLIAMS, GRAIL

The following speaker was Richard Williams, PhD, Group Medical Director, GRAIL. Dr. Williams serves as project leader for GRAIL’s Circulating Cell-Free Genome Atlas (CCGA) Study, which will characterize the landscape of cell-free nucleic acid profiles in several thousand individuals with cancer and in thousands of healthy, non-cancer participants using GRAIL’s “high-intensity” (ultra-broad and ultra-deep) sequencing approach. GRAIL believes that reliable detection of cancer at an early stage, before symptoms appear, has the potential to dramatically decrease global cancer mortality. Dr. Williams noted that GRAIL plans to launch a cell-free DNA-based assay later this year in Hong Kong for the early diagnosis of nasopharyngeal carcinoma (NPC). NPC is much more common in Asia (35/100,000) than in the US (4/100,000).

MARTY TENENBAUM, CANCER COMMONS

In the late afternoon in Track 1 (Artificial Intelligence in Precision Medicine), Marty Tenenbaum (photo), PhD, Founder & Chairman, Cancer Commons, gave a presentation titled “How AI Will Cure Cancer.” Dr. Tenenbaum is a renowned computer scientist, Internet entrepreneur, and cancer survivor. He is the Founder and Chairman of Cancer Commons, a non-profit network of physicians, scientists, and patients that Newsweek has called the “LinkedIn of Cancer.” He currently also serves as a Director of CommerceNet and Efficient Finance. Cancer Commons (https://www.cancercommons.org/) is a patient-centric not-for-profit network of patients, physicians, and scientists that helps identify the best options for treating an individual’s cancer. Members contribute to, and benefit from, a uniquely dynamic knowledge base of case histories, treatment insights and rationales, clinical trials, and patient outcomes and experiences. Each case builds on this collective knowledge, enabling more accurate personalized options for the next community member.

By learning from each and every patient in this way, Dr. Tenenbaum believes we can optimize and expand the use of available treatments far more efficiently than by clinical trials, and rapidly improve outcomes for patients with advanced cancer. Cancer Commons fosters a network of leading physicians, molecular tumor boards, cancer researchers, and computer scientists to leverage one another’s expertise and resources, and empower the global community to share data and knowledge. The Commons provides relevant knowledge from top experts and from similar patients so that patients and their caretakers can make better, more informed treatment decisions. Cancer Commons continuously validates and refines the world’s collective cancer knowledge, based on patients’ clinical results and the latest research.

Dr. Tenenbaum believes that Cancer Commons is unique because, in the era of molecular medicine, advanced cancers are characterized by thousands of genetic alterations, potentially creating tens of thousands of clinically distinct subtypes. Moreover, there are hundreds of approved therapies, which have never been tested head to head, or in combinations. Conventional clinical trials cannot efficiently search this huge combinatorial space.

In the absence of definitive clinical studies, the best way to help current patients is by aggregating and validating the insights, intuitions, and experiences of our best clinicians. By capturing the unique experiences of patients being treated at top centers with investigational drugs and cocktails, Cancer Commons will enable the whole cancer community to learn, much more efficiently than by traditional clinical trials, the best way to treat similar patients wherever they are seen. Given the wide variation in cancer treatment and outcomes across institutions, Cancer Commons is convinced that its efforts to learn from the best and get that knowledge to the right patients and physicians at the right time will save innumerable lives, even without new blockbuster drugs.

Dr. Tenenbaum believes that only a patient-centric non-profit like Cancer Commons, committed to connecting and leveraging everyone touched by cancer, can hope to overcome the widespread aversion to data sharing and collaboration that pervades the medical establishment.

(Photo credit: Rosalyn Lee, PMWC).

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