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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42 Clinical OMICs January/February 2018 www.clinicalomics.com Expanding Access to Liquid Biopsy Testing While industry continually invests in liquid biopsy testing, 2017 was the first year cancer networks and private payors began recogniz- ing the value these tests offer as an alternative to traditional solid tumor biopsies. In May, the National Comprehensive Cancer Network (NCCN) expanded its guidelines to include liq- uid biopsy tests. Consequently, national payer networks amended their current policies to include coverage for some to them. This should come as no surprise since NCCN guidelines serve as the gold standard for influencing prac- tice patterns and inform coverage policies in the U.S. For cancer patients unable to undergo a solid tumor biopsy, these changes in coverage determinations provide access to an alternative testing method that can help guide treatment decisions and monitor for disease recurrence and treatment resistance. However, the new proposed coverage as outlined by the Centers for Medicare & Medicaid Services (CMS), albeit a huge step forward for NGS-based testing in coverage determinations, excludes any mention of liquid biopsy testing. If left unchanged, this directly impacts the cancer patients that stand to benefit the most from advances in liquid biopsy tests for personalized medicine. CMS' coverage decisions can also often dictate what the rest of the industry does. While this coverage decision offers opportunities for solid tumor NGS-based testing, it could impose significant implications for other genetic–based tests, such as those using liquid biopsies if passed in its current state. CRISPR Gene Editing This is an easy highlight in many respects — there's been absolutely no doubt about the extraordinary potential of CRISPR/Cas9 gene editing as a transcendent tool in basic and medi- cal research since the seminal Doudna/Charpen- tier report published in 2012. "Can CRISPR Cut it in the Clinic?" was the question Clinical OMICs posed in its July/August cover story. Even as that story was going to press, advances were coming out with dizzying speed. Shoukrat Mitalipov (Oregon Health Sciences University) led the first American group to successfully correct a dis- ease gene in human embryos. George Church's company eGenesis reported a major advance in engineering the pig genome in a breakthrough for xenotransplantation. And HHMI/Harvard/ Broad chemist David Liu's team published beautiful work using a modified Cas9 not as a nuclease but as a marker for ultra-precise "base editing," while his Broad colleague Feng Zhang, working with Jim Collins, developed a method dubbed SHERLOCK for RNA diagnostics. And let's not forget that an older form of gene edit- ing, using zinc fingers, arrived in the clinic in the form of a Sangamo-funded trial for Batten dis- ease. We can barely imagine where the science of gene editing will take us in 2018. KEVIN DAVIES Executive Editor The CRISPR Journal JOYDEEP GOSWAMI President Clinical NGS and Oncology, Thermo Fisher Scientific out or effectively manage cancer. The anti-PD1 drug (pembrolizumap/Keytruda), a drug that stimulates the immune system to attack cancer- ous cells, was demonstrated in patients across a broad range of cancers to substantially reduce their tumors, and in 20% of patients the tumor was eliminated and had not returned. Based on these results, the FDA approved pembrolizu- map for all patient with MSI-H, regardless of the tumor type (the first such approval ever). Like- wise, the genetic alteration of T cells to create chi- meric antigen receptor T (CAR-T) cells, can tune them to signatures of tumor cells that are specific to the tumor (as opposed to normal cells in your body) and terminate such cells. This year, this technique was combined with one of the biggest advances in genomics over the last several years, a genome–editing approach known as CRISPR/ Cas9. With this powerful genome editing tool, CAR-T cells can be engineered to be even more potent, with this genome-editing approach evolving to produce these cells within a patient's body rather than in the lab, using DNA-carrying nanoparticles (in mice, at least, this approach resulted in leukemia regression). (continued from previous page)

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