Clinical OMICS

MAR-APR 2017

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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www.clinicalomics.com March/April 2017 Clinical OMICs 29 is also a breast cancer specialist at Dana Farber . "It is close to 40%, if not more, of tumors that have ESR1 mutations, which presumably accounts for a substantial fraction of the resistance to antiestrogen therapies." For metastatic breast cancer, he added, current practice to discover this information relies on complete biopsy of the metastatic site, which provides a number of hurdles, includ- ing the fact that a tissue biopsy only captures the cancer at a moment in time, from a single site, and will likely not find all actionable mutations due to tumor heterogeneity . Fur- thermore, the tissue biopsies are technically demanding and invasive, such that many patients are reluctant to undergo the procedure . "Liquid biopsy really opens the possibility of a kind of real-time molecular analysis of the tumor to help inform treatment choices," Dr. Burstein concluded. The Burden of Proof Despite the success of employing liquid biopsy to inform clinical decision making for NSCLC, researchers, and liquid biopsy technology companies say it is still early days, and that both clinicians, and public and private payers will need compelling evidence of the technology's mettle . "I think the medical world everywhere is very conser- vative, and change is not particularly easy for them," said Andrew Newland, CEO of CTC separation technology com- pany ANGLE . "What we are doing at ANGLE is putting a lot of emphasis into clinical studies . It is too easy to think the standard of care will change unless we can provide extremely good evidence that has been accredited by insti- tutions of very high caliber." Guardant Health is taking a similar tack in its approach to the market . To address this challenge, the company has recently struck partnerships with leading cancer centers such as MD Anderson and the Lurie Cancer Center of Northwestern University, to compile clinical utility data . "There is a lot of excitement—and rightly so—with liq- uid biopsy. But, unfortunately, there is a difference between technology and actually changing the standard of care, and getting it reimbursed," said Dr. Eltoukhy. "There is this talk of liquid biopsy being a $20 billion to even a $100 billion opportunity . But none of that is realizable unless liquid biopsies become a reimbursed—with reimbursed being the operative word—standard of care . "It is not just at progression, or therapy selection, it is also multiplying that by all the different cancer types where you can do that—breast cancer, lung cancer, colon cancer, etc . —and then further multiplying that by looking at that in the adjuvant setting, first line, residual disease, monitoring, near adjuvant, and recurrent detection." In the short term, changes in how payers will reimburse for cancer panels and sequencing may lead diagnostic provides to only focus on those mutations that meet that burden of proof . Where companies providing these service were once reimbursed via code stacking for the related pro- cedure, and may have sequenced for a broad range of tumor mutations, now they are only getting reimbursed for spe- cific actionable mutations. "Payers have worked toward having the codes changed away from a procedural base, toward an actual particular diagnostic," said Brunel. "The MACs, more than the private payers, have recognized that there may be a use for broader panels in a triage setting, where you don't really have many options left and you want to look at that tumor more broadly to see if there might be a mutation that would be targetable in a clinical study . There is going to be payment for panels, but it is not great, so there is more of an argument that needs to be made." Despite the need to untangle payment issues, Brunel thinks liquid biopsy is now poised to make a significant leap in adoption across all care settings, not just in academic medical centers . "Right now, I think most clinicians would tell you liquid biopsy is ready for prime time," he concluded. "Given turn- around time and access to material—i . e . , the ability to draw blood and get a result—it is likely to become as prevalent as tissue." Both circulating tumor cells and circulating tumor DNA provide significant insight to each person's disease and cancer progression. ttsz / Getty Images

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