Clinical OMICS

JUL-AUG 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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44 Clinical OMICs July/August 2019 www.clinicalomics.com we have a best-in-class test—sensitiv- ity, specificity and also turnaround time. We think we are leading the market in all of those. Also, the field is evolving so rap- idly it's not a case of build a test and commercialize one test. It is more of a pipeline story of how do you develop technologies and, indeed, branch into other technologies to provide these solutions to patients. Different tech- nologies will work better in different settings and that is what we want to do—to determine where they can solve areas of unmet needs. Our current technology is appropriate in some settings, but not all. We will bring additional technologies from other areas. What we want to do is build, over time, a portfolio of liquid biopsy products that address multiple area of unmet need. What is your turnaround time? Morris: We offer seven days from the time of taking the blood sample. The reason that is important is it fits in with the weekly clinical cycle—clinicians tend to work on a weekly basis. They want to see the patient today, draw the blood, and bring the patient back into the clinic next week to start whatever treatment is appropriate. Do you see your technology being used as an early cancer screening tool? Morris: Our strategy is, at the moment, to focus on those patients who have already been diagnosed with cancer, not to do the early detection or screening. Our view is, with the technology we have, let's maximize the value of what this can do for patients right now: residual dis- ease, disease monitoring, recurrence, disease stratifica- tion, and advanced disease monitoring. There is a big unmet need around lung cancer and getting patients to therapy. A study published in 2017 on community oncology in the U.S. showed less than 10% of patients were profiled for all of the FDA-ap- proved drugs, never mind the investigational drugs. That's just criminal. People are dying of lung cancer who just aren't getting these therapies. A big part of that is the difficulties with tissue in lung cancer and we can overcome that. ctDNA technologies are here to stay, they are not just hype and hope and then some- thing that disappears. They are actually cementing in clinical practice. Once you do that, then you branch out and find additional uses. How can you get people to adopt your tests? Morris: The first part is having good data, doing the right clinical work, and having the right clinical trials. We have clinical validation data published that shows the performance of the test. There are also two transi- tions that need to be made: transition people from reli- ance on just tissue to considering blood. Then, having made that first leap, providing education on which is the best blood test to do. Is there opportunity for Inivata to engage with pharma for co-development and the creation of companion diagnostics? Morris: That is absolutely the intent. If you think about what you need for a companion diagnostic, you need something that is ideally freely available and that is one of the advantages of a broad platform. You are not doing a single-gene test. It is not a test for a single cancer drug, but potentially many on one panel. But you want great performance. You want high sensitivity and high speci- ficity to be able to get the most patients. Now that InVisionFirst-Lung will be reimbursed by Medicare, how will you get private payers on board? Morris: One of the reasons we have reimbursement cov- (continued from previous page) One of the reasons we have reimbursement coverage from Medicare is we put together the full clinical program and demonstrated the value of that test in practice." travenian / iStock / Getty Images

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