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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www.clinicalomics.com July/August 2019 Clinical OMICs 43 is considered the gold standard on a single gene test— but with the benefits of testing a broad panel. What does the company see as the advantages of this technology? Morris: If you think about PCR, or digital droplet PCR, it is very, very sensitive and very, very specific. There is a reason nature has been using PCR effectively to repli- cate DNA since the beginning of time, so we take exactly that and then we apply that to circulating tumor DNA. The challenge with PCR is how do you scale it? Doing individual PCR reactions isn't tenable across many genes. How do you look at these complex changes in gene translocation, gene fusions, and things that wouldn't naturally be done by PCR? We found a way to do that, to multiplex across many hundreds of dif- ferent areas. We also cover things like single nucleo- tide variants, insertions, deletions, and copy number gene translocations. We've adapted the technology— called Tam-Seq—to be able to do that and that is our InVision platform. Earlier this year the InVisionFirst-Lung liquid biopsy test received a local coverage decision from Palmetto GBA, assuring reimbursement from Medicare in the U.S. What about efforts in the rest of the world? Morris: Like many companies, we will start in the U.S. and try to be successful here. At our lab in Cambridge [U.K.], we can service across the European Union and beyond. The way we have built our workflows are for them to be modular. We can do two things with that: One, as our volumes go up in our current labs, we can add modules, and that just scales out. Two, we can also transplant different modules into different labs, so it should be relatively straightforward for us to set up new labs in different geographies as we need to. We will look to partner overseas and certainly in Asia. In Europe we will probably do a little bit of both—some commercialization our- selves, but also look for local partners as well. Where do you see the sweet spot in the market for Inivata and how do you compete with the larger, more established players? Morris: There is a range of different places we can apply this technology, never mind additional technologies we may access and develop. The first one is this lung can- cer patient stratification tool and getting that all the way through to reimbursement. We are one of only two tests that are reimbursed—the other one is the Guardant360. But there will be others. So the differential is: We think 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- approved drugs." (continued on next page) Inivata

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