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 45 erage from Medicare is we put together the full clini- cal program and demonstrated the value of that test in practice. You have to show your analytical validation, your clinical validation, and your clinical utility. As we think about this for our first product, what we see is the chronic under testing of patients and (because of that) not making the most of the therapies that are approved. Also, patients may have already been tissue biopsied, and it has failed. Is that patient going to go through another tissue biopsy that costs about $15,000 under Medicare, and is higher under private payers? Tissue biopsy for lung cancer has a significant complica- tion rate and you still run the risk that it will fail again. Why not run a liquid biopsy that is probably, on aver- age, going to be more informative, you are not going to have complications, and you save money every time you do it? So there is a strong value argument there for private payers. We have to make those arguments, and that is part of making it on the case-by-case basis, which over time can become a coverage decision. There is a sense that payers are becoming more aware of this. They do see the value. What are the future opportunities for Inivata? Morris: We are already moving into monitoring situ- ations—patients with advanced cancer for whom we can tell whether they are responding to therapies or relapsing. We can also find some of the mechanisms of resistance, why are patients becoming resistant. That is one avenue. The other is into earlier stage cancer and detecting residual disease. When a patient has been diagnosed with early-stage cancer, they may undergo surgery that is potentially curative. Because circulating tumor DNA is cleared from the blood pretty quickly, you can use these tests a week to a month following surgery. If you can detect ctDNA at that point, you know the patient hasn't been cured and you can then guide additional therapy. In the future, these tests could become the com- panion diagnostics for adjuvant therapy. Finally, because these tests are noninvasive, we think we can produce a cost-effective test that you can use for monitoring patients. Today, generally for five years fol- lowing surgery, patients will go back to see their sur- geon or their oncologist and have CT scans, PET scans, bone scans, or other sorts of investigations to try to find evidence of recurrence. After five years, if it looks like it is all clear, the patient has been cured. Imagine if that can be done noninvasively with a blood test out in the community, much as a patient may have their cholesterol checked. They would go have a simple blood test, and if that looks clear, come back in six months and have another blood test done. The patient is only referred to the specialist center when there is evidence of recurrence. It is better for patients, less invasive, and a better quality of life not exposing them to radiation and a whole host of other things. And, of course, you are using the healthcare resources in a more efficient way. What is your model for providing this type of treatment monitoring? Morris: The strategy around the early-stage cancer, residual disease, and recurrence monitoring is to create patient-specific panels. We inform them via knowledge of that patient's genotype and make a patient-specific panel. This has two advantages: one is they become coupled with our platform sensitivity and specific- ity—they become exquisitely sensitive assays for detec- tion—and they have a relatively low cost of goods. We can actually think about how to move these into a mon- itoring setting, where the price point can be lower for reimbursement. 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." Inivata

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