Clinical OMICS

JAN-FEB 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 January/February 2019 Clinical OMICs 15 Getting the Earliest Start To combat the difficulties of getting a new CDx online with a ref- erence lab and ready to go as soon as the drug and diagnostic receive regulatory approval, Qiagen has launched what it calls its Day-One program. Under this initiative, the company partners with diagnostics labs ahead of regulatory approval, providing the lab with investigational use only versions of the diagnostic. Qiagen announced one such partnership in late November, with cancer genetics testing company NeoGenomics. "Together with our Pharma partners, we are now planning to provide inves- tigational use only (IUO) tests to NeoGenomics, enabling them to verify and set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval," said Qiagen CEO Peer Schatz in announcing the deal. "The companion diagnostic services can be provided by NeoGenomics once FDA approval has been obtained, facilitating the rapid adoption of innovative targeted therapies." The arrangement breaks the mold of waiting until a CDx has been approved to be- gin to arrange its placement with reference labs. But the idea, as the program name suggests, is to create a frame- work with alignment between the pharmaceutical company, Qiagen, and testing labs to acceler- ate commercial deployment of the CDx and the approved drug— what Schatz calls "synchronized launches of new oncology drugs." While a program like Day-One makes sense for Qiagen's phar- ma partners, getting the diagnostic provider to hop on board be- fore the CDx is approved can takes convincing, said Jonathan Ar- nold, head of next-generation diagnostics marketing at Qiagen. "When they make the decision to begin investing in a test, they need to make a return," noted Arnold. "So that is one of the barriers we've had to overcome rolling out this model. We ask them to take the risk with us and we will share some of the risk." What time is best to start the process? "When we approach [a testing company], we are highly confident the test is coming—we can't guarantee it—but we believe it is coming," Arnold said. A more standard approach to working with labs to take on a newly approved CDx can delay running of the first test by as much as nine months, Arnold said, while the testing lab gears up, in- vests in equipment, and validates the test in its own environment. This lag in test availability "hurts the patients, hurts the pharma partner, hurts Qiagen, and hurts the lab because there is a win- dow where that test isn't available in the market," he concluded. —Chris Anderson. n ad's BRACAnalysis CDx was approved with AstraZeneca's Lynparza for certain ovarian cancer indications. "Within a month of the FDA approval, the NCCN guidelines were updated to indicate the approval of the drug, elaporib (Lyn- parza) and the companion diagnostic. But in the guidance, [NCCN] said it should be used for patients who have under- gone testing with an FDA-approved companion diagnostic or a CLIA approved test," Lancaster said. "So instantly all of that time and effort and investment to get an FDA-approved test went out the window because NCCN was saying you can use any old CLIA test." From Anderson's perspective, some of the difficulty for a test like BRACAnslysis CDx, originally approved in late 2014, arose from the new paradigm of having a specific test for a specific set of cancer patients. "If you go back and look at the first couple of examples of a companion diagnostic, that was new territory for patholo- gists and oncologists," Anderson noted. "This is starting to become more routine for both the pathologists and oncolo- gists, so that awareness has increased." But there is still work to be done. Anderson believes that while awareness is high among academic medical centers and comprehensive cancer centers, oncologists in the community setting are still getting up to speed. Ron Rogers, spokesper- son for Myriad, highlights this need. "If you look at ovarian cancer as an exam- ple, essentially every single woman with ovarian can- cer would meet guidelines for use of a companion diangostic for the potential use of PARP inhibitors," he said. "We know that a majority of ovarian cancer patients haven't been tested. So why is that? I think it is that we need to do a better job of raising awareness." Jonathan Lancaster, M.D., chief medical officer, Myriad Genetics "Usually diagnostics companies approach payers when they have completed their clinical validation and when they have already launched onto the market." —Hannah Mamuszka, CEO, Alva10 Jonathan Arnold, Qiagen

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