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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36 Clinical OMICs July/August 2019 www.clinicalomics.com Q IAGEN has been among the busiest companion diagnos- tics developers this year. On May 24, QIAGEN launched its therascreen PIK3CA RGQ PCR Kit following FDA approval as a CDx for identifying breast cancer patients eligible for treatment with Novartis' Piqray (alpelisib). Eight days earlier, QIAGEN and Inovio Pharmaceuticals agreed to co-develop a CDx for Inovio's DNA-based immunotherapy candidate VGX- 3100 to treat cervical dysplasia caused by human papillomavi- rus (HPV). And in April, QIAGEN launched therascreen FGFR RGQ RT-PCR Kit as a CDx with Janssen Biotech's approved FGFR kinase inhibitor Balversa (erdafitinib). Following more than a decade of partnering with biophar- mas, QIAGEN has developed companion diagnostic assays for seven FDA-approved therapies. The company says it is collaborating with more than 25 companies to develop and commercialize CDx assays. "Such a deep pipeline of experience and expertise allows QIAGEN to act as true consultants ensuring the best solu- tions for our partners," Reinhard Ortmann, Ph.D., QIA- GEN's director of companion diagnostic development, told Clinical OMICs. "We uniquely offer both real-time PCR and NGS-based companion diagnostic development within a complete Sample to Insight workflow. We are able to align drug and diagnostic development to achieve simultaneous approval, and we can even provide pharma global clinical trial sample testing." QIAGEN serves and supports more than 500,000 labs in more than 35 countries, with distributors in 70 countries. Ortmann said QIAGEN is well-positioned to develop a global lab network strategy and prepare reference labs for CDx readiness at time of drug launch. "At QIAGEN, we accelerate the development, validation, and commercialization of companion diagnostics so that labs can implement patient testing the same day the drug gains approval," Ortmann said. QIAGEN's Day-One Lab Readiness program builds on the FDA's updated regulatory approach designed to help iden- tify patients who might benefit from a new treatment option earlier, saving valuable time and money, Ortmann added. T hermo Fisher Scientific's Oncomine Dx Target Test anchors the company's companion diagnostic effort, part of a specialty diagnostics business segment whose rev- enue rose 7% last year, to $3.72 billion. In 2017, the company became the first to win FDA approval for a multi-marker, NGS-based CDx oncology test when Oncomine Dx was authorized for simultane- ously screening tumor samples for biomarkers associated with three FDA-approved therapies for non-small cell lung cancer (NSCLC)—AstraZeneca's Iressa (gefitinib), Pfizer 's Xalkori (crizotinib), and Novartis' combination of Tafinlar (dabrafenib) and Mekinist (trametinib). Since then, Oncomine Dx Target Test has been improved to simultaneously evaluate 46 cancer-driver gene variants using as little as 10 nanograms of DNA and RNA. Oncomine Dx Target Test has been CE-IVD marked in Europe and also received regulatory approval in South Korea and Japan. On February 27, Japan's Ministry of Health, Labour, and Wel- fare granted expanded approval to include three additional NSCLC biomarkers that have a total of eight associated tar- geted therapies. "This milestone has led to several signed CDx develop- ment agreements with major pharmaceutical companies that want to leverage our Oncomine Dx Target Test as a CDx for certain targeted therapies in their pipeline. We also have multiple partners in China that enable both clinical trials and CFDA-approved assays to be developed for that mar- ket," said Andy Felton, vice president of product manage- ment, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. Felton said experience with global regulatory bodies is one key factor Thermo Fisher cites for its success in CDx; the other is the company's global presence. "Our comprehensive regulatory, development, reim- bursement, go-to-market expertise, and global commercial footprint allows for a fast and reliable path for any drug developer to gain a CDx approval and commercialize with maximum impact," Felton added. ANDY FELTON VP Product Management, Clinical NGS and Oncology REINHARD ORTMANN Director of Companion Diagnostic Development

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