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 37 F rom its inception in 2006, the mission of Molecu- larMD, an ICON plc company, has been to empower therapeutic/diagnostic co-development with strategies that mitigate risk and that nimbly adapt to accelerated approval timelines. MolecularMD—acquired by ICON earlier this year— cites capabilities that include combining technical expertise with proven end-to-end capabilities in development and approval of therapeutics and diagnostics for oncology preci- sion medicine. The company can develop and manufacture a test both independently with drug sponsor and through three-way partnerships with drug sponsors and IVD/plat- form partners. "MolecularMD's distinction is premised on the fact that diagnostic strategies and challenges for each therapeutic program are unique and often change course with limited notice," MolecularMD President Dan Snyder told Clinical OMICs. "The ideal diagnostic partner needs to excel in tech- nical, clinical, quality, regulatory, and commercial diagnostic competencies while collaboratively planning and navigat- ing the translational, clinical, and commercial phases of the therapeutic program." The company's MRDx BCR-ABL Test was authorized by the FDA in 2017 as a CDx for treatment-free remission in Philadelphia chromosome positive (Ph+) chronic myeloid leukemia patients in the chronic phase being treated with Novartis' Tasigna (nilotinib). Last year, MolecularMD signed a non-exclusive collaboration agreement with Sys- mex toward CDx development and commercialization. Factors in MolecularMD's success, Snyder said, include its experience in drug-diagnostic co-development, and its scientific and development expertise. "Our organizational structure and supporting processes allow for rapid development and deployment of 'fit for pur- pose' tests, ranging from RUO, CTA, IUO, and IVD for both tissue and plasma-based assays. MolecularMD also acts as a central laboratory testing partner so we can develop and deploy a test in rapid succession," Snyder said. "For post approval, MolecularMD retains an experienced team dedi- cated to planning and execution of IVD commercialization, including programs to support U.S. reimbursement and global distribution. And now, with MolecularMD being part of ICON, we have greater breadth and depth in what we are able to offer our clients." CINDY PERETTIE CEO DAN SNYDER President F oundation Medicine achieved its first key companion diagnostics approval in November 2017 when its Foun- dationOne CDx won the FDA's first market authorization for a comprehensive genomic profiling assay for all solid tumors incorporating multiple tests. The following June, majority owner Roche spent $2.4 billion to expand its stake into full ownership of the cancer-focused molecular diag- nostics developer, in a deal that signaled the pharma giant's growing interest in personalized oncology treatments as well as diagnostics. Foundation Medicine—now a separate and autonomous company within the Roche Group—says its portfolio of com- prehensive genomic profiling (CGP) tests, robust genomic data and insights, and strong network of physicians uniquely posi- tions the company well for partnering with drug developers. In May, Foundation Medicine and Bayer launched a global collaboration to develop and commercialize NGS-based companion diagnostics across multiple oncology drug can- didates and approved therapies developed by Bayer. The deal covers FoundationOne CDx and the rest of Foundation Medicine's test portfolio, which includes the FoundationOne Heme test for hematologic malignancies and sarcomas, and Foundation One Liquid, a liquid biopsy test for solid tumors launched last year as a next-gen version of FoundationACT. Foundation Medicine's commitment to providing phy- sicians and partners with a rigorously-validated portfolio of CGP tests is a key factor in the company's success, CEO Cindy Perettie told Clinical OMICs. "We're proud to collaborate with more than 50 biophar- maceutical companies to help drive precision medicine for- ward in pursuit of better outcomes for patients," Perettie said. "Our partners depend on the rigor and comprehen- siveness of our genomic tests, robust real-world data and our commitment to continued innovation to achieve more efficient therapy development.

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