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Genomic Health and Biocartis Announce Agreement to Develop an Idylla(TM) IVD Oncotype DX® Breast Cancer Test to Broaden Global Patient Access

14 Sep 17

 Genomic Health, Inc., the world's leading provider of genomic-based diagnostic tests (NASDAQ: GHDX) and Biocartis Group NV, an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced an exclusive agreement to develop an IVD version of the Oncotype DX Breast Recurrence Score® test on Biocartis' Idylla(TM) platform that can be performed locally by laboratory partners and in hospitals around the world. 

The Oncotype DX Breast Recurrence Score test examines the activity of 21 genes in a patient's breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. As the only test proven to predict chemotherapy benefit, the Oncotype DX Breast Recurrence Score test is included in all major cancer guidelines worldwide and is now considered standard of care for early-stage breast cancer.

Biocartis' proprietary Idylla(TM) platform offers a unique solution that is currently unmatched in the localization of complex molecular diagnostics.  With the fully automated sample-to-answer, real-time PCR[1]-based cartridge of the Idylla platform, Genomic Health intends to enable local pathology labs to generate Oncotype DX Breast Recurrence Score results with minimal labor, efficient turnaround time, and the consistent high quality and clinical utility that physicians and patients have come to expect when making treatment decisions with Oncotype DX.

"We are excited to augment our successful U.S. centralized laboratory business model with an IVD system that can be implemented by local laboratories to increase global patient access to standard of care testing with the Oncotype DX Breast Recurrence Score test planned for launch in Europe beginning with France and Germany in 2019," said Frederic Pla, Ph.D., chief business and product development officer, Genomic Health. "We believe our strategic collaboration with Biocartis positions us to accelerate adoption and market access around the world, as well as to broaden partnership opportunities with pharmaceutical companies seeking diagnostic solutions with the ability to develop and offer tests globally through decentralized settings."

Herman Verrelst, chief executive officer of Biocartis, commented: "Adding world-leading assays such as the Oncotype DX test to our Idylla platform is an essential step in our strategy to rapidly expand the menu offering on our platform. Today's announcement demonstrates how we can assist providers of proprietary molecular tests in making their offering available to local labs across the globe, without the need for a highly specialized molecular diagnostics infrastructure. This demonstrates the true strength and ambition of the Idylla(TM) technology: enabling the best molecular diagnostics for all patients, worldwide. We are impressed by what Genomic Health has realized so far and our team looks forw

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