Genomic Health and Biocartis to develop IVD version of Oncotype DX

September 13, 2017 – REDWOOD CITY. Genomic Health, Inc., the world’s leading provider of genomic-based diagnostic tests  and Biocartis Group NV, an innovative molecular diagnostics company, today announced an exclusive agreement to develop an in vitro diagnostic (IVD) version of the Oncotype DX Breast Recurrence Score® test on Biocartis’ Idylla™ 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™ 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 polymerase chain reaction (PCR) -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 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 forward to making this strategic collaboration a success.”

The strategic collaboration will provide Genomic Health with exclusive worldwide rights to develop and commercialize its Oncotype DX Breast Recurrence Score test on the Idylla platform, with the option to expand the collaboration to include additional tests in oncology and urology. Development of the Oncotype DX® IVD test is expected to begin in late 2017, with the aim of providing initial access to patients in Europe, beginning with France and Germany, in 2019.

As part of the agreement, Genomic Health will make a payment of approximately $3.3 million to Biocartis, which is expected to be expensed in the third quarter of 2017. Additional payments to Biocartis will be made as certain developmental and commercial milestones are achieved in the future. Genomic Health continues to expect to be profitable for the full year 2017, excluding these transaction costs. Upon commercialization, Genomic Health will make royalty payments to Biocartis based on net sales of the IVD tests developed on the Biocartis Idylla platform.

SOURCE Genomic Health, Inc.