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Genomic Health, Biocartis to Develop IVD Version of Oncotype DX

NEW YORK (GenomeWeb) – Genomic Health and Biocartis announced today that they have entered into an exclusive agreement under which they will develop an in vitro diagnostic version of Genomic Health's Oncotype DX breast cancer test on Biocartis' Idylla platform.

Under the terms of the agreement, Genomic Health will gain exclusive worldwide rights to develop and commercialize its Oncotype DX Breast Recurrence Score test on Idylla, with the option to expand the collaboration to include additional tests in oncology and urology. Unlike Genomic Health's current laboratory developed tests, which users have to send out to the company's central lab, the new IVD would allow customers to perform the Oncotype DX assay locally in their own facilities.

The Oncotype DX Breast Recurrence Score measures the activity of 21 genes in patients' tumor tissue, providing a score that indicates risk of recurrence and helping to guide decisions about whether to use adjuvant treatment. Biocartis' Idylla platform provides a fully automated sample-to-answer, real-time PCR cartridge system that Genomic Health believes will allow it to offer IVD customers efficient turnaround time and high quality results.

Genomic Health will make a payment of approximately $3.3 million to Biocartis, which it expects to expense in the third quarter of 2017.  Genomic Health will also make additional payments as specific developmental and commercial milestones are achieved, and will make royalty payments to Biocartis, based on net sales of the test after commercialization.

"We are excited to augment our successful US centralized laboratory business model with an IVD system that can be implemented by local laboratories to increase global patient access," Genomic Health Chief Business and Product Development Officer Frederic Pla said in a statement.

Genomic Health's plan is to launch the breast cancer IVD in Europe, beginning with France and Germany in 2019, Pla noted. Development of the test will begin later this year.

Although Genomic Health has made progress in gaining payment for the LDT version of Oncotype DX internationally, having a product more suited for Europe's decentralized lab model may help it compete more aggressively with other assays like Nanostring's Prosigna and Myriad Genetics' EndoPredict.

For Biocartis, the partnership with Genomic Health will advance the firm's larger strategy of rapidly expanding the menu of Idylla offerings, CEO Herman Verrelst added. Currently, the installed base for the Idylla system is close to 500 instruments.