Biocartis Group NV: Genomic Health and Biocartis Expand Collaboration to Urology with the Development of an Idylla(TM) Oncotype DX Genomic Prostate Score® Test

 

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 announce they have expanded their exclusive collaboration into the field of urology with the development of an in vitro diagnostic (IVD) version of the Oncotype DX Genomic Prostate Score® (GPS(TM)) Test on Biocartis' Idylla(TM) platform and potentially additional cancer tests that can be performed locally by laboratory partners and in hospitals around the world.

Although prostate cancer is the most common cancer among men, it can fortunately often be treated successfully[1]. The Oncotype DX GPS test is the only commercially available tissue biopsy-based, multi-gene test that has been clinically validated to assess the aggressiveness of prostate cancer in men with clinically low-risk or favorable intermediate-risk cancer at the time of diagnosis, helping to make better informed and more personalized treatment decisions[2]. Today, this test has been validated in more than 4,500 patients, which is described in 18 publications[3].


The Idylla(TM) Oncotype DX GPS Test will be the first urology test to be developed on Biocartis' fully automated PCR[4]-based Idylla(TM) platform, which offers a unique sample-to-result molecular diagnostics solution. Through this development, Genomic Health intends to enable local pathology labs and urology centers to generate accurate Oncotype DX GPS test results with 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.


Herman Verrelst, Chief Executive Officer of Biocartis, commented: "I am very happy to announce the expansion of our collaboration with Genomic Health, with whom we are now entering the domain of urological cancer testing which is a promising new market for Idylla(TM). Once available, the Idylla(TM) Oncotype DX GPS test can support pathology labs and also local urology centers across the world in making better informed treatment decisions for patients with prostate cancer."


Frederic Pla, Ph.D., Chief Operating Officer, Genomic Health, continued: "Today's announcement follows the successful progress in our development of an IVD version of the Oncotype DX Breast Recurrence Score® test on Biocartis' Idylla(TM) platform that we announced last year. Expanding our collaboration to initiate development of the Oncotype DX GPS test on this fully automated sample-to-answer platform reflects our confidence in the Idylla(TM) platform as a best-in-class solution to accelerate access to Oncotype tests around the world."


The expanded collaboration will provide Genomic Health with exclusive worldwide rights to develop and commercialize its Oncotype DX Genomic Prostate Score test on the Idylla(TM) platform, with the option to expand the collaboration to include additional tests in oncology and urology. Development of the IVD version of the GPS test is expected to begin in early 2019.


As part of the agreement, Genomic Health will make a payment of EUR 2.5 million to Biocartis, which is expected to be expensed in the fourth quarter of 2018. Upon commercialization, Genomic Health will make royalty payments to Biocartis based on net sales.

Note

About Biocartis
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla(TM) platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis launched the Idylla(TM) platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology. This area represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers fifteen oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.


About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX® gene expression tests that have been used to guide treatment decisions for more than 900,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid- and tissue-based tests, including the recently launched Oncotype DX® AR-V7 Nucleus Detect(TM) test. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth, Facebook, YouTube and LinkedIn.

 

 

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