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Idylla™ CDx biomarker test (product series)

Products Next higher product group pharmacogenomic/pharmacogenetic cancer test
Period Status 2018-01-09 
Organisation Organisation Biocartis (Group)

Biocartis Group N.V.. (1/9/18). "Press Release: Biocartis and Amgen Sign New Companion Diagnostic Agreement for Novel Oncology Compound". Mechelen.

Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced the signing of a new companion diagnostic1 (CDx) development agreement with Amgen, a leading biotechnology company (NASDAQ: AMGN), aimed at the development of Idylla™ CDx biomarker tests for a novel oncology compound to be used in the treatment of certain solid tumors.

This is the second CDx agreement that Biocartis has signed with Amgen. The first CDx agreement between both companies was announced on December 4, 2017 and aims to register the Idylla™ KRAS Mutation Test and the Idylla™ NRAS-BRAF Mutation Test with the US Food and Drug Administration (FDA) as a CDx test for Amgen’s drug Vectibix® (panitumumab).

Ulrik Cordes, EVP Companion Diagnostics of Biocartis, commented: “This new CDx agreement reinforces our strong partnership with Amgen. We are very happy to now add to this relationship a CDx co-development program supporting a novel Amgen drug compound. Today’s announcement is also an important next step in the expansion of our CDx portfolio which should contribute to short term revenue generation and create a strong pipeline of future Idylla™ CDx biomarker tests.”

Financial details on the new CDx agreement with Amgen are not disclosed.

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More information:

Renate Degrave
Manager Corporate Communications & Investor Relations
tel: +32 15 631 729
mobile: +32 471 53 60 64
Twitter: @Biocartis_

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™ 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™ platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers twelve oncology tests and two infectious disease tests in Europe. More information: Press Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. Biocartis trademark and logo and Idylla™ trademark and logo are used trademarks belonging to Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

This press release may contain forward-looking statements. Such forward-looking statements are not guarantees of future performance. These forward-looking statements speak only as of the date of this press release. Biocartis expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release. You should not place undue reliance on forward-looking statements.

1A CDx test is a test used as a companion to a therapeutic drug that helps predict if a patient is likely to respond to a treatment or not.

Record changed: 2020-09-04


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