PRESS RELEASE: 1 March 2018, 07:01 CET

Biocartis Establishes R&D Center in the US

Biocartis team strengthened with joining of Janssen Diagnostic’s Idylla(TM) assay development team

Mechelen, Belgium, 1 March 2018 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced that it has established an R&D center in the US to support the execution of its strategy to accelerate test menu expansion on the Idylla(TM) platform through predominantly Companion Diagnostics (CDx) collaborations and assay content partnerships. The establishment of the R&D center is the result of a transfer of R&D staff members and Idylla(TM)-related assay development assets and tests of Janssen Diagnostics (a division of Janssen Pharmaceuticals, Inc.) to Biocartis.

The assay development experts joining from Janssen Diagnostics have in-depth IVD assay development expertise on the Idylla(TM) platform and successfully developed, amongst other assays, the Idylla(TM) Respiratory (IFV-RSV) Panel, which received 510(k) clearance by the US FDA in Q3 2017.

As part of the transaction, Biocartis will pursue the anticipated assay development activities as a tenant in the team’s existing and fully equipped laboratory and office facilities, situated in Raritan, New Jersey (US), thereby managing start-up costs.

Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very pleased to be establishing this US R&D center, thanks to the support of our longstanding collaborator Janssen Diagnostics. This will help us scale our R&D organization towards the future. Also, the close proximity to many of our pharmaceutical and test content partners in the US will facilitate an efficient execution of existing and new partnerships. The Janssen Diagnostics team has demonstrated to have excellent assay development capabilities on our Idylla(TM) platform. This will allow all team members, as of day one, to add value on ongoing projects. In addition, another important advantage is that we now have access to a US pool of R&D talent that we can also tap into for future recruitment needs in light of the business growth that we aim to realize.”

As part of the agreement, approx. 10 employees (FTE[1]) will join Biocartis from the assay development expert team from Janssen Diagnostics. Furthermore, Biocartis’ subsidiary Biocartis US Inc. will lease laboratory and office space from Janssen under a two-year transitional lease and will acquire laboratory equipment and the ownership of the Idylla(TM) Respiratory (IFV-RSV) Panel will be transferred to Biocartis NV, including the regulatory authorizations. Financial details of the agreement are not disclosed. The partnership with Janssen Pharmaceutica remains in place.

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Renate Degrave

Manager Corporate Communications & Investor Relations


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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 and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers fourteen oncology tests and two infectious disease tests in Europe. More information: Press Photo Library available here. Follow us on Twitter: @Biocartis_.

Biocartis and Idylla(TM) are registered trademarks in Europe, the United States and other countries. Biocartis trademark and logo and Idylla(TM) 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.

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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, except if specifically required to do so by law or regulation. You should not place undue reliance on forward-looking statements.

[1] Fulltime equivalent.