Nivolumab

PRESS RELEASE - 09/15/2025, 09:00 AM EDT Biocartis Receives FDA Approval for the Idylla™ CDx MSI Test First-ever fully automated, sample-to-result, cartridge-based companion diagnostic test approved in the US for colorectal cancer patients Itasca (IL), United States, 15 September 2025 – Biocartis Group of Companies (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ CDx MSI Test developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the FDA for a cartridge-based, fully automated, “sample-to-result” companion diagnostic test. The Idylla™ CDx MSI Test aids in identifying eligible microsatellite instability-high (MSI-H) colorectal cancer (CRC) patients, who may benefit from treatment with OPDIVO® (nivolumab) alone, or in combination with YERVOY® (ipilimumab), as established in the CheckMate-8HW trial (Bristol Myers Squibb Company) (André et al., 20241; André et al., 20252)3. “The approval of this new MSI companion diagnostic for patients with colorectal cancer is a meaningful achievement from our collaboration with Biocartis and a strong reflection of our Precision Medicine strategy at Bristol Myers Squibb,” said Sarah Hersey, Vice President, Precision Medicine, Bioanalytical and Translational Sciences, Bristol Myers Squibb. “Rapid and accurate diagnosis is crucial to enabling access to appropriate therapeutic approaches, and this latest advancement exemplifies our commitment to delivering innovative, targeted solutions that have the potential to improve outcomes for patients.” Designed for use on the Idylla™ Platform, the Idylla™ CDx MSI Test qualitatively detects a panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for detection of MSI in CRC tissue samples. The Test runs in a single-use cartridge, requiring less than three minutes of hands-on-time and delivering straightforward results in under three hours. “Achieving FDA approval for our Idylla™ CDx MSI Test represents a key milestone for Biocartis," said Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis. “It underscores our commitment to helping oncology patients receive the right therapy without delay and the recent CheckMate-8HW data reinforce the critical importance of accurate MSI-H/dMMR testing in colorectal cancer. With its speed, accuracy, and automation, the Idylla™ CDx MSI Test offers a powerful solution that enables clinicians to make timely, confident and data-driven treatment decisions when every moment counts.” The Idylla™ CDx MSI Test will be made available across the US soon, with availability in other non-US markets expected to follow. For more information about the Test, please visit the Biocartis website or contact the Biocartis team. ----- END ----- More information: Biocartis NV. Generaal De Wittelaan 11B, 2800 Mechelen, Belgium Biocartis US Inc. 2 Pierce Place, Suite 1510, Itasca, IL 60143, US www.biocartis.com | info@biocartis.com About Biocartis Biocartis is committed to helping cancer patients worldwide access the right treatment faster. With our proprietary Idylla™ Platform, we deliver in-house molecular biomarker results in only 3 hours, enabling healthcare professionals to make timely, informed decisions that guide personalized therapy. Our expanding portfolio of diagnostic tests and research assays addresses key unmet clinical needs across multiple cancers, including lung, skin, thyroid, colorectal, endometrial, blood, brain, and breast cancer. Learn more at www.biocartis.com and follow us on LinkedIn, Facebook and X (Twitter). Disclaimers Idylla™ Platform is CE-marked in Europe in compliance with EU IVD Regulation 2017/746, listed as a class II device in the US under establishment registration 3009972873, and registered in many other countries. Idylla™ CDx MSI Test (A0220/6) is approved in the US under P250005. Biocartis and Idylla™ are registered trademarks in Europe, the US and many other countries. The Biocartis and Idylla™ trademarks and logos are used trademarks owned by Biocartis NV. OPDIVO® and YERVOY® are registered trademarks of Bristol Myers Squibb Company. © September 2025, Biocartis NV. All rights reserved. 1 Andre, T. et al. (2024). Nivolumab plus Ipilimumab in Microsatellite-Instability-High Metastatic Colorectal Cancer. The New England journal of medicine, 391(21), 2014–2026. https://doi.org/10.1056/NEJMoa24021412 Andre, T. et al. (2025). Nivolumab plus ipilimumab versus nivolumab in microsatellite instability-high metastatic colorectal cancer (CheckMate 8HW): a randomised, open-label, phase 3 trial. The Lancet, 405(10476), 383–395. https://doi.org/10.1016/S0140-6736(24)02848-43 Please see U.S. Full Prescribing Information for OPDIVO and YERVOY.

The FDA has granted premarket approval to Biocartis and Bristol Myers Squibb for their jointly developed companion diagnostic designed to identify patients with microsatellite instability-high (MSI-H) colorectal cancer (CRC) who may benefit from treatment with BMS' PD-1 inhibitor Opdivo (nivolumab) alone or in combination with its CTLA-4 inhibitor Yervoy (ipilimumab). The Idylla CDx MSI Test is the first cartridge-based, fully automated "sample-to-result" companion diagnostic to receive this designation.The test runs on the Idylla Platform, Biocartis' fully-automated, real-time polymerase chain reaction (PCR)-based molecular diagnostics system. It qualitatively detects seven monomorphic biomarkers — ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2 — all associated with MSI in colorectal cancer tissue samples. Unlike traditional PCR methods, it does not require matched normal tissue. The single-use cartridge requires under three minutes of hands-on time and returns results in less than three hours.In the Checkmate-8HW trial, presented at ASCO 2025, first-line treatment with Opdivo and Yervoy achieved a two-year progression-free survival rate of 72% versus 14% for chemotherapy in patients with MSI-H unresectable or metastatic CRC identified using the Idylla CDx MSI Test. The study also found that 13% of patients were classified as proficient mismatch repair/microsatellite stable upon central testing, highlighting the test's value in accurately selecting patients most likely to benefit from immunotherapy."Achieving FDA approval for our Idylla CDx MSI Test represents a key milestone for Biocartis," said Michael Korn, chief medical and scientific officer at Biocartis. "It underscores our commitment to helping oncology patients receive the right therapy without delay and the recent CheckMate-8HW data reinforce the critical importance of accurate MSI-H/deficient MMR testing in colorectal cancer."Biocartis and BMS initiated their partnership in 2019 to pursue regulatory approval of the Idylla MSI test as a companion diagnostic for immuno-oncology treatments. While initially focused on US registration for metastatic CRC, the companies expanded their collaboration in 2020 to include regulatory efforts in China. The approval reflects BMS's precision medicine strategy, said Sarah Hersy, VP of precision medicine, bioanalytical and translational sciences at BMS. "Rapid and accurate diagnosis is crucial to enabling access to appropriate therapeutic approaches, and this latest advancement exemplifies our commitment to delivering innovative, targeted solutions that have the potential to improve outcomes for patients," she added.Biocartis expects the Idylla CDx MSI test to become available in the US soon, with international markets to follow.