Press Release Biocartis NV: Biocartis to Present Initial Development Data for Ultra-Rapid Idylla™ Breast21 Assay at SABCS 2026
PRESS RELEASE, October 30, 2026 – 08:00 CDT Biocartis to Present Initial Development Data for Ultra-Rapid Idylla™
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PRESS RELEASE, October 30, 2026 – 08:00 CDT
Biocartis to Present Initial Development Data for Ultra-Rapid Idylla™ Breast21 Assay at SABCS 2026
ITASCA, IL, US – October 30, 2026. Today, Biocartis, an innovative molecular diagnostics company, announced that an abstract on its Idylla™ Breast21 Assay1 has been accepted for poster presentation at the San Antonio Breast Cancer Symposium (SABCS), taking place 8-11 December 2026 in San Antonio, Texas, US.
The poster, entitled “An ultra-rapid, fully automated 21-gene RT-PCR assay for decentralized recurrence risk testing: concordance with an established genomic risk score in early-stage breast cancer2”, presents initial development data for the Idylla™ Breast21 Assay, including training and testing data.
The established 21-gene Recurrence Score is a widely validated genomic signature providing prognostic and predictive information in hormone receptor-positive, HER2-negative early-stage breast cancer. However, testing currently relies on centralized laboratory services, which can add time to the treatment decision-making process and may limit access to testing in some settings. The Idylla™ Breast21 Assay is being developed as an ultra-rapid, fully automated and decentralized alternative that measures RNA expression of the same 21 genes from FFPE tissue to deliver a recurrence-risk score.
Initial development data show strong risk class agreement between the Idylla™ Breast21 Prototype Assay and the reference method. The study design and these findings will be presented in detail at SABCS.
“These initial development data are an encouraging step for the Idylla™ Breast21 Assay. The strong agreement with a well-established 21-gene assay, combined with a fully automated workflow that delivers a result in less than 4 hours in a decentralized fashion, shows the potential to bring reliable genomic recurrence-risk testing closer to the patient”, said W. Michael Korn, M.D., Chief Medical and Scientific Officer at Biocartis.
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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™ System, 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.
Disclaimers
Idylla™ System 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. Biocartis and Idylla™ and their respective logos are trademarks and registered trademarks of Biocartis NV in the US and other jurisdictions. © October 2026, Biocartis NV. All rights reserved.
1 Under development.
2 Declercq, M., Roberfroid, S., De Craene, B., Yaziji, H., Alloush, F., Poppiti, R., Vail, E., Barrena, B., Leong, M.C. , Vankerckhoven, E., Ivens, T., Pollet, N., Gilliaert, K., Kalkantzis, G., Bollen, L., Taniere, P., Goetz, M.P., Wuyts, J., Metsu, S., Korn, W.M. (2026)
