Rarecells, Inc.

Rarecells Announces New Clinical Data Showing Superior Sensitivity and Tumor Heterogeneity Detection by Synergistic Combination of ctDNA and ISET® CTC-DNA in Patients with Early-Stage Lung Cancer

NEW YORK and PARIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Rarecells, a pioneer in liquid biopsy technologies, today presented new data (poster EP.06.64) at the IASLC 2025 World Conference on Lung Cancer (WCLC) in Barcelona, Spain, from its BioMolCTC Trial conducted in collaboration with Prof. Filippo Lococo’s team at Policlinico Gemelli in Rome.

Circulating Tumor Cells (CTCs) are well-established, non-invasive cancer markers, but clinical use of CTC-DNA assays has been limited by sensitivity, scalability, and practicality issues. This study presents the first clinical application of Rarecells’ next-generation ISET^® technology, redesigned to enable highly sensitive detection of tumor DNA from as few as one CTC in 10 mL of stabilized blood, while also allowing ctDNA analysis from the same sample’s plasma. The BioMolCTC Trial (NCT06546007) investigates the combined use of both biomarkers in patients with early-stage lung cancer.

The key findings demonstrate that combining ISET^® CTC-DNA with ctDNA analysis significantly enhances both sensitivity and the detection of tumor heterogeneity. Oncogenic variants were identified more often and in greater number with ISET^® CTC-DNA than with ctDNA alone, and the integration of both assays delivered the most comprehensive view—capturing tumor heterogeneity more effectively while markedly improving overall sensitivity in stage I patients.

“These results represent an important step forward in harnessing the full potential of CTC-DNA in lung cancer. With the fully redeveloped ISET^® protocol, CTC-DNA can be obtained from stabilized blood after plasma has been collected for ctDNA. The combined new approach increases sensitivity while providing a broader understanding of tumor heterogeneity,” said Prof. Patrizia Paterlini, MD, PhD, CEO and Founder of Rarecells.

“Increasing the sensitivity of liquid biopsy for early-stage lung cancer patients is truly transformational. The ability to detect tumor DNA from two independent sources from the same blood sample has the potential to provide more accurate and comprehensive information to guide earlier and more efficient therapeutic choices,” said Professor Filippo Lococo, Associate Professor at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Principal Investigator of the study.

The ongoing BioMolCTC trial will further investigate the role of combined ISET^® CTC-DNA and ctDNA in the minimal residual disease (MRD) setting.

Rarecells also plans to assess how its new approach can complement commercial ctDNA assays to provide more comprehensive diagnostic insights.

About Rarecells: Rarecells is a biotechnology company dedicated to developing and commercializing innovative liquid biopsy solutions based on its proprietary ISET^® technology. With a focus on very early cancer detection, monitoring, and personalized treatment, Rarecells aims to transform patient care through high-sensitivity, non-invasive testing.

For more information, visit www.rarecells.com or follow Rarecells at LinkedIn, X and YouTube.

Contact: media@rarecells.com