Nucleix Demonstrates Potential of its PCR EpiCheck® Assay to Accurately Differentiate Between Small Cell Lung Cancer (SCLC) Subtypes

Data presented at the American Association for Cancer Research (AACR) Annual Meeting 2024

SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from a pilot study demonstrating the potential of a simple PCR assay based on EpiCheck^® technology to accurately differentiate between small cell lung cancer (SCLC) subtypes. The Company is presenting the data in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, April 5-10.

The 13-marker PCR assay developed for this pilot study stemmed from data from a recent study published in Cancer Cell demonstrating the detection of SCLC using DNA methylation in plasma samples from heavy smokers, yielding a sensitivity of 94% and specificity of 95%. Based on the strength of these results, Nucleix collaborated with The University of Texas MD Anderson Cancer Center to develop novel biomarkers for the classification of SCLC into subtypes to reduce time between diagnosis and tailored treatment interventions. In the data being presented at AACR, the 13-marker PCR assay correctly classified 97% of the SCLC tissue samples in a blinded cohort.

“For decades, SCLC was considered a single, monolithic entity resulting in our current clinical protocols being based on disease stage, with no consideration of biomarkers that have predictive or prognostic significance, leading to expectedly poor outcomes,” said Mathias Ehrich, M.D., chief scientific officer. “These data show that we can potentially reduce the time between patient diagnosis and initiation of tailored treatment or inclusion in clinical studies from a month, in best-case scenarios, to just a few days, by using our PCR EpiCheck-based assay for the classification of SCLC subtypes.”

Details of the AACR presentation are as follows:

Title: “Subtype classification of small cell lung cancer (SCLC) tissues using the EpiCheck methylation sensitive restriction-based PCR platform”
Session Title: Epigenetic Targets in Oncology
Session Date and Time: Monday, April 8, 9:00 AM – 12:30 PM PT
Session Type: Poster Presentation
Abstract / Poster Number: 1722 / 7

About Nucleix

Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients. Leveraging NGS-based and PCR-based technology to identify methylation changes, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck^® delivers highly accurate and sensitive results, all while providing a seamless testing option for physicians, patients, and the healthcare system. The Company is building an EpiCheck franchise, beginning with the Bladder EpiCheck^® kit, CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. The Company is advancing its Lung EpiCheck^® test towards commercialization for high-risk individuals, while evaluating additional tests for other high-risk diseases. For more information, please visit: https://www.nucleix.com.

NUCLEIX, the NUCLEIX Logo, EPICHECK, LUNG EPICHECK and BLADDER EPICHECK are trademarks or registered trademarks of Nucleix Ltd.