TEST:

Lung EpiCheck®

Whole blood was collected prior to any cancer treatment and processed into plasma. cfDNA was extracted from plasma, then exposed to methylation restriction specific digestion and then sequenced at a depth of 50x (Lung EpiCheck, Nucleix Inc, San Diego).

"Nucleix...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....In the data being presented at AACR, the 13-marker PCR assay correctly classified 97% of the SCLC tissue samples in a blinded cohort."

DNA methylation has emerged as a prominent cancer biomarker, with MSRE digestion followed by qPCR or next-generation sequencing serving as robust methods for methylation analysis. Our results demonstrate that mitochondrial DNA can function as an ideal intrinsic MSRE digestion control due to its abundance and disease-agnostic digestibility. When incorporated into qPCR assays, this internal control can not only detect but also potentially correct digestion-related analytical noise, enhancing the accuracy and reliability of clinical liquid biopsy (LBx) diagnostics in cancer and beyond.

"Nucleix...announced recent updates in its lung cancer detection program for early-stage disease...At the American College of Chest Physicians (CHEST) 2023 Annual Meeting...presented initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck®."

"Nucleix...announced that new data from the Sightline study of Lung EpiCheck^® will be presented by Dr. Peter Mazzone from Cleveland Clinic in a late-breaking rapid-fire original investigations session during the American College of Chest Physicians (CHEST) 2023 Annual Meeting, October 8-11 in Honolulu. The presentation will showcase initial performance data from the Sightline study, a prospective multi-center, case-control study evaluating the performance of Lung EpiCheck, a non-invasive test to aid in the detection of early-stage lung cancer in high-risk patients."

Our preliminary findings show the potential of Lung EpiCheck to detect early-stage lung cancer with high sensitivity. An independent validation of these results is underway. CLINICAL IMPLICATIONS: A blood test able to detect early-stage lung cancer with high sensitivity could improve implementation and effectiveness of lung cancer screening.

"Presentations will highlight company’s multiomic, genome-wide discovery platform with methylation at its core, to identify blood-based biomarkers focused on early-stage lung cancer detection...Nucleix...will premiere data from its early lung cancer detection discovery platform, the Nucleix EpiCheck® Lung Atlas, at the American Association for Cancer Research (AACR) Annual Event in Orlando, April 14-19. The proprietary Lung Atlas was constructed and developed as part of a multi-institutional effort to map epigenetic and genomic changes associated with early-stage lung cancer, particularly stage I disease."

"Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, announced recent advances in its EpiCheck® Next Generation Sequencing (NGS) platform and lung cancer detection program for early stage disease...While EpiCheck revealed many promising markers that are indicative of early-stage disease, the bisulfite approach only identified 1% of what EpiCheck detected. This result strengthens our belief that the EpiCheck technology sees biology that other approaches miss."

Lung EpiCheck demonstrated strong performance in lung cancer prediction in case-control European and Chinese samples, detecting high proportions of early stage NSCLC and SCLC and significantly improving predictive accuracy when added to established risk factors. Prospective studies are required to confirm these findings. Utilising such a simple and inexpensive blood test has the potential to improve compliance and broaden access to screening for at-risk populations.

No abstracts available