Nucleix’s Lung EpiCheck ® Liquid Biopsy Test Detects 85% of Early Stage Lung Cancers in High-Risk Smokers, Study Published in European Respiratory Journal

Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced a publication showing its Lung EpiCheck® test detected 85% of early stage lung cancers among individuals at high risk for developing the disease based on their history of smoking. The study, entitled “Validation of Lung EpiCheck®, a novel methylation-based blood assay, for the detection of lung cancer in European and Chinese high-risk individuals,” was published online today ahead of print in the European Respiratory Journal (ERJ).

Lung EpiCheck analyzed 728 different samples in the study, including 311 from individuals with varying stages of lung cancer and 417 matched controls. By adjusting measurement of six methylation markers found in blood, the test was tailored to meet the needs of specific patient populations: increased sensitivity for high-risk populations, or increased specificity for low-risk populations. When focused on increased sensitivity for a high-risk population of past and current smokers, Lung EpiCheck demonstrated an overall sensitivity of 87% detection of lung cancer across all stages, 85% detection of Stages I-IIIA non-small cell lung cancer (NSCLC) and 78% detection of Stage I NSCLC, each with a specificity of 64%. The test also detected 100% of small cell lung cancer, a rapidly growing and deadly cancer that is typically challenging to detect. When focused on increased specificity for a low-risk population, Lung EpiCheck demonstrated overall specificity of 91% and sensitivity of 74%. Combining Lung EpiCheck with established risk factors improved the AUC, the ability to distinguish between patients with and without disease, from 88% to 94%.

“In the United States, very few high-risk individuals follow the recommended screening guidelines of annual, low-dose CT scans. Offering a highly sensitive test to those who decline to undergo the recommended scan gives them a better chance for early detection, while a false positive would simply result in proceeding to the current standard of care,” said Chris Hibberd, chief executive officer of Nucleix. “We are taking steps to further advance Lung EpiCheck as a low-cost blood test to encourage more patients to comply with recommended screening.”

Lung cancer is the deadliest cancer, with 1.76 million deaths worldwide in 2018.¹ Survival hinges on early detection, with 5-year survival rates nearly 10 times greater for Stage I cancer than Stage IV cancer.² The U.S. Preventive Services Task Force recommends annual screening with low-dose computed tomography (also called a low-dose CT scan, or LDCT) for current and past smokers at the highest risk of developing lung cancer – specifically, those individuals age 55-80 who have smoked an average of one pack of cigarettes a day for more than 30 years and currently smoke, or who quit, within the past 15 years.³ Even though there is no cost to these individuals to receive a LDCT scan, and it has been shown to improve survival,⁴ only 7%⁵ to 14%⁶ of those eligible in the United States follow this guideline due to a combination of inconvenience, missing infrastructure and fear of radiation exposure.

“Lung cancer is most often diagnosed at late stages when chances of cure are limited,” said Prof. Mina Gaga, Director and Head, 7^th Respiratory Medicine Department, Athens Chest Hospital and the principal investigator of the study. “Tests for early diagnosis are urgently needed and the Lung EpiCheck data published in the ERJ show important promise for the implementation of lung cancer screening.”

Nucleix is continuing to optimize the Lung EpiCheck test and is advancing development of next-generation versions, with a goal of making a test available within 1 to 2 years.

About Lung EpiCheck®

Lung EpiCheck is designed to provide a simple blood test to detect lung cancer at its earliest stages. The test utilizes PCR-based technology for a low-cost analysis of subtle, disease-specific changes in DNA methylation markers. Lung EpiCheck is being developed for potential use in individuals with a history of smoking who are at high-risk of developing lung cancer, and do not comply with the guidelines for annual screening with LDCT scans. The test is not yet commercially available.

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 PCR-based epigenetics, the Company’s pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. The Company’s non-invasive EpiCheck® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. The Company is building an EpiCheck franchise, beginning with the Bladder EpiCheck testing kit, marketed in Europe for bladder cancer recurrence. The Company is advancing a Lung EpiCheck test toward commercialization for high-risk individuals, while advancing additional tests for high-risk diseases. For more information, please visit: https://www.nucleix.com.

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¹ GLOBOCAN2018 Global Cancer Observatory http://gco.iarc.fr.
² Lung cancer Stat Facts: Lung and Bronchus Cancer. https://seer.cancer.gov/statfacts/html/lungb.html entered October 2020.
³https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening
⁴ NEJM Research team. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med 2011;365:395-409.
⁵ LCSR Available Facility Reports. (n.d.). Retrieved October 28, 2020, from https://nrdrsupport.acr.org/support/solutions/articles/11000039783-lcsr-available-reports
⁶ Zahnd WE, Eberth JM. Lung cancer screening utilization: A behavioral risk factor surveillance system analysis. Am J Prev Med. 2019;57:250-255. doi: 10.1016/j.amepre.2019.03.015.

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