Delfi Diagnostics Initiates 15,000-Patient Prospective Lung Cancer Screening Trial

Clinical trial sites selected to enroll diverse populations most affected by lung cancer

BALTIMORE, May 9, 2022 /PRNewswire/ -- Delfi Diagnostics, a pioneering developer of next generation high performance, affordable liquid biopsy tests for early cancer detection, has enrolled the first participants in the CASCADE-LUNG study. CASCADE-LUNG is a prospective, multi-center trial that will enroll up to 15,000 participants at the time of their low dose CT (LDCT) lung cancer screening and will add to the clinical validation of Delfi's liquid biopsy test for lung cancer detection.

Based on USPSTF guidelines¹, annual lung cancer screening by low-dose CT scan is recommended for 15 million U.S. adults who are 50 or older and have a history of heavy smoking. However, the President's Cancer Panel said only 5% of eligible patients were screened as of 2018. The CASCADE-LUNG trial is designed to clinically validate Delfi's test to detect a blood-based signal of undiagnosed lung cancer. Researchers estimate that hundreds of thousands of deaths could be prevented world-wide through improved lung cancer early detection².

"We know LDCT can save the lives of underserved and hard to reach populations who are traditionally left behind from important medical advances," said Julie Barta, MD, the co-Principal Investigator of the CASCADE-LUNG study and Assistant Professor of Medicine at Thomas Jefferson University Hospitals and Co-Lead for the Lung Cancer, Screening and Nodules Program, a part of the Jane and Leonard Korman Respiratory Institute – Jefferson Health – National Jewish Health, and a member of the Sidney Kimmel Cancer Center – Jefferson Health. "The prospect that a procedure as routine as a blood draw could be used to improve equitable screening while reducing the number of false positives, is very exciting and could contribute to reducing lung cancer mortality in this population."

Delfi's modern liquid-biopsy platform leverages advanced, proprietary machine learning algorithms built on an efficient lab process that is easy to execute and scale. CASCADE-LUNG will complement another trial launched in 2021 that was designed to develop and validate Delfi's machine-learning based cancer detection test.

One unique aspect of the trial is involvement of many Veterans Administration hospitals, reinforcing Delfi's focus on critical populations that disproportionately suffer the ravages of lung cancer.

"We are excited to initiate this important study and honored to be working with investigators all over the country, including leading researchers at hospitals embedded in their communities such as Jefferson, and the many hospitals that serve our nation's Veterans. There are roughly 900,000 Veterans eligible for lung cancer screening and very few today are getting screened. We are eager to try and address this shortfall," said Tara Maddala, PhD, Delfi's Vice President of Clinical Development. "The results of these studies will help establish the clinical evidence to support the FDA's review of Delfi's lung cancer screening product, and also build the foundation needed for Delfi to move into new indications, such as screening for multiple cancers."

About Delfi Diagnostics 
Delfi is developing a new class of liquid biopsy tests for early detection based on altered genome-wide fragmentation profiles, also known as "fragmentomes," representing aberrant packaging of DNA in cancer cells. By applying advanced machine learning algorithms, these fragment patterns are detectable at a very low sequencing cost. Delfi is using this technology to develop highly sensitive and specific cancer detection assays intended for wide and cost-effective distribution and adoption.

SOURCE Delfi Diagnostics