Freenome Initiates PROACT LUNG Clinical Study for the Early Detection of Lung Cancer Using Blood Test Developed on Multiomics Platform

– Registrational study targets enrollment of 20,000 individuals at high risk of lung cancer –

SOUTH SAN FRANCISCO, Calif., Dec. 12, 2023 /PRNewswire/ -- Freenome, a privately held company developing multiomics blood tests for early cancer detection, today announced the initiation of its PROACT LUNG study and provided an update on its lung cancer research, including the ongoing Vallania study. The study is intended to validate the clinical performance of the Freenome blood test for lung cancer screening. The test combines lung cancer-specific biomarkers with cancer-common markers identified on Freenome's proprietary multiomics platform. This is Freenome's second blood-based test developed on the platform and being evaluated in a prospective clinical study.

Early detection of lung cancer, while in its most treatable stage, leads to better clinical outcomes for patients.^1,2 Recently, the United States Preventive Services Task Force expanded the recommended ages and smoking history for lung cancer screenings, reaffirming the importance of early detection. In people at high risk for lung cancer, annual screening with a low-dose CT (LDCT) scan is typically recommended as part of the standard of care (SOC). However, only about 5.8% of eligible people are screened for lung cancer,³ with fewer than 25% of them adhering to recommended annual screenings.⁴ LDCT also has drawbacks, including the potential of exposing patients to unnecessary radiation⁵ and false-positive rates that range from 9% to 50%.^2,6

Foundational to Freenome's scientific approach is the knowledge that no single technology can detect every cancer due to the intrinsic heterogeneity of the disease. Freenome's multiomics blood-based screening platform, research programs, and clinical studies continuously enrich insights into the molecular underpinnings and commonalities across cancer types. In turn, this knowledge is used to enhance screening capabilities.

"Despite treatment advances, lung cancer remains the deadliest cancer worldwide, in part because it is often detected late. Freenome is answering the call for better screening tools with a test that identifies the diverse range of biomarkers associated with this highly heterogeneous cancer," said Lance Baldo, M.D., chief medical officer of Freenome. "Our expanding healthcare partnerships will increase access to these improved tools."

About PROACT LUNG

PROACT LUNG is a prospective observational clinical study intended to validate Freenome's lung screening test in current and former smokers 50 years and older who are eligible for screening with an LDCT scan, consistent with the updated screening guidelines.

PROACT LUNG objectives include evaluating the sensitivity, specificity, and positive and negative predictive values of Freenome's test in detecting lung cancer among participants during 12- and 24-month follow-up periods. Freenome intends to use data from the study to seek U.S. Food and Drug Administration approval for the test.

The study will enroll as many as 20,000 geographically and demographically representative participants in up to 100 sites across the U.S., with the potential for additional sites globally.

Freenome integrates forward-thinking strategies into its study design and recruitment efforts so that underrepresented populations are included. According to the American Lung Association, Black and Hispanic Americans with lung cancer are 15% less likely than White Americans to be diagnosed early. Among Black and Hispanic Americans with lung cancer, five-year survival rates are 12% and 25% lower, respectively, than White Americans.

Applications of Freenome's multiomics platform include:

• A 2022 study in collaboration with Merck KGaA identified molecular features of disease severity in a subpopulation of non-small lung cell cancer (NSCLC) patients.⁷
  
  
• A 2020 retrospective study in collaboration with Novartis identified prognostic and predictive biomarkers of response to SOC treatment in NSCLC patients.⁸
  
  
• Freenome's over-enrolled Vallania study, a multi-cancer research program that includes approximately 500 patients with lung cancer and more than 1,100 individuals at high risk of lung cancer.
  
  
• In May 2023, Freenome acquired Oncimmune Ltd., the developer of the commercialized autoantibody assay EarlyCDT Lung, to complement Freenome's frontline screening efforts.
  
  
• Freenome is conducting the PREEMPT CRC study, a >35,000-person prospective study for colorectal cancer (CRC) evaluating Freenome's blood-based screening test for CRC in the average-risk population.
  
  
• Freenome partners with Siemens Healthineers on multiomics and radiomic breast cancer diagnostics.

For more information about the Vallania study and PREEMPT CRC, visit Freenome's clinical studies webpage.

About Freenome 

Freenome is a privately held company with a comprehensive multiomics platform for the early detection of cancer using a standard blood draw. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns among billions of circulating cell-free biomarkers. Freenome is headquartered in South San Francisco, California. Find out more at www.freenome.com and visit us on LinkedIn.

¹ Schenk EL, et al. (2021). Oncologist. 26(3): e454-e472.
² Aberle DR, et al. (2011). J Natl Cancer Inst. 103(23):1771-1779.
³ American Lung Association. (2022). State of Lung Cancer 2022. Retrieved from https://www.lung.org/getmedia/647c433b-4cbc-4be6-9312-2fa9a449d489/solc-2022-print-report
⁴ Silvestri GA, et al. (2023). Chest. 2023 Jul;164(1):241-251.
⁵ de Koning HJ, et al. (2020). N Engl J Med. 382(6):503-513.
⁶ Patz EF Jr, et al. (2014). JAMA Intern Med 174(2):269-274.
⁷ Feng Z, et al. Liquid biopsy-based multiomics profiling reveals molecular features of disease severity in EGFR/ALK wildtype NSCLC patients. Presented at AACR 2022.
⁸ Vallania F, et al. Multiomic plasma profiling identifies potential signatures of disease progression in early-stage NSCLC. (2020). Cancer Res. 80(16_Supplement):2433. Presented at AACR 2020.

SOURCE Freenome Holdings, Inc.