Topline Data Release from ECLIPSE Planned for Mid-2022
Subject to Positive Study Outcome, Data Will Support a Premarket Approval (PMA) Submission to the U.S. FDA in 2022
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that it has reached its target enrollment of 12,750 patients in ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Encounter), a registrational study to evaluate the performance of its LUNAR™-2 blood test to detect colorectal cancer (CRC) in average-risk adults. Subject to positive study results, the number of patients currently enrolled in ECLIPSE is targeted to support a premarket approval (PMA) submission to the U.S. Food and Drug Administration in 2022.
“Colorectal cancer screening rates have remained stubbornly low due to the nature of current screening methods. New modalities in colorectal cancer screening, such as a routine, accurate blood test like the one being studied in the ECLIPSE study, has the potential to increase screening rates dramatically,” said AmirAli Talasaz, Guardant Health co-CEO. “Reaching this significant enrollment milestone highlights our ability to successfully run one of the largest cancer screening studies of its kind and gives us tremendous confidence in initiating large registrational studies in other cancer types, including the SHIELD screening study to detect lung cancer. It is also a testament not just to our team’s perseverance, but also to the commitment of our clinical researchers and the generosity of those enrolled in the study.”
Today, it is estimated that 1 in 3 adults in the U.S. does not adhere to national CRC screening recommendations even though regular screening for colorectal cancer has been shown to improve survival rates.1,2 Increasing screening rates to 80% from current levels could reduce the number of people diagnosed with CRC by 22% by 2030.3 However, current screening methods are time consuming and, in the case of a colonoscopy, invasive. LUNAR-2 is intended to improve CRC screening rates by offering a simple blood test that overcomes barriers associated with current testing methods and facilitates access to screening tests to more individuals and communities where access may be limited.
“Given the importance of this study and the size of the cohort, we’re grateful Guardant Health has been able to enroll 12,750 study participants in just over two years during a global pandemic,” said William M. Grady, M.D., Professor, Clinical Research Division, Fred Hutchinson Cancer Research Center. “We look forward to evaluating the data from the ECLIPSE study to increase our understanding of blood-based screening in patients at average risk for colorectal cancer.”
ECLIPSE is a prospective, multi-site registrational study to evaluate the performance of the company’s LUNAR-2 blood test to detect colorectal cancer in individuals aged 45-84 in the U.S. who are at average risk for colorectal cancer, including those who have historically been underrepresented in clinical research and identify as Native American and Black or African American. More details about ECLIPSE can be found at NCT04136002.
About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2020 and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.
- Joseph DA, King JB, Richards TB, et al. Use of Colorectal Cancer Screening Tests by State. Prev Chronic Dis 2018;15:170535. DOI:https://www.cdc.gov/pcd/issues/2018/17_0535.htm
- Brenner H, Jansen L, Ulrich A, et al. Survival of patients with symptom- and screening-detected colorectal cancer. Oncotarget. 2016;7(28):44695–44704. doi:10.18632/oncotarget.9412
- Meester RG, Doubeni CA, Zauber AG, et al. Public health impact of achieving 80% colorectal cancer screening rates in the United States by 2018. Cancer. 2015;121(13):2281-2285.