Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine
- Study shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90%
- Results pave the way for first potential FDA-approved blood test for colorectal cancer screening to meet requirements for Medicare coverage
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Shield (TM) from
“Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz,
One of the largest studies of its kind, ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode) is a 20,000+-patient registrational study to evaluate the performance of Shield compared to a screening colonoscopy. The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA).
Highlights of the study results to be published in
- 83% sensitivity in detecting individuals with CRC
- 88% sensitivity in detecting pathology-confirmed Stages I-III
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Sensitivity by stage of:
- 65% for pathology-confirmed Stage I; 55% for clinical Stage I
- 100% for Stage II
- 100% for Stage III
- 100% for Stage IV
These results are on par with the performance of other guideline-recommended non-invasive screening modalities, where overall sensitivity in detecting colorectal cancer ranges from 74% to 92%.1
“More than 3 out of 4 Americans who die from colorectal cancer are not up to date with their recommended screening,2 highlighting the need for a more convenient and less invasive screening method that can overcome barriers associated with traditional options,” said
Publication of ECLIPSE follows Guardant Health’s submission of its premarket approval (PMA) application to the
“Colorectal cancer is highly treatable if caught in the early stages, yet more than 50 million people in the
Colorectal cancer is the second-leading cause of cancer deaths in the
“The results of the study are a promising step toward developing more convenient tools to detect colorectal cancer early while it is more easily treated,” said corresponding author
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About the ECLIPSE study
ECLIPSE is a prospective registrational study to evaluate the performance of Guardant Health’s blood test in detecting signs of CRC compared to a screening colonoscopy in average-risk adults between the ages of 45 and 84 from across the
About Shield
The Shield test for colorectal cancer screening is commercially available for eligible individuals by prescription only through healthcare professionals. This LDT (Laboratory Developed Test) is intended to be complementary to, and not a replacement for, current recommended CRC screening methods. A negative result does not rule out the presence of cancer. Patients with an abnormal blood-based screening result should be referred for a diagnostic colonoscopic evaluation.
More information about the Shield test is available at bloodbasedscreening.com.
About
Forward-Looking Statements
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
Disclosures
References
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Chung, D., et al. Clinical Validation of a Cell-Free DNA Blood-Based Test for Colorectal Cancer in an Average Risk Population. Abstract #3910067. Digestive Disease Week 2023;
May 6-9, 2023 ;Chicago, IL. -
Gastroenterology. 2019 Jan; 156(1): 63–74.e6. www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&retmode=ref&cmd=prlinks&id=30268788. Accessed
March 6, 2024 . -
Bretthauer M, Løberg M, Wieszczy P, et al.;
NordICC Study Group . Effect of colonoscopy screening on risks of colorectal cancer and related death. N Engl J Med. 2022;387:1547-1556. -
Knudsen AB , Rutter CM, Peterse EFP, et al. Colorectal cancer screening: An updated decision analysis for theU.S. Preventive Services Task Force .Rockville (MD):Agency for Healthcare Research and Quality ; 2021a. Report No.: 202s. - Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Eng J Med. 2014.
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Coronado GD, Jenkins CL, Shuster E, et al. Blood-based colorectal cancer screening in an integrated health system: a randomised trial of patient adherence. Gut. Epub ahead of print:
23 January 2024 . doi:10.1136/gutjnl-2023-330980. -
American Cancer Society : Colorectal Cancer Key Statistics. www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html Accessed onlineFeb 5, 2021 . -
Colorectal Cancer Alliance . https://colorectalcancer.org/resources-support/community-support/young-onset-support/young-onset-crc-facts. AccessedMarch 13, 2024 . -
Doubeni CA,
Fedewa SA , Levin TR, et al. Modifiable Failures in the Colorectal Cancer Screening Process and Their Association With Risk of Death. Gastroenterology 2019;156:63–74. -
U.S. Food & Drug Administration . 2022 Drug Trials Snapshots Summary Report. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots. AccessedDecember 18, 2023 .
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