The Ohio State University-led study will evaluate changes in CRC screening adherence in underserved urban and rural communities

Guardant Health is providing Shield™ blood test to eligible individuals through mobile health clinic partners

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, has announced support for an investigator initiated study led and conducted by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) to evaluate patient compliance with a blood-based test for colorectal cancer (CRC) screening. In this study, The Ohio State University Guardant Shield Colorectal Cancer Screening Project, individuals from minority and underserved populations aged 45 and older who are in need of CRC screening will have the option to receive the Shield blood test, administered by a mobile phlebotomist, as part of their engagement with a community health van. Integrating Shield into mobile health services will allow health care providers to bring blood-based screening directly to communities making it accessible for eligible individuals who are not compliant with CRC screening.

Colorectal cancer is the second leading cause of cancer related death in the United States.¹ Although CRC screening has been shown to improve survival rates, one in three adults have not completed the recommended CRC screening.^2,3 The Appalachian region’s cancer mortality rate is 10% higher than the national average, and the region has higher than average incidence and mortality rates for colorectal cancer specifically.^4,5 Over 40% of the Appalachian population is rural, compared with 20% of the national population, and residents are more likely to have lower incomes, lower levels of education, higher poverty and unemployment rates, and poorer health than their non-Appalachian counterparts.⁶

With a simple blood draw, the Shield test can assist in removing barriers associated with established CRC screening methods because it requires no special preparation, no sedation, no dietary changes, and no extra time away from family or work, and it can be completed as part of any patient office visit.⁷ Shield test performance was recently clinically validated by the ECLIPSE Study – one of the largest cancer screening studies of its kind – and achieved 83% sensitivity for the detection of CRC. Since the launch of Shield, it has shown approximately 90% adherence demonstrating the value of blood-based screening in a real-world clinical setting.⁸

“We learned early on in the COVID-19 pandemic that we need to be innovative in how we deliver care to our communities. By deploying a mobile phlebotomist as part of a mobile health clinic, we are further able to understand the potential and ease of a blood test to reach rural and underserved communities,” said AmirAli Talasaz, Guardant Health co-CEO. “The Ohio State University Comprehensive Cancer Center research team has a long legacy of community leadership in Ohio and Appalachia, so we know we are meeting patients where they are, helping to further reduce barriers to access, and improve CRC screening rates to pre-pandemic levels.”

About The Ohio State University Guardant Shield Colorectal Cancer Screening Project (NCT05716477)

This study will enroll individuals aged 45 years and older from minority and underserved populations who are in need of colorectal cancer screening via mobile health clinics. Approximately 300 patients will be enrolled during the study period. Researchers will evaluate attitudes and beliefs about colorectal cancer screening as part of the study, which is funded by Guardant Health, the manufacturer of the Shield test.

About the Shield™ Test

The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). Specifically, the test identifies specific characteristics of the DNA that may indicate the presence of cancer.

The clinical performance of the Shield assay was validated using an analyzed set of over ten thousand patient samples in a screening study. The test demonstrated 83% sensitivity in detecting individuals with CRC. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. This test also demonstrated 13% sensitivity in detecting advanced adenomas.

Since the launch of the laboratory developed version of the Shield test in May 2022, it has shown approximately 90% adherence in the real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.⁸ In fact, the effective sensitivity of the test, which measures the true impact of a screening test by evaluating adherence and test performance, shows that Shield has the potential to detect more CRCs than traditional modalities.^8,9,10,11

Shield 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 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 GuardantINFINITY™ tests for advanced-stage cancer, and Guardant Reveal™ for early-stage cancer. The Guardant Health screening portfolio, including the commercially launched Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

Guardant Health Forward-Looking Statement

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, 2022 and in its other reports filed with or furnished to 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.

References

1. American Society of Clinical Oncology. Colorectal cancer: statistics. Cancer.net website. Updated February 2022. Accessed March 17, 2023. https://www.cancer.net/cancer-types/colorectal-cancer/statistics.
2. 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
3. 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
4. Association of Community Cancer Centers. Creating a Culture of Health in Appalachia. https://www.arc.gov/wp-content/uploads/2021/02/Health_Disparities_in_Appalachia_Mortality_Domain.pdf. Accessed online March 17, 2023.
5. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf. Accessed online March 17, 2023.
6. Appalachian Regional Commission. The Appalachian Region: A Data Overview From The 2016-2020 American Community Survey. https://www.arc.gov/wp-content/uploads/2022/08/PRB_ARC_Chartbook_ACS_2016-2020_FINAL_2022-09.pdf. Accessed online March 17, 2023.
7. Rich T, Raymond V, Lang K. Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: a systematic review. Gastroenterology. 2020;158(6 suppl 1):S-918. doi:10.1016/S0016-5085(20)32981-4.
8. Shield LDT internal data.
9. 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.
10. Knudsen AB, Rutter CM, Peterse EFP, et al. Colorectal cancer screening: An updated decision analysis for the U.S. Preventive Services Task Force. Rockville (MD): Agency for Healthcare Research and Quality; 2021a. Report No.: 202s.
11. lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. NEJM. 2014.

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