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Shield CRC Blood Test Demonstrates Adherence of 95% in New Study of 20,000 Patients

via Business Wire
  • Published study adds to growing evidence that the Shield blood-based screening test boosts adherence

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced new real-world data published in Current Medical Research and Opinion finding that the Shield blood-based screening test demonstrates patient adherence of 95% in screening for colorectal cancer (CRC). Shield is the first and only blood test to receive FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older.

In the analysis looking at the initial implementation of a blood-based CRC screening test, Shield yielded an adherence rate of 95%. In the first 20,000 patients with a Shield clinical order placed between May 2022 and June 2024 patient adherence far surpassed reported adherence rates for colonoscopy or stool-based tests (25-71%). Median test turnaround time was 15 days from blood sample receipt to a results report.

Today’s study is the latest in a growing body of evidence showing that Shield increases patient adherence. An additional study looked at two primary care clinics in Appalachia which ranks low in screening for colorectal cancer with correspondingly some of the highest incident and mortality rates in the U.S.1 In this study, Shield had a clear positive impact increasing overall screening rates for CRC, with positive patient and provider satisfaction, and was the clear preference for screening.

Key findings from the additional study in Appalachia included:

  • An increase in overall rates of screening from 45% to 90% when Shield was added as an option.
  • Shield had an adherence rate of 98.5%.

“We continue to see compounding evidence that when patients are prescribed Shield, they are highly likely to complete the test in real-world clinical practice,” said Dr. Craig Eagle, Guardant Health Chief Medical Officer. “Through a simple blood draw, Shield is proving to be an accessible and pleasant option for physicians and patients.”

Colorectal cancer is the second leading cause of cancer-related deaths in the U.S.2 The disease has a 91 percent five-year survival rate if caught in early stages.3 Yet, one out of three eligible adults in the U.S. -- over 50 million people -- do not complete the recommended screening, in part because they find the available options, colonoscopy and stool tests, unpleasant or inconvenient.4 With Shield, individuals can be screened with a simple blood draw, helping to detect cancer early, when it is more treatable. Shield is covered by Medicare and the Veterans Affairs Community Care Network, and is commercially available across the U.S.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Guardant Health 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 December 31, 2024 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.

1 American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2023.pdf

2 American Cancer Society. Key Statistics for Colorectal Cancer. Accessed online May 8, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html

3 American Society of Clinical Oncology. Colorectal Cancer: Statistics. https://www.cancer.net/cancer-types/colorectal-cancer/statistics#

4 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.

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