Guardant Health submits premarket approval application to the U.S. Food and Drug Administration for Shield™ blood test

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield™, Guardant Health’s blood test to screen for colorectal cancer (CRC).

The submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults. Preliminary results from the study showed that the Shield test achieved 83% sensitivity for the detection of colorectal cancer with specificity of 90%.

“Completing our FDA PMA application for Shield is a significant step forward toward our mission of saving millions of life-years through accessible blood-based cancer screening. We are looking forward to partnering with the agency on bringing this life-saving test to the market,” said AmirAli Talasaz, co-CEO of Guardant Health. “Colorectal cancer is the second leading cause of cancer related death, yet one in three eligible adults are not up to date with screening.¹ Patient access to blood-based screening can help overcome barriers to traditional screening modalities, especially in underserved populations.”

The success of a CRC screening program depends on having tests with acceptable performance, but also on the willingness of the target population to complete the screening test.² Since the launch of the lab developed version of the Shield test in May 2022, it has shown approximately 90% adherence in a real-world clinical setting, demonstrating the value of blood-based screening to increase adherence to recommended screening protocols.³ 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.^3,4,5,6

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 U.S. The ECLIPSE study included more than 200 clinical trial sites in rural and urban communities across 34 states. Study data includes 13% Black, 15% Hispanic and 7% Asian American populations. Enrollment among Black Americans was above average for a clinical trial, which is important given the disproportionate impact of CRC on the black community.⁷

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.

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 GuardantOMNI^® tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the 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 February 17, 2023. https://www.cancer.net/cancer-types/colorectal-cancer/statistics.
2. Adler A, Geiger S, Keil A, et al. Improving compliance to colorectal cancer screening using blood and stool based tests in patients refusing screening colonoscopy in Germany. BMC Gastroenterol. 2014;14:183. doi:10.1186/1471-230X-14-183
3. Shield LDT internal data on file. Guardant Health, Inc.
4. 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.
5. 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.
6. lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. NEJM. 2014.
7. U.S. Food & Drug Administration. 2020 Drug Trials Snapshots Summary Report. FDA.gov website. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots. Accessed December 1, 2022.

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