This study indicates Guardant Health’s blood test could provide meaningful clinical performance in an average risk screening population

Guardant Health, Inc. (Nasdaq: GH), presents data at the American College of Gastroenterology Annual Scientific Meeting being held from October 22-27, showing its LUNAR-2 blood test, which has been developed to screen average-risk patients for colorectal cancer (CRC), offers optimized sensitivity and specificity in identifying those with early-stage CRC. This study was selected by the ACG Abstract Selection Committee as the recipient of the International Award.

In the study, researchers evaluated the LUNAR-2 test in a cohort of 699 patients with early-stage (Stage 1, 2, or 3) CRC and found the test achieved an overall sensitivity of 96% in detecting CRC and 94% specificity. These findings are on par with other currently available modalities, such as stool-based screening.¹ The limitation of this retrospective study is that the biobanked samples are from individuals with known CRC and 37% of cases had asymptomatic disease.

“We know that the earlier CRC is detected, the better a person’s chances are of surviving it,” said Dr. Hee Cheol Kim, study investigator and Professor of Surgery at Samsung Medical Center in Seoul, South Korea. “The clinically meaningful sensitivity and specificity of the LUNAR-2 blood test in detecting CRC, most notably in people with early-stage disease, indicates that it could be a very useful tool in improving patient outcomes.”

A further analysis showed that in patients with Stage 1 and 2 CRC, whereby blood-based detection can be especially challenging, the test offered 93% overall sensitivity. Additionally, the blood-based test identified 90% of patients with asymptomatic Stage 1 or 2 CRC, suggesting the test may have meaningful performance in an average-risk screening population. These findings need to get further validated in a registrational screening trial.

“CRC screening saves lives, but we know that only about two-thirds of individuals get screened for CRC² because current options, like a colonoscopy, are invasive and the preparation can be challenging, and other modalities, like stool based testing, have their own challenges to screening adherence,” said AmirAli Talasaz, Guardant Health Co-CEO. “During the COVID-19 pandemic, screening rates have dropped, wellness visits have declined, and postponements of non-emergency medical procedures have made it harder for people to complete life-saving CRC screening. The study results show that the LUNAR-2 test could provide both patients and physicians with an easy-to-use and highly accurate CRC screening alternative in the form of a blood test.”

The LUNAR-2 blood test aims to detect early-stage cancer in screen-eligible asymptomatic adults from a simple blood draw. The ECLIPSE trial (NCT04136002), a registrational study with more than 10,000-patients, is currently underway to evaluate the performance of the LUNAR-2 blood test to detect early-stage colorectal cancer. One of the largest cancer screening studies of its kind, ECLIPSE is expected to complete enrollment in 2021 and, if successful, data will support a pre-market approval (PMA) submission to the United States Food and Drug Administration (FDA).

Data Presented at ACG:

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.

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, 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.

References

1. Ebner DW, Kisiel JB. Stool-Based Tests for Colorectal Cancer Screening: Performance Benchmarks Lead to High Expected Efficacy. Curr Gastroenterol Rep. 2020;22(7):32. Published 2020 Jun 3. doi:10.1007/s11894-020-00770-6.
2. American Cancer Society: Colorectal Cancer Facts & Figures 2020-2022. Available at: 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 October 19, 2021.
3. Guardant Health, Inc. October 2019. Evaluation of the ctDNA LUNAR Test in an Average Patient Screening Episode (ECLIPSE). Identifier NCT04136002. https://clinicaltrials.gov/ct2/show/NCT04136002

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