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Guardant Health: Data Presented at ACG Shows Guardant Health’s Blood Test Accurately Detects Early-Stage Colorectal Cancer

This study indicates that Guardant Health’s blood test could provide significant clinical performance in a medium-risk screening population

Guardant Health, Inc. (Nasdaq: GH), presents data at the American College of Gastroenterology Annual Scientific Meeting October 22-27, showing its LUNAR-2 blood test, which was developed to screen patients at medium risk for colorectal cancer. cancer (CRC), offers enhanced sensitivity and specificity in identifying individuals 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 CRC (stage 1, 2 or 3) and found that the test achieved an overall sensitivity of 96% in the detection of CCR and specificity of 94%. These results are comparable to other modalities currently available, such as stool-based screening.1 The limitation of this retrospective study is that the biobank 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 chance of survival,” said Dr. Hee Cheol Kim, researcher and professor of surgery at Samsung Medical Center in Seoul, South Korea. “The clinically significant sensitivity and specificity of the LUNAR-2 blood test in detecting CRC, especially in people with early stage disease, indicates that it could be a very useful tool to improve patient outcomes. . ”

Further analysis showed that in patients with stage 1 and 2 RCC, for whom blood-based detection can be particularly difficult, the test offered an overall sensitivity of 93%. Additionally, the blood test identified 90% of patients with asymptomatic stage 1 or 2 RCC, suggesting that the test may have significant performance in a medium risk screening population. These results need to be further validated as part of a registry screening trial.

“Screening for CRC saves lives, but we know that only about two-thirds of people get screened for CRC2 because current options, like colonoscopy, are invasive and preparation can be difficult, and other modalities, like stool-based testing, have their own challenges for screening adherence, ”said AmirAli Talasaz, co – CEO of Guardant Health. “During the COVID-19 pandemic, testing rates fell, wellness visits declined, and postponements of elective medical procedures made it more difficult for people to complete the life-saving CRC screening. The results of the study show that the LUNAR-2 test could provide 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 cancer at an early stage in asymptomatic adults eligible for screening from a simple blood test. The ECLIPSE test (NCT04136002), a registration study with more than 10,000 patients, is currently underway to assess the performance of the LUNAR-2 blood test for detecting early-stage colorectal cancer. One of the largest cancer screening studies of its kind, ECLIPSE is expected to complete recruitment in 2021 and, if successful, the data will support a pre-market approval (PMA) submission to the Food and Drug Administration (FDA) of the United States.

Data presented to the ACG:

Title

Oral summary no.

Presenter

Multimodal circulating tumor DNA (ctDNA) blood-based colorectal cancer (CRC) screening test demonstrates clinically significant sensitivity in several clinical settings

24

Dr Hee Cheol Kim

About Guardant Health

Guardant Health is a leading precision oncology company focused on fighting cancer globally through the use of its proprietary tests, large datasets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient outcomes, and reduce 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 patients with advanced cancer, and Guardant Reveal ™ for patients with advanced cancer. early stage. These tests are fueling the development of its LUNAR screening program, which aims to meet the needs of asymptomatic people 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 uses, values, benefits, and benefits of Guardant Health’s liquid biopsy tests or tests, which involve risks and uncertainties that could cause actual results to differ. materially anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual results could differ materially from these statements due to a number of factors. These 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 forward-looking statements made in this press release include those discussed under the sections “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” 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 contained 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 upon which such a statement is based, except as required by law. These forward-looking statements should not be taken as representing the views of Guardant Health as of any date subsequent to the date of this press release.

The references

  1. Ebner DW, Kisiel JB. Stool-based tests for colorectal cancer screening: performance criteria lead to high expected efficacy. Curr Gastroenterol Rep. 2020; 22 (7): 32. Posted June 3, 2020. doi: 10.1007 / s11894-020-00770-6.

  2. American Cancer Society: Colorectal Cancer Facts and 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 Assay in an Average Patient Screening Episode (ECLIPSE). Identifier NCT04136002. https://clinicaltrials.gov/ct2/show/NCT04136002