- Multi-Cancer Assay Highly Sensitive and Specific in Screening for Detection of Early-Stage Cancers, Able to Identify Tumor Tissue of Origin with High Accuracy

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced new data demonstrating the ability of the company’s investigational next-generation Guardant SHIELD™ multi-cancer assay to accurately detect early-stage cancers. This assay is designed to analyze approximately 20,000 epigenomic biomarkers that are informative for detection of a wide range of solid tumors in a single blood test. The data for four cancer types were demonstrated as examples: colorectal, lung, pancreatic and bladder. These cancers alone account for more than 200,000 cancer-related deaths in the U.S. annually.¹ In addition, the blood test identified the tumor tissue of origin with high accuracy. These data were presented during an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting.

Data from the presentation show that the next-generation Guardant SHIELD multi-cancer screening assay achieved sensitivity (detection rates) of 90% (n=692) in stages I and II colorectal cancer (CRC) and 87% (n=55) in stages I and II lung cancer. For more advanced cancer (stages III and IV), sensitivity was 93% (n=582) for CRC and 93% (n=136) for lung cancer. Detection was assessed at 90% specificity (true negative rates) based on a cohort of patients without cancer. This performance is on par with current guideline-recommended screening methods. Current screening options for these cancers, while effective, are limited due to low compliance rates: 66% for CRC and 14% for lung cancer.^2,3 A high-performance blood test that can be completed as part of a routine patient workup has the potential to improve screening rates and, ultimately, save more lives.

In addition, the multi-cancer screening assay achieved sensitivity of 73% (n=11) in stages I and II pancreatic cancer and 52% (n=23) in stages I and II bladder cancer. For more advanced cancer (stages III and IV), sensitivity was 84% (n=31) in pancreatic cancer and 85% (n=61) in bladder cancer. Since there is no screening paradigm or diagnostic pathway for these cancers, a specificity threshold of 95% was targeted to reduce false positive rates while ensuring sensitivity is clinically impactful.

Highly accurate tumor tissue of origin prediction is needed when more than one cancer type is evaluated as part of a single assay to help direct patients to the most effective follow up for a positive test. The tumor tissue of origin prediction was evaluated at 98% specificity and correctly identified the tumor tissue of origin in 99% of colorectal, 94% of lung, 88% of bladder, and 86% of pancreatic cancers.

“These positive results show that the next-generation Guardant SHIELD multi-cancer assay provides sensitive detection of early-stage cancers with the ability to identify the tumor tissue of origin with high accuracy,” said AmirAli Talasaz, Guardant Health co-CEO. “Presentation of these positive results represents a major step forward in our commitment to offering clinicians and patients a highly sensitive blood-based multi-cancer screening test in select tumor types where we believe cancer screening can save lives.”

The investigational next-generation Guardant SHIELD multi-cancer test aims to detect early-stage cancer where there is a clinical benefit from early detection and treatment. In January 2022, Guardant Health initiated the SHIELD Lung study, a prospective, observational, multi-center basket study designed to enroll individuals undergoing cancer screening across multiple cancer types. The first cohort, or basket, will enroll nearly 10,000 individuals eligible for lung cancer screening and aims to evaluate the performance of the next-generation Guardant SHIELD test to detect lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe. Additional information about the study is available at clinicaltrials.gov (NCT05117840).

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 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, 2021, and any current and periodic reports filed with the Securities and Exchange Commission thereafter. 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 Cancer Society. Understanding Cancer Death Rates. Available at https://www.cancer.org/latest-news/understanding-cancer-death-rates.html. Accessed online April 4, 2022.

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 April 4, 2022.

3. Zahnd WE, Eberth JM. Lung cancer screening utilization: a behavioral risk factor surveillance system analysis. Am J Prev Med. 2019;57(2):250-255. doi:10.1016/j.amepre.2019.03.015

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