New Guardant Reveal™ data from interim analysis of COSMOS-CRC-01 demonstrates high performance for recurrence detection in early-stage colorectal cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it will present data highlighting the clinical utility of its liquid biopsy tests in the treatment and management of early- to late-stage gastrointestinal cancers, including colorectal cancer, at the 2022 ASCO Gastrointestinal Cancers Symposium being held January 20-22, 2022.

An interim analysis from COSMOS-CRC-01, a large, prospective, observational study, shows that the Guardant Reveal™ liquid biopsy test, when performed after curative intent surgery for stage II-III colorectal cancer, can detect molecular residual disease (MRD) prior to disease recurrence with an average lead time of greater than six months. The test integrates genomic and epigenomic signatures to detect disease without the need for tumor tissue. (Abstract 168)

Additionally, clinical utility data will demonstrate that the Guardant360^® liquid biopsy test detects microsatellite instability-high (MSI-H) status in patients with advanced gastrointestinal cancers at a similar frequency to tissue-based testing^1,2. MSI-H is an important biomarker used to predict response to immunotherapy. Also, real-world clinical outcomes data from the GuardantINFORM™ platform showed that colorectal cancer patients who received immune checkpoint blockade therapy after MSI-H status identification with Guardant360 achieved responses in line with published data in previously treated MSI-H advanced gastrointestinal cancers^1,2. (Abstract 56)

“These studies further demonstrate the significant clinical value that our blood tests offer in detecting and monitoring cancer, which can help physicians make informed treatment decisions in patients with early- or late-stage gastrointestinal cancer without the need for an invasive tissue biopsy,” said Helmy Eltoukhy, Guardant Health co-CEO. “Tissue biopsies can be difficult to obtain, time-consuming, and lead to complications, all of which can delay a patient’s treatment. Our blood-based tests can overcome these barriers and provide fast and actionable information to help guide treatment decisions across the continuum of care.”

Full List of Guardant Health Presentations:

• Impact of postoperative integrated genomic and epigenomic signatures of circulating tumor DNA (ctDNA) on recurrence in resected colorectal cancer: Initial report of a prospective ctDNA monitoring study COSMOS-CRC-01 (Abstract 168)
• Clinical utility of microsatellite instability (MSI-H) identified on liquid biopsy in advanced gastrointestinal cancers (aGI) (Abstract 56)
• Phase II/III study of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) (Abstract TPS233)
• Circulating tumor DNA dynamics on front-line chemotherapy with bevacizumab or cetuximab in metastatic colorectal cancer: A biomarker analysis for acquired genomic alterations in CALGB/SWOG 80405 (Alliance) randomized trial (Abstract 193)
• Minimal residual disease assessment in colorectal cancer (MiRDA-C) (Abstract TPS236)
• Comprehensive landscape of BRAF variant classes, clonalities, and comutations in metastatic colorectal cancer using ctDNA profiling (Abstract 152)
• Evaluation of baseline BRAF V600E mutation in circulating tumor DNA and efficacy response from the BEACON study (Abstract 162)
• The role of serial analysis of hepatocellular carcinoma via circulating tumor DNA in identification of new actionable alterations (Abstract 478)
• Multiomic characterization to reveal a distinct molecular landscape in young-onset pancreatic cancer (Abstract 594)
• Does detection of microsatellite instability-high (MSI-H) by plasma-based testing predict tumor response immunotherapy (IO) in patients with pancreatic cancer? (Abstract 607)

The full abstracts can be found at the official ASCO Gastrointestinal Cancers Symposium website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market-leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 blood test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 260 peer-reviewed publications including over 80 clinical outcomes studies. It has been trusted by more than 11,000 oncologists with more than 250,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.

About Guardant Reveal

Guardant Reveal test the first blood-only test that detects residual and recurrent disease in patients with Stage II and III CRC in under two weeks without the need for a tissue biopsy. The test detects ctDNA in blood after surgery to identify patients with residual disease who may benefit most from adjunctive therapy, and to monitor for recurrence of CRC in previously diagnosed patients.

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, 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. Hause RJ, Pritchard CC, Shendure J, Salipante SJ. Classification and characterization of microsatellite instability across 18 cancer types. Nat Med. 2016;22(11):1342-1350.
2. Bonneville R, Krook MA, Kautto EA, et al. Landscape of microsatellite instability across 39 cancer types. JCO Precis Oncol. Published online October 3, 2017.

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