• Suite of AI-powered expert systems and discovery platforms will be developed internally and through outside partnerships
• First application using AI-backed image analysis developed by Lunit® for Guardant360 TissueNext^TM PD-L1 test improves biomarker detection by >20% in NSCLC
• Future planned applications include deep learning-driven genomic, epigenomic and spatial biomarker discovery via collaboration with biopharma partners and integration with GuardantINFORM™ real-world clinical data platform

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today the introduction of Guardant Galaxy^TM, a suite of advanced analytical technologies developed internally and through outside partnerships to enhance the performance and clinical utility of Guardant Health’s portfolio of cancer tests and to power the next generation of biomarker and drug discovery.

“Precision medicine has clearly demonstrated its potential to improve outcomes for patients with cancer, and our genomic profiling tests play a key role by identifying cancer biomarkers and other factors that can inform diagnosis and therapy selection,” said Helmy Eltoukhy, co-CEO of Guardant Health. “With Guardant Galaxy, we are now accessing the most advanced AI analytics and complementary technologies from leading companies in cancer diagnostics. This will enable us to enhance the capabilities of our tests to provide oncologists and researchers with precise and actionable information and accelerate the development of new biomarker and drug discovery technologies.”

The first application in the Guardant Galaxy suite is an AI-backed digital pathology platform developed by Lunit®, a Seoul, South Korea-based company that develops AI solutions for precision diagnostics and therapeutics. The AI-powered scoring algorithm for the enhanced Guardant360 TissueNext PD-L1 test, which is now commercially available,* improved detection of the cancer biomarker by more than 20 percent compared to manual pathologist interpretation in the most challenging non-small cell lung cancer (NSCLC) cases. Findings from a recently published study indicate that the algorithm can assist pathologists by minimizing interpretation discrepancy and allowing for much better prediction of treatment outcomes.¹

“We are excited to partner with Guardant Health in leveraging the power of AI and digital pathology to enhance the capabilities of Guardant’s portfolio for cancer patients,” said Brandon Suh, CEO at Lunit. “The development of the AI-supported scoring algorithm for the Guardant360 TissueNext PD-L1 test is a great example of using advanced medical image analytics to enhance precision diagnostics in lung cancer and help oncologists find the right treatment for the right patients.”

In addition to enhancing current standard-of-care biomarker interpretation, early Guardant Galaxy applications will also include novel native AI analysis applications, including the prediction of patient response to immunotherapy based on the spatial distribution of immune, stromal and tumor cells in standard H&E-stained slides.

Additional planned applications include enhanced oncology drug and biomarker discovery and development capabilities based on mining the extensive genomic and epigenomic data produced by Guardant Health’s diagnostic tests, cross-referenced to real-world outcomes data available through the GuardantINFORM data platform. Guardant Health also plans to expand the Guardant Galaxy technology suite over time to include other technology partnerships that will support additional segments of its cancer diagnostics portfolio.

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 GuardantINFINITY™ for advanced-stage cancer, and Guardant Reveal™ for early-stage cancer. The Guardant Health screening portfolio, including the Shield^TM 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.

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 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.

*The Guardant360 TissueNext PD-L1 test with enhanced biomarker detection from Guardant Galaxy is not available as a standalone test; it is automatically included when physicians order the Guardant360 CDx test with the Guardant360 TissueNext and PD-L1 test for NSCLC.

References

1. Choi S. et al. Artificial intelligence–powered programmed death ligand 1 analyser reduces interobserver variation in tumour proportion score for non–small cell lung cancer with better prediction of immunotherapy response. Eur J Cancer 2022;170:17-26.

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