Guardant Health Launches Real-World Clinical-Genomic Platform to Accelerate Precision Oncology Drug Development

REDWOOD CITY, Calif., June 23, 2020 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, addresses the challenges of developing new precision oncology medicines by unveiling the GuardantINFORM^™  platform featuring an extensive clinical-genomic liquid biopsy dataset of advanced cancer patients.

The GuardantINFORM 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 —over 100,000 tests to date. 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. The most notable applications for the GuardantINFORM platform include:

• Targeted drug development: Identify, characterize, and prioritize cohorts of patients with biomarker-defined cancers and in need of treatment options for potential new drug development indications and label expansions.
   
• Clinical trial optimization: Incorporate real-world clinical-genomic data into clinical trial design, control arm simulation, clinical operations activities, and clinical development decision-making.
   
• Post-marketing studies: Conduct health outcomes and safety studies of on- and off-label use of marketed therapies using real-world market insights and estimates of progression-free and overall survival in biomarker-defined cancers.

“The GuardantINFORM platform represents an important milestone in our mission to conquer cancer with data, with liquid biopsy samples from more than 100,000 patients accumulated over the past five years,” said Helmy Eltoukhy, Guardant Health co-founder and CEO. “The richness of this clinical-genomic platform, combined with the complexity and diversity of all metastatic solid tumors, offers researchers more immediate access to real-world drug resistance and tumor evolution information which we believe will accelerate their development of novel therapeutics and new indications for patients.”

Recent data presented at the AACR Virtual Annual Meeting II quantify¹ the robustness of the GuardantINFORM real-world clinical-genomic platform, and its potential to support drug development using circulating tumor DNA (ctDNA) as a valuable alternative to serial tissue testing. In a cohort of patients who underwent Guardant360 serial ctDNA testing, test results were linked to de-identified medical and pharmacy claims; a robust longitudinal view of the diagnoses, treatments, and clinical outcomes was accessible for the majority of patients.¹ The availability of clinical-genomic information following systemic therapy confirms that this platform can serve as a valuable resource for precision oncology drug development researchers to evaluate drug resistance and tumor evolution in patients with advanced cancer in a real-world setting.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood 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 launched liquid biopsy-based Guardant360 and GuardantOMNI tests for advanced stage cancer patients. These tests fuel development of its LUNAR program, which aims to address the needs of early stage cancer patients with neoadjuvant and adjuvant treatment selection, cancer survivors with surveillance, asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential applications, benefits and advantages of Guardant Health’s GuardantINFORM platform as well as its clinical-genomic dataset, 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. Such risks and uncertainties include those discussed under the caption “Risk Factors” in Guardant Health’s Annual Report on Form 10-K for the year ended December 31, 2019, its Quarterly Report on Form 10-Q for the period ended March 31, 2020, and in its other reports filed with the Securities and Exchange Commission. These forward-looking statements are based on current expectations, forecasts, assumptions and information available to Guardant Health as of the date hereof, and actual outcomes and results could differ materially from these statements due to a number of factors, 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. Investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Guardant Health.

Investor Contact:
Carrie Mendivil
[email protected]

Media Contact:
Anna Czene
[email protected]

Becky Lauer
[email protected]

References

1. Kumar N, Hanna D, Yu J, et al. Development of a clinical-genomic database to study tumor evolution and molecular biomarkers of drug resistance in a real-world setting. Poster presented at: AACR Virtual Meeting II: June 22, 2020.