Guardant Health was on prominent display at the recent Precision Medicine World Conference (PMWC 2024) (January 24-26) in Silicon Valley. The company’s co-founders and co-CEOs, Helmy Eltoukhy, PhD, and AmirAli Talasaz, PhD, were each presented with a PMWC Luminary Award for their work transforming the precision oncology field through the development of the advanced non-invasive liquid biopsy. Both received their PhDs in electrical engineering from Stanford and believe this training allows them to bring an engineering “problem-solving” approach to biology. At the PMWC, Dr. Eltoukhy moderated a panel discussion on “Status Quo of Clinical Liquid Biopsy” and Dr. Talasaz participated in a panel discussion on “Liquid Biopsy for Health Monitoring and Disease Prevention.” Guardant Health, a global organization headquartered in Palo Alto, California, is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data, and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer.
Guardant Health is proud to partner with over 150 biopharma companies to support their efforts in bringing the next generation of cancer therapeutics to patients sooner. The company leaders believe that collaboration is a key way to speed progress. Its scientists are pioneering multi-omic approaches to power precision oncology with deeper insights. The company’s portfolio of innovative solutions and best-in-class services span translational research, clinical development and commercialization, and real-world evidence.
Residual Disease Detection and Recurrence Monitoring
The Guardant Reveal™ test is a revolutionary blood-only liquid biopsy test that detects circulating tumor DNA (ctDNA) for minimal residual disease (MRD) assessment in early-stage colorectal (CRC), breast, and lung cancers. Guardant Reveal is covered for fee-for-service Medicare patients with Stage II or III colorectal cancer (CRC) whose testing is initiated within three months following curative intent therapy. 1-4
Guardant360® Tests for Treatment Selection in Late-Stage Cancers
For doctors treating patients with advanced cancer, the Guardant360® portfolio of tests provides a complete genomic view at every step of the treatment journey, delivering insights to quickly match patients to the right targeted treatment based on their genomic profile, and also monitor response to that treatment.
The Guardant360® CDx test is the first FDA-approved blood test for complete genomic testing. The test is FDA-approved for complete genomic testing across all solid cancers, providing doctors guideline-complete genomic results in 7 days from a simple blood draw to inform treatment decisions. A blood test does not require tissue testing, enabling more patients to benefit from the growing number of FDA-approved targeted therapies. Starting with the Guardant360 CDx test for complete genomic profiling identifies more patients with actionable biomarkers more quickly than starting with tissue biopsy.5-7 The test covers all genes recommended by the National Comprehensive Cancer Network, including the 55 most relevant to clinical care. The test is approved as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who may benefit from treatment with TAGRISSO® (osimertinib), RYBREVANT® (amivantamab-vmjw), ENHERTU® (fam-trastuzumab deruxtecan-nxki) or LUMAKRAS™ (sotorasib). It is also FDA approved to identify advanced breast cancer patients with ESR1 mutations who may benefit from treatment with ORSERDU™ (elacestrant).
If you are a healthcare provider in the United States looking for more information about Guardant360 CDx, please visit this product website. If you are located in Europe & Latin America, please visit this website. If you are in Canada, please visit thiswebsite. If you are a healthcare provider in Asia, the Middle East, or Africa, please visit this website.
The Guardant360 TissueNext™ testis used to find actionable information when tissue testing is appropriate. The test is designed to find additional treatment options for patients who have progressed on therapy. The test covers clinically relevant biomarkers, including tumor mutational burden (TMB), microsatellite instability (MSI), homologous recombination repair (HRR) genes and selected fusions.
,Guardant360 Response Test for Monitoring and Minimal Residual Disease (MRD) Assessment
The Guardant360 Response™ test is designed to measure changes in circulating tumor DNA (ctDNA) in late-stage solid cancers in order to assess early response to treatment. The Guardant360 Response™ test is the first blood-only test that enables doctors to view molecular response, or changes in ctDNA levels, from a simple blood draw to get an early indication of patient response to immunotherapy or targeted therapy. For doctors, knowing early and confidently if a patient’s treatment is working is critical in deciding whether to continue, stop, or explore other options. Studies show the Guardant360 Response test can predict treatment response 8 weeks earlier than current standard-of-care imaging.
Guardant Shield™ Test
Guardant’s Shield™ test is the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC. Today, 1 in 3 adults are not completing the recommended colorectal cancer screening. A blood test can improve these rates by overcoming barriers associated with available methods, including colonoscopy and stool-based testing, which while effective, can be unpleasant, time-consuming and difficult to complete. This Guardant test has been demonstrated to be accurate at detecting colorectal cancer by identifying ctDNA in the blood. Guardant’s ECLIPSE study validates Shield as a high-sensitivity blood test for colorectal cancer screening and will support premarket approval submission for U.S. FDA approval. Learn more about Guardant’s study results.
GuardantInform™ Platform
GuardantInform™ is Guardant’s real-world evidence database of 263,000+ clinical genomic samples providing insight into therapy use, tumor evolution, and treatment resistance. The platform features 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. 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, clinical trial optimization, and post-marketing studies.
Guardant Infinity™ Platform
The Guardant Infinity platform ushers in a new era of precision oncology providing epigenomic insights from Guardant’s cutting-edge proprietary methylation technology. It allows users to access novel insights to advance multiple precision oncology applications. Guardant Infinity is the first and only platform to combine genomic and epigenomic profiling via liquid biopsy to offer a truly multidimensional view of cancer, now commercially available through our products.
Quantify Cancer with Blood-Based Monitoring. Methylation-based tumor quantification enables the monitoring of cancer across the continuum of cancer care. Methylation-based tumor fraction (TF) can enable identification of tumor signal in up to 50% more cancer patients compared to genomic-only detection.
Blood-Based Therapy Selection. Unrivaled discovery power that combines genomic and epigenomic profiling for multidimensional insights using liquid biopsy. (753 genes, tumor mutational burden (TMB), microsatellite instability (MSI), 15 MB methylation panel).
Tissue-Based Therapy Selection. A multi-omic assay that combines insights across genomics, epigenomics, and RNA (coming soon in 2024).
More on Guardant Health
Guardant Health has the #1 liquid biopsy market share in the United States, with utilization across over 12,000 oncologists.
In a brief interview with BioQuick News, Dr. Talasaz noted that Guardant has now conducted over 500,000 tests since its inception.
Further, he noted that Guardant has a “home brew” method that improves upon the difficult bisulfite detection of methylation.
References
- Backgrounder: Guardant Reveal™ Liquid Biopsy Test. Guardant Health, Inc. Redwood City, CA.
- Parikh AR, Van Seventer EE, Siravegna G, et al. Minimal residual disease detection using a plasma-only circulating tumor DNA assay in patients with colorectal cancer. Clin Cancer Res. 2021;27(20):5586-5594. doi:10.1158/1078-0432.CCR-21-0410
- Janni W, Huober J, Braun T, et al. Multiomic, plasma-only circulating tumor DNA (ctDNA) assay identifies breast cancer patients with minimal residual disease (MRD) and predicts distant recurrence. Poster presented at: American Association for Cancer Research Annual Meeting; April 8-13, 2022; Philadelphia, PA. Accessed June 29, 2023. https://doi.org/10.1158/1538-7445.AM2022-3403
- Nagasaka M, Uddin MH, Al-Hallak MN, et al. Liquid biopsy for therapy monitoring in early-stage non-small cell lung cancer. Mol Cancer. 2021;20(1):82. doi:10.1186/s12943-021-01371-1 5
- Guardant360® CDx Technical Information. Guardant Health, Inc. Redwood City, CA. July 2021.
- FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed June 29, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test
- Foundation Medicine. FoundationOne®Liquid CDx. Accessed June 29, 2023. https://www.foundationmedicine.com/test/foundationone-liquid-cdx
by Michael D. O’Neill, Editor & Publisher, BioQuick News