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*The U.S. Food and Drug Administration (FDA) grants oversight of Lab Developed Tests (LDTs) to the Centers for Medicare & Medicaid Services (CMS). LDTs are regulated by CMS under the Clinical Laboratory Improvement Amendment (CLIA), which subjects LDTs to strict personnel, quality control, and proficiency testing standards.8
1. Data on file. Guardant Health, Inc. 2. Evaluation of the ctDNA LUNAR test in an average patient screening episode (ECLIPSE). ClinicalTrials.gov identifier: NCT04136002. https://clinicaltrials.gov/ct2/show/NCT04136002?term=NCT04136002&draw=2&rank=1
3. American Society of Clinical Oncology. Colorectal cancer: statistics. https://www.cancer.net/cancer-types/colorectal-cancer/statistics 4. Guardant Health initiates ORACLE study to evaluate performance of Guardant Reveal™ Blood Test to predict recurrence across
early-stage cancers. https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Initiates-ORACLE-Study-to-Evaluate-Performance-of-Guardant-Reveal-Blood-Test-to-Predict-Recurrence-Across-Early-Stage-Cancers/default.aspx
5. Guardant Health expands Guardant360® portfolio with new tests for treatment response monitoring and complete genomic profiling. https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant-Health-Expands-Guardant360-Portfolio-
With-New-Tests-for-Treatment-Response-Monitoring-and-Complete-Genomic-Profiling/default.aspx 6. Guardant Health receives expanded Medicare coverage for Guardant360 across the vast majority of solid tumor cancers. https://investors.guardanthealth.com/
press-releases/press-releases/2019/Guardant-Health-Receives-Expanded-Medicare-Coverage-for-Guardant360-Across-the-Vast-Majority-of-Solid-Tumor-Cancers/default.aspx 7. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test 8. D’Angelo, R., Weiss, R., Wolfe, D., Chinnam, R., Murat, A., Gluesing, J., & Somers, T. (2018). Being Prepared for Regulatory Requirements for Laboratory Developed Tests. American Journal of Clinical Pathology, 149(6), 484–498. https://doi.org/10.1093/AJCP/AQY014