Guardant Reveal
Guardant Reveal™: Advanced MRD Detection
Guardant Reveal™ is the pioneering tissue-free test designed for the early detection of minimal residual disease (MRD) in colorectal cancer (CRC), with additional applications for breast and lung cancers. This innovative approach allows for faster predictions of cancer recurrence, offering patients and clinicians critical information to make timely treatment decisions. With its focus on minimizing the need for invasive tissue samples, Guardant Reveal™ represents a significant advancement in cancer monitoring technology.
Key Features of Guardant Reveal™
- Zero Tissue Requirement: Guardant Reveal™ operates without the need for invasive tissue samples.
- Limit of Detection: Achieves a tumor fraction as low as 0.01% to maximize sensitivity.
- Fast Turnaround Time: Results are delivered within 7 days, facilitating timely adjuvant decision-making.
- Accurate Disease Burden Quantification: Utilizes advanced methylation-based technology to precisely quantify the disease burden.
These features make Guardant Reveal™ a groundbreaking solution in minimal residual disease detection for colorectal, breast, and lung cancers.
Impact clinical decisions with tissue-free ctDNA monitoring.
Post-surgery setting
Detect any remaining cancer. MRD detection can identify high-risk patients to help guide clinical decisions in the adjuvant setting. With Guardant Reveal, patients receive up to 3 blood draws starting between 3-13 weeks after curative intent therapy.
Surveillance setting
Predict cancer recurrence. Guardant Reveal can detect disease recurrence and easily complements standard-of-care monitoring modalities..
Published Clinical Insights on Guardant Reveal
- Epigenomic-based MRD testing showed high sensitivity and specificity in predicting recurrence in CRC.
Nakamura et al., Clinical Cancer Research, 2024 - High sensitivity and specificity rates, along with substantial lead time, were shown when predicting recurrence in early-stage breast cancer.
Janni et al., Cancer Research, 2022 - MRD testing through ctDNA monitoring accurately predicted recurrence in early-stage CRC.
Parikh et al., Clinical Cancer Research, 2021Guardant Reveal is covered by Medicare for patients with stage II or III colorectal cancer (CRC) when testing is initiated within three months following curative intent therapy.
Important Information About Guardant Reveal
Guardant360 is a Laboratory Developed Test (LDT) established by Guardant Health Clinical Laboratory in Redwood City, CA, recognized for its high-complexity clinical testing under CLIA certification. Although it has not received FDA approval, the test offers valuable insights by analyzing mutant allele fraction (MAF), microsatellite instability (MSI), and tumor mutation burden (TMB). The features of Guardant360 may vary depending on the specific product configuration. Importantly, over 92% of patients are likely to face no cost for the test, enhancing accessibility.
Disclaimer
To qualify for automatic reflex to comprehensive molecular profiling, a patient must meet the following criteria:
- Have stage II or III colorectal cancer (CRC)
- Have a positive Guardant Reveal MRD test with a tumor fraction at or above 0.05%
- Not have had a Guardant liquid therapy selection test within the last 45 days
Providers can opt out of automatic reflex by selecting the “Opt out of reflex” option on the Guardant Health Test Requisition Form.
Abbreviations:
- CEA: Carcinoembryonic antigen
- CRC: Colorectal cancer
- CT: Computerized tomography
- ctDNA: Circulating tumor DNA
The content covers the use of plasma-only circulating tumor DNA (ctDNA) assays for detecting minimal residual disease (MRD) in cancers like colorectal, breast, and lung. It includes references to studies and guidelines, discussing the advantages, challenges, and clinical relevance of ctDNA testing for monitoring recurrence and therapy effectiveness.