Maximize residual detection for minimal residual disease (MRD).1
Maximize sensitivity by interrogating thousands
of epigenomic and genomic signals with the
first tissue-free MRD test for colorectal cancer (CRC),
now available for breast and lung cancers.1-4
Precisely quantify tumor fraction with a limit of detection as low as 0.01%.5
Simple blood draw that provides MRD detection without tissue dependency.1
Supplement to standard of care (SOC) monitoring that may be used at physician discretion.1
One order form for both monitoring and MRD detection, with fast results in 2 weeks.*
In a post-surgery setting,
Initiate MRD testing to inform critical
adjuvant therapy decisions.1
adjuvant therapy decisions.1
Up to
3 blood draws,
3 blood draws,
starting between 3 to
13 weeks after curative
intent therapy1
In a surveillance setting,
Monitor circulating tumor DNA (ctDNA) to identify
potential early recurrence.1
Integrate MRD testing into existing guideline-recommended surveillance for colorectal, breast, and lung cancers.†
Surveillance by cancer type6-8
Supplement current standard of care surveillance practices over the first 5 years.
Swipe to reveal full chart
Types of surveillance by cancer type6-8
Colorectal cancer:
history & physical exam, CEA,
and CT scan.Breast cancer:
history & physical exam and
mammography.Lung cancer:
history & physical exam and
chest CT scan.
In a surveillance analysis of patients receiving curative intent
treatment for CRC,
Guardant Reveal predicted distant
recurrence with up to 91% sensitivity.2
recurrence with up to 91% sensitivity.2
In a preliminary analysis of a limited cohort of patients with
early-stage breast cancer who experienced distant recurrence,
Guardant Reveal demonstrated 85% sensitivity
and 100% specificity.3,9‡
A retrospective study of patients at 3 years post-diagnosis
demonstrated3:
The pilot study was focused on evaluating Guardant Reveal and its association with breast cancer recurrence.
47 plasma samples from 38 patients with early-stage breast cancer (all subtypes) were collected through the BRandO BiO Registry at 12 or 36 months post-diagnosis and/or at the time of clinical recurrence.
All recurrence statistics reported are from patients who exhibited distant recurrence.
| Time of diagnosis (Number of samples) | 12 months§ (n=10) | 36 months (n=14) | At recurrence (n=19) |
|---|---|---|---|
| Clinical status | Recurred later | One recurred later||; 14 had no recurrence | Recurred |
| Sensitivity (distant recurrence) | 4/5 (80%) | 1/1 (100%) | 10/12 (83%) |
| Specificity | 14/14 (100%) |
One order form can cover both monitoring and MRD detection with results delivered as soon as 2-3 weeks.*
Comprehensive support across the cancer continuum.
Covered by Medicare
For patients with stage II or III CRC whose testing is initiated within 3 months following curative intent therapy.
Easy and Convenient Sample Collection
A mobile phlebotomy service makes sample collection as easy and convenient as possible by meeting patients at their location.
Important Note: The Guardant Reveal on Infinity test was developed, and its performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Guardant Reveal on Infinity is a Laboratory Developed Test (LDT). This test has not been cleared or approved by the US FDA.
*Turnaround time (TAT) is from sample receipt to result.
†For invasive carcinomas and inflammatory breast cancers and non-small cell lung cancer (adenocarcinoma, large cell, and squamous).
‡Sensitivity was calculated based on samples collected before or at recurrence.3
§Samples were collected a median of 11.9 months prior to clinical recurrence (range: 1.8-26.4 months).3
||One ctDNA+ patient did not have a second sample collected at time of recurrence (the other 4 were positive at time of recurrence)—hence 13 total patients experienced clinical recurrence, and 11 had ctDNA detected at or before the time of clinical recurrence detection.3.
References: 1. Backgrounder: Guardant Reveal™ Liquid Biopsy Test. Guardant Health, Inc. Redwood City, CA. 2. 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 3. 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 4. 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. GuardantINFINITY™ Specification Sheet. Guardant Health, Inc. Redwood City, CA. 6. Colorectal cancer – follow-up care. Cancer.Net®. Published June 25, 2012. Accessed June 29, 2023. https://www.cancer.net/cancer-types/colorectal-cancer/follow-care 7. Living as a breast cancer survivor. American Cancer Society. Accessed June 29, 2023. https://www.cancer.org/cancer/breast-cancer/living-as-a-breast-cancer-survivor.html 8. Schneider BJ, Ismaila N, Aerts J, et al. Lung cancer surveillance after definitive curative-intent therapy: ASCO guideline. J Clin Oncol. 2020;38(7):753-766. doi:10.1200/JCO.19.02748 9. NCI Dictionary of Cancer Terms. National Cancer Institute. Accessed June 29, 2023. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/early-stage-breast-cancer