Guardant360 Reveal™

Identifies recurrence and guides critical adjuvant therapy decisions as soon as
2-3 weeks post-surgery.1

Guardant Reveal™ is the first liquid-only test
to detect minimal residual disease (MRD) in
colorectal cancer, now available for breast and
lung cancers.1-4

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  • For early-stage,
    post-surgery patients.1

  • Maximize sensitivity up to 91% with surveillance draws.2

  • Results in
    2 to 3 weeks.*

In a post-surgery setting,
Initiate MRD testing to inform critical
clinical decisions.1

Up to
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

  • Testing time points coincide with the current surveillance guidelines and may be used as a supplement to standard-of-care monitoring for colorectal, breast, and lung cancers.†

Surveillance by cancer type5-7

Clinical surveillance time points over
the first 5 years

Swipe to reveal full TABLE

Types of surveillance by cancer type5-7

  • 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 colorectal cancer (CRC),

Guardant Reveal predicted distant
recurrence with up to 91% sensitivity.2

Graphic showing that sensitivity rates increase from 56% with one blood draw to 69% with two blood draws and up to 91% with multiple blood draws.
Read the study

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.3,8‡

A retrospective study of patients at 3 years post-diagnosis
demonstrated3:

Graphic shows that Guardant Reveal offers 3.8 to 18.6 months of additional lead time to clinical detection of distant recurrence.
  • 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%)

Guardant360 Reveal™

One order form can cover both monitoring and MRD assessment with results delivered in as few as 2 to 3 weeks.

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Comprehensive support
across the cancer continuum.

  • Guardant Portal

    Covered by Medicare

    For patients with stage II or III CRC whose testing is initiated within 3
    months following curative intent therapy.

    Contact client services ›
  • Guardant Portal

    Guardant Portal

    Easy access to test ordering and
    management with simple order forms.

    Clear, concise reports.

    Sign in now ›
  • Collection

    Easy and Convenient Sample Collection

    A mobile phlebotomy service makes
    sample collection as easy and
    convenient as possible by meeting
    patients at their location.

    Inquire about mobile phlebotomy ›

Important Note: The Guardant Reveal 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 refers to Guardant Reveal Laboratory Developed Test (LDT). This test has not been cleared or approved by the US FDA.

*Turnaround time (TAT) varies by cancer type. TAT for colorectal cancer is within 2 weeks of sample receipt. TAT for breast and lung cancers is within 3 weeks of sample receipt.

†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. Palo Alto, 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 November 1, 2022. 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. Colorectal cancer – follow-up care. Cancer.net. Published June 25, 2012. Accessed November 8, 2022. https://www.cancer.net/cancer-types/colorectal-cancer/follow-care 6. Living as a breast cancer survivor. American Cancer Society. Accessed November 8, 2022. https://www.cancer.org/cancer/breast-cancer/living-as-a-breast-cancer-survivor.html 7. 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 8. NCI Dictionary of Cancer Terms. National Cancer Institute. Accessed October 31, 2022. https://www.cancer.gov/
publications/dictionaries/cancer-terms/def/early-stage-breast-cancer