Guardant Reveal™ is a revolutionary blood-only liquid biopsy test that detects circulating tumor DNA (ctDNA) for minimal residual disease (MRD) assessment in early-stage colorectal, breast, and lung cancers. In addition to detection of MRD, Guardant Reveal is also available to monitor recurrence in previously diagnosed patients. Guardant Reveal is now covered for fee-for-service Medicare patients with Stage II or III CRC whose testing is initiated within three months following curative intent therapy.
The detection of ctDNA post-surgery for CRC patients can be a sign of the need for adjuvant chemotherapy. While 80% of Stage II CRC patients are cured with surgery alone, within 5 years approximately 10% of Stage II CRC patients and 30% of Stage III CRC patients recur.¹ Current clinicopathologic tools, like CEA, are limited in their ability to identify patients at high risk for recurrence.
In 2–3 weeks, Guardant's proprietary technology detects the presence of ctDNA mutations and methylation in blood. This blood-only test addresses the challenge of tissue insufficiency in the tumor-dependent approach that requires an initial sequencing of tumor tissue to guide cDNA detection.
Repeat testing in the surveillance setting offers more opportunity to detect ctDNA as an early sign of recurrence. In a study published in Clinical Cancer Research, Guardant Reveal reached 91% sensitivity to detect ctDNA in patients who had a blood draw within 4 months of recurrence.
In the surveillance setting, Guardant Reveal maximizes sensitivity for detecting ctDNA by simultaneously interrogating two complementary signals, genomic alterations and DNA methylation.
Tumors evolve and mutate over time. Unlike tests that rely on a static "snapshot" of a tumor, Guardant Reveal examines a wide range of genomic and epigenomic markers through a series of planned blood draws. This process allows for sensitive monitoring for recurrence in patients.
Guardant Reveal delivers results in 2-3 weeks, depending on tumor type, and does not require tissue to initiate, eliminating the delays associated with assays that require tissue and the challenge of inadequate tissue samples. In addition, Guardant Reveal can be initiated as soon as 3 weeks after surgery.
Offering easy access to your patients’ results and support services, the Guardant Portal provides everything you need for informed treatment planning, including:
• End-to-end support to manage billing
• On-call clinical support for you and your staff