Why Is Cancer Diagnostic Guardant Health Stock Trading Higher On Tuesday?

Guardant Health, Inc. (NASDAQ:GH) stock is trading higher on Tuesday after the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation to the company’s Shield multi-cancer detection (MCD) test.

The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types, including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test. The blood-based test exhibits high specificity, clinically meaningful sensitivity, and strong cancer signal of origin accuracy across multiple tumor types.

Also Read: Guardant Health, Pfizer Collaborate To Develop New Cancer Therapies Using Liquid Biopsy Platform

Data from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity for bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic cancers.

Primary or secondary CSO (cancer signal origin) accuracy was 92%.

On Monday, the National Comprehensive Cancer Network (NCCN) included the Shield blood test in its updated colorectal cancer (CRC) screening guidelines.

The Shield test detects CRC signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA).

The updated NCCN CRC Screening Guidelines reflect the addition of Shield with a recommendation for testing every three years.

In its guideline update, the NCCN cited Guardant’s ECLIPSE study evaluating Shield’s performance compared to a screening colonoscopy.

One of the largest studies of its kind and published in the New England Journal of Medicine (NEJM), ECLIPSE demonstrated that the Shield blood test is highly effective in detecting CRC, with a sensitivity of 83%.

Price Action: GH stock is up 10.4% at $46.49 at the last check on Tuesday.

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