Guardant Health's MCD test earns FDA breakthrough designation
Guardant Health's Shield multi-cancer detection (MCD) test has secured the US Food and Drug Administration's (FDA) breakthrough device designation.
This methylation-based blood test is designed for the screening of various types of cancer in people who are 45 or above and are at a typical average cancer risk.
The tested cancers include colorectal, oesophageal, bladder, gastric, lung, liver, pancreas, and ovarian.
The FDA's designation for the MCD test follows its selection by the National Cancer Institute (NCI) for the Vanguard Study assessing the technology.
This test was selected based on its predictive performance for cancer presence and for identifying the origin of the cancer tissue.
At the 2025 American Society for Clinical Oncology Annual Meeting in Illinois, US, Guardant Health presented data from a case-control cohort of the Shield MCD test.
The findings demonstrated the test's specificity and sensitivity, along with accuracy in determining the cancer signal of origin across various types of tumours.
It exhibits 98.6% specificity and 75% sensitivity for detecting cancers, as per the data.
The sensitivity range for individual cancers varied between 62% and 96%, with primary or secondary cancer signal origin accuracy reaching 92%.
The breakthrough device designation is awarded to a select group of medical devices that show potential in treating or diagnosing life-threatening conditions compared to existing options.
Guardant Health co-CEO and co-founder AmirAli Talasaz said: 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system.
'This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.'
Last year, the company expanded its market reach by striking a deal to promote its range of liquid and tissue biopsy tests for cancer screening in the Middle East and North Africa region.
"Guardant Health's MCD test earns FDA breakthrough designation" was originally created and published by Medical Device Network, a GlobalData owned brand.
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