Guardant Health’s Shield multi-cancer detection (MCD) test has received breakthrough device designation from the US Food and Drug Administration (FDA).
This blood-based test, aimed at screening multiple types of cancer in individuals aged 45 or older at average cancer risk, covers cancers such as bladder, colorectal, oesophageal, gastric, liver, lung, ovarian, and pancreas.
The FDA’s breakthrough devices programme aims to accelerate the development and review process for devices that may offer significant advances in the diagnosis or treatment of life-threatening diseases.
The Shield MCD test’s designation by the FDA follows its recent selection by the National Cancer Institute for the Vanguard Study that evaluates emerging MCD technology. This decision was based on the test’s performance in predicting cancer presence and origin.
Guardant Health co-founder and co-CEO 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.”
At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant Health presented validation data showing the Shield MCD test achieved 98.6% specificity and 75% sensitivity. This was across various tumour types, with a cancer signal origin accuracy of 92%.
Earlier this week, Guardant Health announced promising results from the Phase III SERENA-6 trial sponsored by AstraZeneca. The trial demonstrated the clinical utility of the Guardant360 CDx test in detecting emergent resistance in breast cancer therapy.
According to study findings presented at the same ASCO meeting and published in The New England Journal of Medicine, AstraZeneca’s camizestrant reduced risk of disease progression or death by 56% in patients with HR-positive breast cancer with emerging ESR1 tumour mutations detected by Guardant360 CDx.
The SERENA-6 trial is a global, double-blind, registrational study, which is using a ctDNA-guided approach to identify endocrine resistance and adjust therapy before radiological disease progression.
