Guardant Health Shield Blood Test for Colorectal Cancer Receives FDA Advisory Panel Endorsement

Guardant Health’s Shield Blood Test for Colorectal Cancer Receives FDA Advisory Panel Endorsement


Guardant Health, a prominent player in precision oncology, has taken a significant step forward with its Shield blood test for colorectal cancer screening. On May 23, 2024, an FDA advisory committee recommended the approval of the Shield test, marking a pivotal moment for the company’s innovative approach to cancer diagnostics.

Revolutionizing Colorectal Cancer Screening

The Shield blood test is designed for adults aged 45 and older who are at average risk for colorectal cancer. It offers a non-invasive alternative to traditional screening methods such as colonoscopies and stool tests. This recommendation comes after extensive clinical trials, including the ECLIPSE study, which evaluated over 7,800 participants. The study demonstrated that the Shield test could detect 83% of colorectal cancers with a specificity of 90%, highlighting its potential to identify cancer early when it is most treatable.

AmirAli Talasaz, co-CEO of Guardant Health, expressed optimism about the test’s ability to overcome barriers to current screening methods. “The Shield blood test provides a more convenient screening option that will detect colorectal cancer in its early stages, significantly improving patient outcomes,” Talasaz said.

Addressing Unmet Needs in Colorectal Cancer Screening

Colorectal cancer is the third most common cancer globally, with an estimated 1.9 million new cases each year. It is also the second-leading cause of cancer-related deaths in the United States, with more than 150,000 new diagnoses annually​​. Despite the effectiveness of early treatment, a significant number of individuals avoid traditional screening methods due to discomfort and inconvenience, leading to late-stage diagnoses and higher mortality rates.

Guardant Health estimates that 75% of colorectal cancer deaths occur in individuals who are not up-to-date with their screenings. The Shield test aims to increase compliance by offering a simpler, less invasive option that can be performed with a single blood draw in a healthcare provider’s office.

Market Potential and Future Directions

The global market for colorectal cancer diagnostics was valued at approximately $2.5 billion in 2020 and is projected to grow significantly. The approval of the Shield test could position Guardant Health as a leader in this expanding market. The company’s strategic focus on non-invasive testing aligns with broader healthcare trends emphasizing early detection and patient-centered care.

Beyond colorectal cancer, Guardant Health has ambitious plans to expand its diagnostic capabilities to other cancers, including lung and pancreatic cancer. This expansion is part of a broader vision to revolutionize cancer screening and improve outcomes across multiple types of cancer. Talasaz noted, “Colorectal cancer screening is the start of this journey. We will soon expand into multi-cancer screening, where we believe cancer screening can save lives.”​

Looking Forward

The FDA advisory panel’s recommendation for the Shield blood test marks a significant milestone for Guardant Health. As the company moves towards full FDA approval and broader market adoption, it stands to make a substantial impact on cancer screening and patient care. The Shield test’s non-invasive nature and high accuracy promise to improve compliance with screening guidelines, ultimately reducing colorectal cancer mortality and paving the way for advancements in cancer diagnostics.

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