Guardant Shield™
Blood-based colorectal cancer screening for average-risk adults age 45+.
Guardant Shield™ is a qualitative, blood-based colorectal cancer screening test that analyzes cell-free DNA (cfDNA) signals from plasma. It is intended for individuals at average colorectal cancer risk who are 45 years or older.
A positive Shield result requires follow-up colonoscopy. A negative result does not rule out colorectal cancer or advanced adenoma, and routine guideline-based screening should continue at recommended intervals.
- Average-risk adults age 45+ who are due for colorectal cancer screening.
- Patients and providers considering guideline-recommended non-invasive screening options.
- Clinical settings where a blood-based screening option may improve screening adherence.
- Individuals with personal history of colorectal cancer, adenomas, or related cancers.
- Individuals with family history of colorectal cancer in one or more first-degree relatives.
- Individuals with recent positive results on other CRC screening tests (per label-specified intervals).
- Individuals with high-risk conditions (e.g., inflammatory bowel disease, familial adenomatous polyposis, Lynch syndrome, and other hereditary colorectal cancer syndromes).
- Use as a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk patients.
| Step / Test | Accuracy | Notes |
|---|---|---|
| Sensitivity | 83.1% | ECLIPSE Study |
| Specificity | 89.6% | ECLIPSE study |
Blood plasma in Guardant Shield kit
40 mL peripheral blood collected into 4 x Streck Cell-Free DNA BCT tubes by a licensed healthcare professional, using the Guardant Shield Blood Collection Kit instructions for use.
Collection, packaging, and shipping must follow the Guardant Shield Blood Collection Kit (BCK) Instructions for Use, including tube type and transport requirements.
Order using a completed and signed Test Requisition Form (TRF) by an authorized clinician, with specimen collection and shipping per Guardant Shield BCK instructions. In Hong Kong, ordering support is available through Codex Genetics.
Samples must be collected and submitted through an authorised healthcare provider.
- Collect blood into Streck Cell-Free DNA BCT® tubes (room-temperature stable up to 14 days).
- Do NOT centrifuge. Ship tubes intact at ambient temperature; avoid freezing or >37°C.
- Include completed test requisition form. Address: Unit 220, 2/F, Building 16W, HKSTP, Pak Shek Kok, NT, Hong Kong.
Results are qualitative (positive or negative). A positive result raises concern for colorectal cancer or advanced adenoma and should be followed by colonoscopy. A negative result indicates no detected colorectal cancer-associated signal at testing time, but does not exclude colorectal cancer or advanced adenoma.
Screening adherence is a major barrier in colorectal cancer prevention and early detection. A blood-based screening option may help increase participation for some patients, but test limitations must be discussed clearly.
In the ECLIPSE study, Shield showed 83.1% sensitivity for colorectal cancer and 89.6% specificity for advanced neoplasia. Stage I and advanced adenoma detection are lower than for later-stage disease, so negative results do not exclude clinically significant findings.
— FDA Approval, 2024Guardant Shield™ received FDA approval as the first blood-based colorectal cancer screening test for average-risk adults.
Hong Kong-based molecular diagnostics laboratory specialising in clinical genomics, precision oncology, and rare disease diagnosis. Accredited to ISO 27001 and GenQA standards.
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