Guardant Shield™
Multi-Cancer Detection
A single blood draw is used to analyze cancer-associated methylation signals in cell-free DNA (cfDNA), helping identify molecular signals that may warrant further medical evaluation.
Multi-Cancer Signal Analysis
Covers 10 cancer types that are common or clinically important for early detection.
Standard Blood Draw
Whole blood is collected using designated Streck Cell-Free DNA BCT® tubes.
Methylation Signal Analysis
Analyses cancer-associated epigenetic methylation patterns in cell-free DNA.
Reporting Time
Once the sample reaches the Guardant Health laboratory, results typically take approximately 2–3 working weeks.
ABOUT SHIELD™ MCD
What Is a Multi-Cancer Blood Test?
Small amounts of cell-free DNA (cfDNA) circulate in the bloodstream. Both normal cells and cancer cells can release DNA fragments into blood, and cancer-derived DNA may carry distinct molecular features, including abnormal methylation patterns.
Guardant Shield™ MCD does not simply look for a single gene mutation. It analyzes cancer-associated methylation signals in cfDNA.
The test is intended to help identify cancer-associated signals that may require further investigation and, when a signal is detected, provide information about the possible Cancer Signal Origin.
Important: Shield™ MCD does not diagnose cancer from a single blood draw. A positive result requires further confirmatory evaluation such as imaging, endoscopy, specialist assessment, or pathology.
10 CANCER TYPES
Which Cancer Types Does Shield™ MCD Cover?
The current Hong Kong version covers the following 10 cancer types. Sensitivity may vary substantially by cancer type and disease stage.
STUDY PERFORMANCE
How Has the Test Performed in Studies?
A blinded case-control study reported by Guardant Health evaluated Shield™ MCD across 10 cancer types. The figures below should be interpreted in the context of the study design and differences among cancer types.
Overall Sensitivity
Among samples from individuals known to have cancer, approximately 60% were identified by the test.
Overall Specificity
Among control samples from individuals without cancer, approximately 98.5% did not show a positive cancer signal.
Cancer Signal Origin Accuracy
In the study, the accuracy of the primary or secondary Cancer Signal Origin prediction was approximately 89%.
WHO MAY CONSIDER ASSESSMENT
Who May Consider Further Assessment?
Suitability for Shield™ MCD should be considered in the context of age, symptoms, cancer history, and existing cancer screening arrangements.
Age 45 or Above
Individuals who wish to explore multi-cancer blood testing in addition to their existing health checks and cancer screening.
No Known Cancer Diagnosis
Shield™ MCD is primarily intended for individuals who have not been diagnosed with cancer, rather than for monitoring an existing cancer diagnosis.
Seeking Additional Early Detection Information
Particularly for individuals who wish to understand whether blood-based cancer signal information may complement existing organ-specific screening.
Integration into Routine Health Management
Following professional medical assessment, MCD may be considered alongside existing health checks and standard cancer screening programmes.
When Should MCD Not Replace Formal Diagnostic Evaluation?
If there is unexplained weight loss, persistent bleeding, an abnormal lump, prolonged cough or coughing up blood, persistent abdominal pain, a significant change in bowel habits, or abnormal imaging or blood test findings, formal medical assessment directed at the symptoms or abnormal findings is more appropriate. Pregnant individuals and those already diagnosed with cancer are also not generally considered part of the intended population for Shield™ MCD screening.
BMS ASSESSMENT PATHWAY
BMS Guardant Shield™ MCD Assessment Pathway
From determining suitability to blood collection, laboratory analysis, and result interpretation, the focus is on a complete assessment and follow-up pathway rather than simply providing a laboratory report.
Medical Assessment
Review age, general health status, personal and family cancer history, as well as any existing cancer screening arrangements.
Assess Suitability for MCD
Determine whether there is an existing cancer diagnosis, relevant symptoms, or other medical concerns that should be addressed first.
Blood Sample Collection
Four 10 mL whole-blood samples are collected using Guardant-designated Streck Cell-Free DNA BCT® tubes.
Laboratory Analysis
Samples are sent to the Guardant Health laboratory for analysis of cancer-associated methylation signals in cfDNA.
Report and Medical Interpretation
Results are typically available in approximately 2–3 working weeks, followed by discussion of whether further imaging, endoscopy or specialist assessment may be appropriate.
RESULT INTERPRETATION
What Might the Results Mean?
Shield™ MCD results need to be interpreted in the context of the individual’s medical background. Neither a positive nor a negative result is a final diagnosis.
Cancer Signal Detected
This means that cancer-associated methylation signals have been identified in the blood sample. The report may also provide information on the possible Cancer Signal Origin.
No Cancer Signal Detected
This means that no cancer signal meeting the test's detection criteria was identified in this blood sample.
Some early-stage cancers may release only very small amounts of DNA into the bloodstream, and sensitivity may vary between different cancer types. Shield™ MCD also covers only specified cancers.
Shield™ MCD ≠ Full-Body Cancer Diagnosis
Guardant Shield™ MCD can provide blood-based information on signals associated with multiple cancer types, but it cannot independently answer the following questions:
SHIELD™ MCD VS COGENESIS®
How Is Shield™ MCD Different from CoGenesis® Pan-Cancer?
Looking for Cancer Signals That May Be Present Now
Analyses cfDNA methylation patterns in the blood to identify cancer-associated signals that may warrant further medical investigation.
Assessing Inherited Cancer Risk
Analyses germline DNA for genes associated with hereditary cancer to assess whether an individual carries inherited genetic variants linked to an increased risk of certain cancers.
REGULATORY STATUS
How Should Breakthrough Device
Designation Be Understood?
Shield™ MCD has received FDA Breakthrough Device Designation, a program intended to support more efficient development and review interaction for certain medical devices with the potential to improve the diagnosis or management of serious conditions.
Breakthrough Device Designation is not the same as FDA approval for multi-cancer screening.
The Shield product currently approved by the FDA is the colorectal cancer screening version for average-risk adults aged 45 and older. BMS Clinic clearly distinguishes between Shield CRC and Shield MCD in terms of intended use and regulatory status.
WHY BMS CLINIC
More Than “One Blood Test for 10 Cancers”
What matters is who is appropriate for testing, what the result means, and how the result should be followed up.
Medical Assessment
Review the individual's health status, cancer history, age and existing cancer screening arrangements before assessing whether MCD may be appropriate for further consideration.
Selecting the Appropriate Test
MCD is not appropriate for everyone and does not replace targeted investigations arranged because of symptoms, high-risk factors or other specific medical needs.
Professional Result Interpretation
A detected cancer signal requires further evaluation, while no detected signal does not completely exclude cancer. Results should be interpreted in the context of the individual's overall medical background.
Follow-Up Investigation Pathway
If a cancer-associated signal is detected, the Cancer Signal Origin, personal medical history and individual circumstances may help guide further imaging, endoscopy or specialist assessment.
This page is provided for medical education, general health information, and service introduction purposes only. It does not replace cancer diagnosis, personalised risk assessment, or medical advice from a doctor or other qualified healthcare professional.
Guardant Shield™ Multi-Cancer Detection is a blood-based multi-cancer test that analyses cancer-related methylation signals in cfDNA. A cancer signal detected result does not constitute a cancer diagnosis and requires appropriate confirmatory evaluation, which may include imaging, endoscopy, pathology, or other investigations based on the suspected signal origin and individual circumstances. A no cancer signal detected result does not completely rule out cancer and should not replace routine cancer screening recommended according to age, sex, medical history, and individual risk factors.
The FDA Breakthrough Device Designation for Shield™ MCD does not constitute FDA approval for multi-cancer screening and should be distinguished from the FDA-approved Shield indication for colorectal cancer screening in a specified population. Test performance may vary according to cancer type, disease stage, and the population being tested. Whether Shield™ MCD is appropriate and any subsequent medical follow-up should be determined by a qualified healthcare professional based on individual circumstances.
Learn More About Whether Multi-Cancer Blood Testing May Be Suitable for You
Guardant Shield™ MCD analyzes cancer-associated methylation signals in blood-based cfDNA to provide additional information for multi-cancer early detection. Whether the test is appropriate, and what further investigations may be needed after the result, should be assessed together with age, personal and family history, current symptoms, and existing cancer screening by a healthcare professional.
References
Official Product Information and Asia Launch of Guardant Shield™ Multi-Cancer Detection:
- Guardant Health. Guardant Health Launches Shield Multi-Cancer Detection (MCD) Test in Multiple Markets in Asia with Manulife Partnership. March 16, 2026.
- Guardant Health. Guardant Health Presents Data Demonstrating Strong Performance of Shield Multi-Cancer Detection Test Across 10 Tumor Types. Presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. April 29, 2025.
cfDNA Methylation and the Principles of Multi-Cancer Early Detection:
- National Cancer Institute (NCI). Definition of Multi-Cancer Detection Test. NCI Dictionary of Cancer Terms.
- Current Challenges of Methylation-Based Liquid Biopsies in Cancer Diagnostics. 2024. PMID: 38893121.
- Early Detection of Multiple Cancers: The Era of Methylation-Based Liquid Biopsy. 2026. PMID: 42388617.
Shield™ MCD Performance Across 10 Cancer Types and Cancer Signal Origin:
- Guardant Health. Evaluation of a Plasma Cell-Free DNA Methylation-Based Multi-Cancer Detection Test. AACR Annual Meeting 2025. Overall Sensitivity 60% · Specificity 98.5% · Primary or Secondary Cancer Signal Origin Accuracy 89%.
- Guardant Health. Guardant Health Shield Platform Selected for Inclusion in National Cancer Institute’s Vanguard Study to Evaluate Emerging Technologies for Multi-Cancer Detection. January 7, 2025.
- Guardant Health. First Patient Enrolled in National Cancer Institute’s Vanguard Study Evaluating Guardant Health’s Shield Multi-Cancer Detection Test. July 15, 2025.
Clinical Role of Multi-Cancer Detection, Positive and Negative Results, and Standard Screening:
- National Cancer Institute (NCI). Questions and Answers About Multi-Cancer Detection Tests. Cancer Screening Research Network.
- National Cancer Institute (NCI). Cancer Screening Overview (PDQ®) — Multi-Cancer Detection. Health Professional Version.
- National Cancer Institute (NCI). Questions and Answers About the Vanguard Study. Multi-Cancer Detection Tests.
- National Cancer Institute (NCI). What Cancer Screening Tests Check for Cancer? Multi-Cancer Detection Tests.
FDA Breakthrough Device Designation and FDA Approval of Shield for Colorectal Cancer Screening:
- Guardant Health. FDA Grants Breakthrough Device Designation to Guardant Health’s Shield Multi-Cancer Detection (MCD) Test. June 3, 2025.
- U.S. Food and Drug Administration (FDA). Breakthrough Devices Program. Information on Breakthrough Device Designation, Development, Review and Marketing Authorization.
- U.S. Food and Drug Administration (FDA). Shield — P230009. FDA-Approved Blood-Based Colorectal Cancer Screening Test for Average-Risk Adults Aged 45 Years and Older. Approval Date: July 26, 2024.
- U.S. Food and Drug Administration (FDA). Premarket Approval P230009 — Shield. Intended for Colorectal Cancer Screening in Average-Risk Individuals Aged 45 Years or Older.