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[FDA breakthrough device designation] Shield ™ MCD
Guardant Shield™ CRC was approved by the U.S. Food and Drug Administration (FDA) on July 29, 2024, for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease.
The Guardant Health’s MCD test* is a bloodbased diagnostic test, which means it involves a routine blood draw and has no inherent safety concerns for the general population. As with any blood test, risks are minimal and typically limited to minor discomfort or bruising at the draw site.A version of this MCD test* has received US FDA breakthrough device designation^.
The Guardant Health’s MCD test* is intended to complement, not replace guideline recommended cancer screening tests.
Individuals with positive results should follow healthcare provider recommendations for diagnostic follow-up and evaluation. A negative result does not eliminate the possibility that cancer is present or will occur in the future.
Individuals should continue to participate in age-appropriate guideline directed cancer screening programs. These findings should be interpreted in the context of other clinical information, and laboratory and imaging
^The US FDA Breakthrough Device designation referenced includes eight cancer types—bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic cancer.1
1. Guardant Health. FDA Grants Breakthrough Device Designation to Guardant Healthʼs Multi-Cancer
Detection (MCD) Test. Published June 3, 2025.
Guardant Health 提供的多種癌症(MCD)檢測*是
一項以血液為基礎的檢測，旨在檢測 10 種癌症，包括：膀胱癌、乳癌、大腸癌、食道癌、胃癌、肝癌（即肝細胞癌）、肺癌、胰臟癌、前列腺癌及卵巢癌。
對於尚無症狀的人士，癌症篩查有助及早發現癌症。當症狀出現時，癌症很可能已處於較晚期階段 1。及早偵測癌症的徵兆，可提高存活
率並降低死亡率。¹⁻³ 整體而言，MCD 檢測有望透過單項血液檢測提高篩查率，從而提升偵測癌症的能力。2Guardant Health 多種癌症(MCD)檢測*不適用於孕婦，以及曾被診斷患有癌症的人士。您的臨床資格將由您已安排約診的醫務人員確定。
進行此檢測並無其他限制。Guardant Health 的多種癌症(MCD)檢測*旨在作為常規癌症篩查的補充，並不能取代按年齡建議進行的標準癌症篩查。
參考資料：
1. Madar, S.; Amor, R.E.; Furman-Assaf, S.; Friedman, E. Innovative Approaches to Early Detection of Cancer-Transforming Screening for Breast, Lung, and Hard-toScreen Cancers. Cancers 2025, 17, 1867. https://doi.org/10.3390/cancers171118672. Carbonell C, Hutchinson JM, Hilsden RJ, Yang H, Brenner DR. Blood-Based MultiCancer Early Detection Tests (MCEDs) as a Potential Approach to Address Current Gaps in Cancer Screening. Cancer Control. 2024 Jan-Dec;31:10732748241307360. doi: 10.1177/107327482413073603. Montena, J. (2024). Early cancer diagnosis: A crucial step toward better outcomes. Journal of Cancer Diagnosis, 2024(1), 1–5.
