Revolutionary Blood Tests for Cancer Detection Gain FDA Approval, Offering Hope for Early Diagnosis and Treatment

October 18, 2025
Revolutionary Blood Tests for Cancer Detection Gain FDA Approval, Offering Hope for Early Diagnosis and Treatment
  • Case studies, like the diagnosis of a 77-year-old man with Stage 2 colon cancer through routine blood tests, demonstrate the potential of blood tests to enable early detection, which significantly improves survival rates.

  • Ongoing clinical trials aim to evaluate blood tests for pancreatic cancer and assess whether innovations like Shield can increase screening rates among underserved populations, with hopes of integrating these tests into routine care soon.

  • While early detection through blood tests has great potential, challenges such as false positives and the lack of effective treatments for certain early cancers mean that screening must be carefully managed to avoid unnecessary anxiety and procedures.

  • Developments in blood tests for pancreatic cancer, focusing on molecules like microRNAs, could enable earlier diagnosis, which is crucial given the typically late detection and low survival rates associated with this disease.

  • The Shield test detects small DNA fragments and methylation differences specific to colon cancer, achieving an 83% detection rate in large studies, and could complement traditional screening methods to improve early detection.

  • Guardant's initial success was with a blood test approved in 2020 for late-stage cancer treatment planning, using cancer DNA fragments in blood samples, paving the way for earlier detection technologies.

  • Recent advancements in blood tests for pancreatic and other cancers focus on detecting microRNAs and molecules in blood, with studies showing detection rates as high as 97%, aiming for earlier diagnosis and treatment.

  • Guardant Health has developed the first FDA-approved liquid biopsy blood test for colon cancer, called Shield, which was approved in July 2024 and is now covered by Medicare, offering a non-invasive screening option that detects DNA fragments from cancer or precancerous cells.

  • This breakthrough in early detection is part of Guardant's broader vision to develop multi-disease blood tests capable of identifying various health conditions, including multiple cancer types, through comprehensive blood analysis.

  • Guardant's innovations represent a significant step toward more accessible, less invasive, and potentially more comprehensive cancer detection and health monitoring methods.

  • Blood-based liquid biopsies for various cancers, including breast, stomach, and pancreatic, are still in early stages but show promise despite challenges like lower detection rates and false positives.

  • Experts acknowledge that early detection of precancerous lesions remains difficult, and current blood tests may miss early signs such as polyps, highlighting the need for further validation.

  • The ultimate goal is to develop multi-disease, all-in-one blood tests that could identify various health issues, similar to a smartphone with multiple features, making health monitoring more comprehensive.

Summary based on 2 sources


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Sources

How Guardant developed a blood test for cancer

Business Insider • Oct 18, 2025

How Guardant developed a blood test for cancer

Could simple blood tests identify cancer earlier?

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