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Blood Test for Colon Cancer Nears FDA Approval: A More Convenient Option for Early Detection?

For many people, colon cancer screening can be a daunting prospect. Traditional colonoscopies, while highly effective, are invasive and require anesthesia. 


However, a new era of colon cancer screening might be on the horizon. A blood test developed by Guardant Health, a biotechnology company, is nearing FDA approval in the US. This could offer a more convenient and potentially more widely used option for early detection.


The Need for a New Approach

Currently, several options exist for colon cancer screening in average-risk individuals. These include:

  • Annual or triennial stool tests

  • Colonoscopies every 10 years

  • Virtual colonoscopies every 5 years

  • Sigmoidoscopies every 5 years (examining the lower colon)

While effective, these methods have limitations. Stool tests can be inconvenient and require sample collection. Colonoscopies are invasive and expensive.


The Promise of a Blood Test

Guardant Health's Shield blood test offers a potentially more accessible solution. It's already available as a laboratory-developed test (LDT), but FDA approval would make it more widely covered by insurance and accepted as a primary screening option.


Safety and Effectiveness

A recent FDA advisory panel meeting reviewed data on the Shield test. The panel voted favorably, finding the test:

  • Safe for use in people who meet screening criteria (8-1 vote)

  • Effective for use in those meeting the criteria (6-3 vote)

  • Offering benefits that outweigh the risks (7-2 vote)


Not a Replacement, but an Addition:

While the Shield test represents a significant advancement, it's not intended to replace existing screening methods. Rather, it aims to be a non-invasive alternative, potentially increasing the number of people who get screened. This could lead to earlier detection and improved outcomes.


The Future of Blood Tests for Cancer

Guardant Health's test is just one example of the growing field of blood tests for cancer detection.  Several research teams are actively developing similar tests for various cancers.



The Road Ahead

The FDA will review the advisory panel's discussions and voting outcomes before making a final decision on Shield's approval. If approved, this blood test could become a valuable tool in the fight against colon cancer.

tests, while more convenient, can be messy and unpleasant.



Source: CNN

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