In this context, I am pleased to report that we have one more colorectal cancer screening tool.

The U.S. Food and Drug Administration has approved Guardant Health’s blood test for detecting colorectal cancer.

Current Colorectal Screening Change

Colorectal cancer screening typically involves stool-based tests or optical/visualization tests, each aiming to detect the disease before symptoms arise.

Recognizing an increasing risk in younger adults, the U.S. Preventive Services Task Force updated its guidelines in 2021, lowering the recommended screening start age from 50 to 45.

This decision stemmed from mounting evidence revealing a concerning rise in colorectal cancer cases among adults under 50.

Statistical modeling further supported this change, indicating that initiating screening at 45 could potentially extend lifespans compared to the previous starting age of 50.

Colorectal Screening Summary

Here are the recommendations in graphic form:

Colorectal cancer screening encompasses various methods, broadly categorized into stool-based tests (like fecal occult blood test (FOBT), fecal immunochemical test (FIT), and FIT-DNA) and optical/visualization tests (such as sigmoidoscopy, colonoscopy, and virtual colonoscopy).

These diverse screening tools play a crucial role in detecting colorectal cancer before the onset of symptoms, significantly improving survival rates through early diagnosis and timely treatment.

Here’s a link to the many ways you can screen:

Colorectal Cancer: Screening

www.uspreventiveservicestaskforce.org

Colorectal Cancer Screening Blood Test: FDA Approval

Previously limited as a test with a self-pay price of $895, Shield’s U.S. Food and Drug Administration approval marks a significant milestone.

This pivotal decision paves the way for potential Medicare coverage, making this groundbreaking blood test for colorectal cancer screening accessible to a wider population, particularly older adults.

Blood Test Accuracy

While Guardant Health’s Shield blood test, which detects tumor DNA in the bloodstream, has shown promise with an 83 percent effectiveness in identifying colorectal cancers, it primarily excels in detecting later-stage cancers.

The test’s lower sensitivity for early-stage polyps (13 percent) necessitates regular screenings at least every three years, starting at age 45.

It’s important to note that a positive result does not equate to a diagnosis requiring further confirmation through a colonoscopy.

This test marks the second approved blood one for colon cancer screening, following Epigenomics’ Epi proColon, which faces challenges regarding its accuracy and insurance coverage.

My Take

This landmark decision opens the door for potential Medicare coverage in the United States, making colorectal cancer screening more accessible and affordable for older adults.

Do I think this blood test will replace colonoscopies?

No, but hopefully, it will boost the suboptimal screening rates in the United States.

Colonoscopy Is The Gold Standard

Beyond detecting tumors, colonoscopies play a preventive role by removing precancerous polyps.

However, the inconvenience of scheduling and preparation deters some individuals.

Guardant Health’s Shield blood test offers a simpler alternative with a straightforward blood draw.

The New Blood Test Available Soon

The company aims to make this screening option available soon. Hopefully, we will see increasing adherence to recommended colorectal cancer screening guidelines for healthy adults aged 45 to 75.

Shield is not the first blood for colorectal cancer screening. Epigenomics’ Epi proColon was approved in 2016.

However, the proColon test is not often used. Its accuracy is suboptimal, and there is a lack of insurance coverage in the U.S.

Summary

In conclusion, Guardant Health’s recent approval of its blood test for detecting colorectal cancer marks a significant milestone in improving accessibility to screening options for older adults.

While this blood test offers a simpler alternative to colonoscopies, I should note that colonoscopies remain the gold standard for detecting tumors and preventing the development of precancerous polyps.

It’s important for you to consider discussing colorectal cancer screening options with your healthcare providers to make informed decisions regarding your health.

The evolving landscape of colorectal cancer screening provides hope for increased adherence to recommended guidelines, ultimately contributing to improved early detection and patient outcomes.

As an oncologist, I would love to see fewer patients.

Please don’t get me wrong: I am not directly advocating for this particular new blood test; rather, I am pleased with any reasonable maneuver that nudges folks who don’t get recommended colorectal cancer screening.

What has been your colorectal cancer screening experience?

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