Two New FDA-Approved Blood Tests for Colorectal Cancer: Shield by Guardant Health and Exact Sciences' FIT Test - Comparison, Effectiveness, and Implications

Newport Beach, California United States of America
Blood tests like Shield offer a more convenient alternative with quicker results, but may not be as effective in detecting precancerous polyps.
Colonoscopies are the gold standard for colorectal cancer screening but are invasive procedures requiring sedation and bowel preparation.
Exact Sciences' FIT test, a stool test, has a sensitivity rate of 92.3% and is covered under Medicare as a screening tool for colorectal cancer.
Guardant Health's Shield test detected 83% of colorectal cancers but is less effective in identifying precancerous polyps. Its price for the FDA-approved version has not been announced yet.
Two new blood tests for detecting colorectal cancer have been FDA-approved: Guardant Health's Shield and Exact Sciences' FIT Test.
Two New FDA-Approved Blood Tests for Colorectal Cancer: Shield by Guardant Health and Exact Sciences' FIT Test - Comparison, Effectiveness, and Implications

New Blood Tests for Colorectal Cancer Approved by FDA: What You Need to Know

Two new blood tests for detecting colorectal cancer have recently been approved by the Food and Drug Administration (FDA). These tests, Shield from Guardant Health and a fecal immunochemical test (FIT) from Exact Sciences, offer alternative options for colonoscopies in screening for this type of cancer. In this article, we will discuss these new tests, their accuracy rates compared to colonoscopies, and what they mean for colorectal cancer screening.

First Approval: Guardant Health's Shield Test

Guardant Health's Shield test has been available since 2022 but is not yet covered under Medicare. The FDA approval brings the test closer to gaining coverage under this insurance program. The test is recommended for adults aged 45 and older who are at an average risk for colorectal cancer.

According to a study, Shield detected 83% of colorectal cancers. While it may not be as effective as colonoscopies in detecting precancerous polyps, it is considered more convenient and less invasive than traditional screening methods. However, the self-pay price for the FDA-approved version of Shield has not been announced yet.

Second Approval: Exact Sciences' FIT Test

Exact Sciences' FIT test is a stool test that has been available since 2014 and is covered under Medicare. The FDA approval for this test means it can now be marketed as a screening tool for colorectal cancer, in addition to its current use as a follow-up test after an abnormal colonoscopy result.

The FIT test has a sensitivity rate of 92.3%, making it more effective than Shield at detecting colorectal cancers. However, it is less accurate in identifying precancerous polyps and may require additional testing to confirm positive results.

Comparing the Tests: Colonoscopies vs. Blood Tests

Colonoscopies are considered the gold standard for colorectal cancer screening due to their high accuracy rates in detecting both cancers and precancerous polyps. However, they are invasive procedures that require sedation and bowel preparation.

Blood tests like Shield offer a more convenient alternative, as they do not require bowel preparation or sedation. They also provide quicker results compared to colonoscopies.

However, it is important to note that blood tests may not be as effective in detecting precancerous polyps and may require additional testing for confirmation of positive results.

Conclusion: New Options for Colorectal Cancer Screening

The approval of these new blood tests provides more options for individuals who prefer less invasive screening methods or have difficulty undergoing colonoscopies. While they may not be as effective as colonoscopies in detecting precancerous polyps, they offer a more convenient and quicker alternative for colorectal cancer screening.

It is important to remember that regular screenings are crucial for early detection and prevention of colorectal cancer. Regardless of the method chosen, it is essential to follow up on any abnormal results with additional testing.


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Confidence

100%

No Doubts Found At Time Of Publication

Sources

92%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

Guardant's blood-based cancer test moves closer to Medicare coverage with FDA approval

Entertainment Variety Tv Site: https://www.yahoo.com/entertainment/tv-site/ Leroy Monday, 29 July 2024 23:17
  • Unique Points
    • Guardant Health's Shield test has been available since 2022 but is not covered under Medicare
    • Shield detected 83% of colorectal cancers in a study, while Cologuard had a sensitivity rate of 92.3%
  • Accuracy
    • ]The Shield test has been available since 2022[
    • Shield detected 83% of colorectal cancers in a study
    • The self-pay price of the FDA-approved version of Shield was not provided by Guardant
  • Deception (80%)
    The article contains selective reporting as it only mentions the detection rate of Guardant's Shield test without providing context about the study design and population. It also implies that Guardant's test is more convenient than Exact Sciences' Cologuard without explicitly stating this as a fact.
    • The test, known as Shield, has been available in the U.S. since 2022 for use by laboratories, but is not covered under Medicare.
  • Fallacies (95%)
    The author makes several statements in the article that are not fallacious. However, there is one instance of a dichotomous depiction when the author states 'Many people for different reasons are not going through that procedure [colonoscopies], and in the United States, we don’t have a lot more capacity to screen a lot more people through colonoscopy either.' This statement creates a false dichotomy between getting a colonoscopy and using Guardant's blood test for colorectal cancer screening. The author implies that these are the only two options available, when in fact there are other methods of screening as well. This is a fallacy because it oversimplifies the situation and limits the reader's understanding of the available options.
    • Many people for different reasons are not going through that procedure [colonoscopies], and in the United States, we don’t have a lot more capacity to screen a lot more people through colonoscopy either.
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

96%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

F.D.A. Approves Blood Test for Colon Cancer Detection

The Name Of The NZ Prefix. I PWA NZI.P.Was Dropped. Gina Kolata Monday, 29 July 2024 11:20
  • Unique Points
    • The Food and Drug Administration (FDA) has approved a new blood test for detecting colorectal cancer called Shield, made by Guardant Health.
    • Guardant Health will announce the list price of the Shield test within a week.
  • Accuracy
    • ]The Food and Drug Administration (FDA) has approved a new blood test for detecting colorectal cancer called Shield, made by Guardant Health.[
    • The Shield blood test can find early-stage colorectal cancers that are usually curable.
    • Regular screening for colorectal cancer can prevent up to 73 percent of related deaths, but as many as 25 to 50 percent of people who should be getting screened are not.
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

95%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

FDA approves new blood test to detect colorectal cancer

WMUR News Channel Arielle Mitropoulos Monday, 29 July 2024 20:49
  • Unique Points
    • The FDA has approved a new blood test called Shield to screen for colorectal cancer.
    • The blood test is recommended every three years for people over the age of 45 with an average risk of colon cancer.
  • Accuracy
    • ]The FDA has approved a new blood test called Shield to screen for colorectal cancer.[
    • Colonoscopies are still considered the gold standard for detecting and treating colorectal cancer.
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (95%)
    No formal fallacies found. However, there are some informal fallacies and dichotomous depictions present in the article. The author presents the new blood test as an alternative to colonoscopies, which is misleading since it's stated later that colonoscopies are still recommended and more accurate for detecting cancer.
    • Doctors say colonoscopies remain best way to screen for, treat colorectal cancer
    • The FDA APPROVED THAT BLOOD TEST TO SCREEN FOR COLON CANCER
    • The test has been approved for people over age of 45, WITH AN AVERAGE RISK OF COLON CANCER... Health experts said colonoscopies are still considered the gold standard for screening.
    • The new blood test is recommended every three years.
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

97%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

Doctor explains newly authorized blood test for colorectal cancer

WCVB-TV Boston News Division Ed Harding Monday, 29 July 2024 21:04
  • Unique Points
    • The FDA has approved a new blood test for detecting early signs of colorectal cancer.
    • It is not as good at picking up polyps or pre-cancerous growths compared to colonoscopies.
  • Accuracy
    • ]The FDA has approved a new blood test for detecting early signs of colorectal cancer.[
    • The best screening test is the one that gets done.
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (100%)
    None Found At Time Of Publication
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (100%)
    None Found At Time Of Publication

96%

The overall score is a weighted number that takes into account conflict of interest, bias, deception and other practices that undermine the credibility of the source. It is calculated as:
(Site Conflicts Of Interest + Author Conflicts Of Interest) / 2.0 * 0.2 + ArticleBiasScore * 0.20 + UniquePointsScore * 0.05 + DeceptionScore * 0.20 + ReadabilityScore * 0.05 + FallacyScore * 0.20

A score that takes into consideration the content for flow, interruptions with ads, and overt search engine optimization techniques that makes the content hard to understand

Breakthrough Blood Test for Colorectal Cancer Gets Green Light

WebMD Monday, 29 July 2024 23:22
  • Unique Points
    • John Gormly, a 77-year-old business executive in Newport Beach, CA had stage II colon cancer detected through Shield blood test and recovered quickly after tumor removal
  • Accuracy
    • Shield test can accurately detect colorectal cancer about 87% of the time in early stages
    • The simplicity of a blood test could make it more likely for people to be screened for colorectal cancer and ultimately survive the disease
    • Colorectal cancer is a common type of cancer diagnosed and leading cause of cancer deaths in the US
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (95%)
    The article makes several statements that are factual and do not contain any logical fallacies. However, there is an instance of an appeal to authority when the author quotes John Gormly's experience with the Shield test and his subsequent colonoscopy result. This does not detract significantly from the overall accuracy of the article, but it should be noted as a potential source of bias or influence.
    • The FDA on Monday approved the test, called Shield, which can accurately detect tumors in the colon or rectum about 87% of the time when the cancer is in treatable early stages.
    • Shield was shown in trials to have a 10% false positive rate.
  • Bias (100%)
    None Found At Time Of Publication
  • Site Conflicts Of Interest (100%)
    None Found At Time Of Publication
  • Author Conflicts Of Interest (0%)
    None Found At Time Of Publication