FDA Approves First Blood Test, Shield, as Primary Screening Option for Colon and Rectal Cancers: A New Convenient Tool to Detect CRC Early

Palo Alto, California United States of America
83% sensitivity in detecting people with colorectal cancers, 88% sensitivity in detecting stage I, II, and III colorectal cancers
Colorectal cancer is second deadliest cancer in US with over 150,000 diagnoses and 53,000 deaths in 2024
CRC is second deadliest cancer in US, FDA approval expected to encourage more people to get screened and potentially save lives
FDA approves Shield blood test as primary screening option for colon and rectal cancers
First blood test to receive FDA approval for CRC primary screening
One in three eligible adults do not get CRC screenings due to accessibility and reluctance towards other methods like colonoscopies and fecal sample tests
Shield test already available at $895 out-of-pocket cost, with FDA approval Medicare and private insurance companies more likely to cover cost
Shield test could appeal to people resistant to other screening methods but not as good at detecting precancerous growths
Shield test looks for cancer signals from DNA shed by tumors in the bloodstream
FDA Approves First Blood Test, Shield, as Primary Screening Option for Colon and Rectal Cancers: A New Convenient Tool to Detect CRC Early

A new blood test for colon and rectal cancers, called Shield, has been approved by the Food and Drug Administration (FDA) as a primary screening option for adults over 45 years old. This is the first blood test to receive such approval from the FDA.

The Shield test, developed by Guardant Health, looks for cancer signals from DNA shed by tumors in the bloodstream. It has an 83% sensitivity in detecting people with colorectal cancers and 88% sensitivity in detecting stage I, II, and III colorectal cancers.

Colorectal cancer (CRC) is the second deadliest cancer in the United States, with over 150,000 expected diagnoses and more than 53,000 deaths in 2024. One in three eligible people do not get CRC screenings due to accessibility and reluctance towards other options like colonoscopies and fecal sample tests.

The less invasive Shield test could appeal to a significant number of people who are resistant to other screening methods. However, it is not as good as colonoscopies or fecal sample tests at detecting precancerous growths.

CRC is the second deadliest cancer in the US, and one in three eligible adults do not get screened for it. The FDA's approval of Guardant Health's Shield test as a primary screening option for CRC marks a significant step forward in making more convenient tools available to detect this disease early and reduce mortality.

The American Cancer Society projects that over 150,000 people will be diagnosed with CRC in 2024, and the disease will be responsible for more than 53,000 deaths. The FDA's approval of Guardant Health's Shield test as a primary screening option for CRC is expected to encourage more people to get screened and potentially save lives.

The Shield test has already been available to doctors at an out-of-pocket cost of $895. With the FDA approval, Medicare and private insurance companies are more likely to cover the cost of the blood test, making it more accessible for patients.


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Confidence

95%

Doubts
  • Are there any potential false positives or false negatives with the Shield test?
  • Is the sensitivity of the Shield test in detecting precancerous growths sufficient?

Sources

98%

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 blood test to screen for colon cancer

NBC News Digital Tuesday, 30 July 2024 20:39
  • Unique Points
    • FDA approved Guardant Health’s blood test, called Shield, to screen for colon cancer on Monday.
    • Shield has previously been available to doctors at an out-of-pocket cost of $895. With the FDA approval, Medicare and private insurance companies are more likely to cover the cost of the blood test.
    • Dr. Arvind Dasari, an associate professor in the department of gastrointestinal and medical oncology at the University of Texas MD Anderson Cancer Center, called the approval a ‘welcome development’.
    • Fewer than 60% of people who are eligible have had their recommended screening, and the biggest problem is that there’s a significant part of the population that’s not getting screened.
    • John Gormly, 77, had avoided colonoscopy screening for years but took the Shield blood test instead. He was diagnosed with stage 2 colon cancer after receiving a positive result and underwent surgery to remove the tumor.
  • Accuracy
    • This is the second blood test to screen for colon cancer; Epigenomics’ Epi proColon was approved in 2016 but rarely used due to concerns about its accuracy and lack of insurance coverage.
    • Fewer than 60% of people who are eligible have had their recommended screening, and the biggest problem is that there's a significant part of the population that's not getting screened.
    • It's most effective in finding later-stage cancers and would need to be given at least every three years, starting at age 45.
    • Some experts believe that this blood test will help catch cases of colon cancer early enough for more effective treatment.
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (95%)
    The article contains an appeal to authority with the quotes from Dr. Arvind Dasari, Dr. Sapna Syngal, and Robert Smith. However, no formal or informal fallacies were found in the author's assertions.
    • Dr. Arvind Dasari called the approval a ‘welcome development.’
    • Dr. Sapna Syngal said if this test increases the number of people getting screened, it’s going to have a huge impact.
    • Robert Smith said a test like this is not complete if it’s positive and you have not had a colonoscopy.
  • 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

99%

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

In a big step for liquid biopsy, FDA approves a blood screening test for colorectal cancer

STAT News Matthew Herper Monday, 29 July 2024 13:36
  • Unique Points
    • The Food and Drug Administration (FDA) approved a blood test called Shield, made by Guardant Health, for detecting colon cancer on Monday.
    • Colon cancer is the second-most diagnosed cancer in the US and the second-leading cause of cancer death.
    • Many people are unwilling to undergo a colonoscopy, which is both an effective way of finding cancer and removing precancerous lesions.
    • Data from the Centers for Disease Control and Prevention indicate that not only do people frequently not get colonoscopies on schedule, but one in five eligible adults is never screened for colon cancer.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (95%)
    The author makes it clear that the blood test is not as good as colonoscopy in detecting precancerous or early stage cancers. However, he also mentions that some experts welcome the test as a way to address the issue of people's unwillingness to undergo colonoscopies. This could be seen as an attempt to present the blood test in a positive light despite its limitations, which is an example of selective reporting and editorializing.
    • But some experts have welcomed it as a way to approach another problem: As effective as colonoscopy is as both a way of finding cancer and removing lesions that could become cancer later on, many people are unwilling to undergo the procedure.
  • 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

100%

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

A new blood test for colon cancer just got approved by the FDA

Quartz News Site Bruce Gil Monday, 29 July 2024 14:45
  • Unique Points
    • The FDA approved a new blood test called Shield by Guardant Health as a primary screening option for colon and rectal cancers for adults over 45.
    • It looks for cancer signals from DNA shed by tumors in the blood stream.
    • CRC is the second deadliest cancer in the US with over 150,000 expected diagnoses and more than 53,000 deaths in 2024.
    • One in three eligible people do not get CRC screenings due to accessibility and reluctance towards other options.
    • The test is less invasive than colonoscopies and fecal sample tests.
  • Accuracy
    No Contradictions at Time Of Publication
  • 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

99%

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 blood test for colorectal cancer screening among average-risk adults in the US

CNN News Site: In-Depth Reporting and Analysis with Some Financial Conflicts and Sensational Language Jacqueline Howard Monday, 29 July 2024 13:41
  • Unique Points
    • The US Food and Drug Administration (FDA) has approved a blood test for colorectal cancer screening among average-risk adults 45 and older.
    • This is the first blood test to be approved by the FDA as a primary screening option for colorectal cancer.
    • Guardant Health announced that this is the first blood screening test for colorectal cancer that meets requirements for Medicare reimbursement.
  • Accuracy
    • The test, called Shield, will join other types of colon and rectal cancer screening methods like colonoscopies and at-home stool tests.
    • For patients with commercial insurance plans, the cost of the test may vary depending on their individual plan coverage.
    • It's most effective in finding later-stage cancers and would need to be given at least every three years, starting at age 45.
  • 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

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 FDA has approved a new blood test for colorectal cancer called Shield, made by Guardant Health.
    • It is easier for patients to get a routine blood test compared to colonoscopies or fecal sample tests.
    • Regular screening can prevent up to 73 percent of colorectal cancer-related deaths in the US, but as many as 25 to 50 percent of people who should be getting screened are not.
    • The hope is that the new blood test will encourage more people to get screened for colorectal cancer, which is the second-most common cause of cancer-related deaths in the US with an estimated 53,000 Americans expected to die from it this year.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (85%)
    The article by Gina Kolata makes several statements that could be considered deceptive or misleading. Firstly, she states 'It requires only a sample of blood and can find cancers when they are early stage and usually curable.' This statement is not entirely accurate as the test has a poor record of finding precancerous growths which are important for preventing cancer. She also states 'The hope is that the blood test, despite its limitation, can encourage more people to be screened for colorectal cancer.' Here she implies that the limitation of the test is not significant and that it's still a good option for screening. However, she fails to mention that other screening tests have a much better record of finding precancerous growths which are crucial for preventing cancer. Lastly, she states 'Regular screening can prevent as many as 73 percent of those deaths.' This statement is true but it's not clear from the article that this statistic applies to the new blood test specifically.
    • It requires only a sample of blood and can find cancers when they are early stage and usually curable.
    • The hope is that the blood test, despite its limitation, can encourage more people to be screened for colorectal cancer.
  • 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