FDA Approves Self-Collection for Cervical Cancer Screening: Expanding Access and Convenience with HPV Tests by Roche and BD

United States of America
FDA approves self-collection for cervical cancer screening in a healthcare setting
HPV is the primary cause of cervical cancer and screening should begin at age 25
Roche and BD's HPV tests are now FDA-approved for use with self-collected samples
Self-collection could potentially lead to home testing in the future
Self-collection involves patients using a kit to take vaginal samples for HPV testing
FDA Approves Self-Collection for Cervical Cancer Screening: Expanding Access and Convenience with HPV Tests by Roche and BD

FDA Approves Self-Collection for Cervical Cancer Screening: Expanding Access and Convenience

May 15, 2024

The Food and Drug Administration (FDA) has recently approved self-collection for cervical cancer screening in a health-care setting. This decision is expected to expand access to this crucial preventative measure, providing women and people with a cervix a more convenient option for testing.

Self-collection involves patients using a kit to take vaginal samples for HPV testing. HPV, or human papillomavirus, is the primary cause of cervical cancer. The American Cancer Society applauds this decision as it will reduce barriers and increase opportunities for early detection and treatment.

According to the US Preventive Services Task Force (USPSTF), cervical cancer screening should begin at age 25 for women and people with a cervix. The recommended methods include primary HPV testing every 5 years, co-testing every 5 years, or Pap test alone every 3 years.

The FDA's approval of self-collection is significant as it could potentially lead to home testing for cervical cancer in the future. This move comes after the FDA granted 'breakthrough device' status to Teal Health's home cervical cancer screening device, the Teal Wand.

Both Roche and BD have announced that their respective HPV tests, cobas HPV test by Roche and BD Onclarity HPV Assay by Becton, Dickson and Company (BD), are now FDA-approved for use with self-collected samples. This means patients will no longer need to undergo invasive pelvic exams for cervical cancer screening.

Cervical cancer is the fourth most common form of cancer among women globally, and in the US, more than 11,000 cases are diagnosed each year. About half of these diagnoses occur in people who have never been screened or not had a Pap test within the previous five years.

Self-collection has the potential to diversify gynecology care by reducing barriers for marginalized communities and increasing access to screening for those who cannot regularly access gynecologic care. The HPV vaccine, which protects against cervical cancer and genital warts, is recommended since 2006 but does not eliminate the need for regular screening tests.

For more information on American Cancer Society guidelines on cervical cancer screening, visit their website.


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(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 self-collection screening for virus that causes cervical cancer

The Fixing Site: A Summary of the Article. David Ovalle, Wednesday, 15 May 2024 11:00
  • Unique Points
    • The Food and Drug Administration (FDA) approved self-collection screening for cervical cancer
    • Women can now gather samples for testing in private rooms in primary-care doctors’ offices, urgent-care clinics, and pharmacies
    • This move could lead to home testing for cervical cancer
  • 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 greenlights self-collection of vaginal samples for cervical cancer screening

CNN News Site: In-Depth Reporting and Analysis with Some Financial Conflicts and Sensational Language Jacqueline Howard Wednesday, 15 May 2024 21:19
  • Unique Points
    • The US Food and Drug Administration (FDA) has approved the use of self-collected vaginal samples for HPV testing by Roche and BD.
    • Most cervical cancers are caused by human papillomavirus (HPV), and screening for HPV can help identify women who may be at risk of developing cervical cancer.
    • The US Preventive Services Task Force recommends screening for cervical cancer with cervical cytoology every three years for women ages 21 to 29, and for women ages 30 to 65, it recommends screening every three years with cytology alone, every five years with high-risk HPV testing alone or every five years with high-risk HPV testing combined with cytology.
    • BD Onclarity HPV Assay is now FDA-approved for HPV testing on self-collected samples without the need for a traditional Pap test.
    • Roche's cobas HPV test has also been approved for use with self-collection.
    • Each year in the US, more than 11,000 cases of cervical cancer are diagnosed and about 4,000 women die from the disease.
    • About half of invasive cervical cancer cases are diagnosed in people who have never been screened and about 10% of diagnoses are in people who have not had a Pap test in the five years prior.
    • The FDA has granted 'breakthrough device' status to Teal Health's home cervical cancer screening device, the Teal Wand, which could lead to faster approval for at-home self-collection.
  • Accuracy
    No Contradictions at Time Of Publication
  • Deception (100%)
    None Found At Time Of Publication
  • Fallacies (95%)
    The article contains some instances of appeals to authority and dichotomous depictions, but overall the author's assertions are generally accurate and free of logical fallacies. The author quotes several experts in the field of cervical cancer screening and their opinions on self-collection, which is a valid use of an appeal to authority. However, it is important to note that this does not mean that their opinions are infallible or beyond criticism. The author also makes some dichotomous depictions by contrasting traditional pelvic exams with self-collected samples and describing the benefits of each in a simplified manner. This can give readers a false sense of an either/or situation, but it does not necessarily lead to any major logical fallacies. The author's assertions about the FDA's approval of self-collected samples for HPV testing and the benefits of self-collection are generally accurate, as supported by the evidence provided in the article.
    • ]The US Food and Drug Administration has given the go-ahead for patients to have the option to collect their own vaginal samples for screening in a health care setting[.
  • 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

American Cancer Society Statement: FDA Approval of HPV Self-Collection for Cervical Cancer Screening

American Cancer Society Pressroom Thursday, 16 May 2024 00:16
  • Unique Points
    • FDA approves HPV self-collection for cervical cancer screening in a health-care setting
    • American Cancer Society applauds FDA’s decision as it expands access to screening and provides a more convenient option
    • Self-collection involves patients using a kit to take vaginal samples for HPV testing
  • 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 (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

FDA approves self-tests for cervical cancer, as an alternative to the dreaded pelvic exam

USA Today Wednesday, 15 May 2024 00:00
  • Unique Points
    • The FDA has approved new self-tests for cervical cancer screening, allowing patients to swab themselves at the doctor’s office.
    • These tests bypass the need for invasive pelvic exams and aim to reach women who have not been screened regularly.
    • BD and Roche are the makers of these new tests, with plans for eventual at-home options.
    • Results will be provided by clinicians who may advise further testing if abnormal.
    • Both tests report on 14 strains of HPV and could eventually eliminate cervical cancer in the US.
    • Cervical cancer is the fourth most common form of cancer among women globally, with most new cases in the US occurring among those not screened in the previous five years.
    • Self-screening could expand access to care for people at higher risk or those who cannot regularly access gynecologic care.
    • The HPV vaccine, recommended since 2006, protects against cervical cancer and genital warts but does not eliminate the need for regular screening tests.
    • Self-screening has the potential to diversify gynecology care by reducing barriers for marginalized communities.
  • Accuracy
    • Women can now gather samples for testing in private rooms in primary-care doctors offices, urgent-care clinics, and pharmacies
    • Self-collection involves patients using a kit to take vaginal samples for HPV testing
  • 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 (0%)
    None Found At Time Of Publication