Primary HPV testing for cervical cancer screening

  • Most sensitive and efficient screening test1
  • Recommended by the American Cancer Society (ACS)2 and the United States Preventive Services Task Force (USPSTF)3
  • Can test using self-collected samples vs clinician-collected with a speculum
95%+

Nearly all cervical cancers are caused by HPV (Human papillomavirus)4

96%+

Primary HPV testing on a Teal Wand sample is highly sensitive, catching disease 96% of the time. A Pap alone does not test for HPV.

3 Cervical Cancer Screening Tests

There are three tests approved for cervical cancer screening. These tests are good at finding cancer and precancer, but the Primary HPV test is better at preventing cervical cancers and is the more efficient test.6

Primary HPV

Recommended Test
+

Test Sensitivity: Primary HPV testing is highly sensitive, rarely missing cases where HPV-related disease is present.5 In addition, a negative result means a very low risk of HPV-related precancer or cancer developing in the screening interval.

Screening Guidelines: The recommended screening test by the ACS and USPSTF.

Co-test (HPV test + Pap)

+

Test Sensitivity: Highly sensitive because it is performing a Primary HPV test and the Pap test, but it is inefficient to perform two tests on all women and can lead to more unnecessary follow-up tests (12% more colposcopies than Primary HPV test).10

Screening Guidelines: Listed as an alternative to Primary HPV testing because a co-test is less efficient. It is recommended that these dual tests be reserved for the subset of women who have abnormal results.

Pap smear

+

Test Sensitivity: Least sensitive test, compared to HPV testing. The Pap smear is only able to detect cell changes once they have happened - which could be a sign of cancer already being present. A Pap alone does not test for HPV, which causes almost all cervical cancers.

Screening Guidelines: Listed as an alternative to Primary HPV testing, Pap smears must be performed more often (more frequent screening interval) due to lower sensitivity.

“If we were to start cervical cancer screening today, we’d never select a screening test with a sensitivity of 50% if there was an alternative with greater than 90%.

It’s time we allow the Pap test to enjoy a well-deserved retirement.7

Thomas Lorey, MD, pathologist, senior consultant and former director of laboratory services for Kaiser Permanente Northern California

Cervical Cancer Screening: Then and Now

First introduced in the 1940s and called the Pap smear, cervical cancer screening tests have evolved in the last couple of decades, however, the collection method has remained the same, until now.

1940s & 1996

Pap smears started in the 1940’s (50-75% sensitivity12) with liquid based cytology entering in 1996 (+10% sensitivity). Samples were collected with a speculum and brush and evaluated for cell changes.

2003 & 2014

HPV tests started in 2003 (72-90% sensitivity13, 14) and were used as an adjunct to a Pap and then as a co-test. The first Primary HPV test was FDA-approved in 2014 (95%+ sensitivity15). Samples still collected with a speculum and brush.

Now

Primary HPV tests, the recommended test, unlock the ability for women to self-collect their sample without a speculum (>96% relative sensitivity16). The first at-home self-collection device, the Teal Wand, is FDA-approved.

Primary HPV enables at-home self-collection

Primary HPV testing is the most sensitive test for cervical cancer screening and it allows for self-collection, which is crucial for overcoming barriers to screening such as discomfort and access, and increasing screening engagement.

The Teal Wand, now FDA approved, allows a woman to collect a sample for Primary HPV testing, from the comfort and convenience of home.

See How It Works

Self-collect Primary HPV testing around the world

Primary HPV tests are the preferred screening method in many countries, especially well resourced settings.8 In addition, many countries already have self-collection cervical cancer screening programs using Primary HPV testing.

The World Health Organization (WHO), along with all 194 members, have vowed to accelerate the elimination of cervical cancer9 as a public health problem. Some countries are on track to do so within the coming decade, through their ability to reach more women with at-home self-collection.

Eliminate Cervical Cancer in the U.S.

Dive Deeper Into the Research

Medical Research

U.S. Clinical Study Demonstrates At-Home Screening is as Accurate as In-Clinic and Preferred by 94% of Women

Read more
Medical Research

How Stigma Can Stifle Care: Rethinking HPV Risk and Progression of Infection to Cervical Cancer

Read more
Medical Research

How At-Home Self-Collection Can Improve Cervical Cancer Screening Engagement Among the LGBTQ+ Community

Read more

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Sources
LBL-038 Rev.0
LBL-038 Rev.1