Putting high-risk (HR) HPV to the test: A new generation of testing

Cervical cancer is the fourth most common cancer in women globally, with approximately 662,301 new cases annually, and the fifth most common cancer in women in the United States, with around 13,000 new cases each year.

Despite the high incidence of cervical cancer worldwide, it is a treatable cancer when detected early and managed effectively by a health care professional.

Previously, the Pap test, also known as cervical cytology, was the gold standard for detecting potential precancerous changes in cervical cells and detecting cervical cancer.

Today, the availability of HPV primary screening — a type of molecular HPV testing — along with new self-collection devices, is expanding access to HPV testing globally and in the United States. This enables individuals to detect high-risk strains of HPV early, helping to prevent cervical cancer from developing.

Different Genotypes

Each type of HPV has a unique genetic signature called a genotype. Knowing which genotype of HPV is causing an infection is critical to assessing the likelihood of the infection leading to cancer, and there are 14 HPV genotypes that are classified as high risk (HR) based on their carcinogenic potential.

Unfortunately, most tests don’t provide genetic information on the 14 cancer-causing strains of HPV.

Our Alinity® m HR HPV test* is approved for use by healthcare providers (HCPs) either alone (Primary screening) or in combination with a Pap test and helps enable HCPs to perform a risk assessment by identifying HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotype groupings (31/ 33/ 52/ 58) and (35/ 39/ 51/ 56/ 59/ 66/ 68).

The primary HR HPV screening process with our Alinity m HR HPV test helps HCPs make informed decisions about patient care — whether someone tests positive for the three highest-risk HPV genotype groupings that have been associated with a higher risk of disease progression or the remaining high-risk HPV genotypes which have a lower risk of disease progression.

If someone tests positive for a high-risk genotype of HPV that has been associated with a higher risk of disease progression, they have an increased risk of developing cervical cancer and their HCP may put them on a fast-track to a management plan. This could lead to a colposcopy, which would analyze the cervix and determine the need for a biopsy.

If someone tests positive for a high-risk genotype of HPV that has been associated with a lower risk of disease progression, their HCP will know that their chances of developing cancer are not as high as if they had tested positive for high-risk genotypes 16, 18, and/or 45. In this situation, the HCP likely may have the sample processed further to identify any cellular changes, and continue monitoring the infection. With more knowledge on patient level of risk, health care professionals can make more informed decisions and also avoid unnecessary colposcopy procedures.

Expanding Access to Care with Self-Collection

At Abbott, we believe when testing can be made more accessible, it should be. Expanding the access and comfort of HPV screenings will help more women identify whether they test positive for one of the higher risk HPV genotypes that could cause cervical cancer.

Abbott’s HR HPV test is now approved for use with self-collected samples using either Abbott’s simpli-COLLECT HPV collection kit or the Rovers Evalyn Brush, in both the US and CE-marked countries.

Self-collection kits help empower women to take control of their cervical cancer screenings and provide access to women who may have otherwise avoided the speculum exam or not had access to a clinic to perform the exam. Giving women the ability to comfortably self-collect vaginal samples can help expand access to HPV testing in underserved communities, while also identifying individuals with a higher strain of HPV that could cause cervical cancer.

National and regional reference laboratories and institutions, using Abbott’s Alinity m instruments will be able to offer this self-collection option to their patients. In CE-marked countries, individuals can use the self-collection kit both in a healthcare setting and from the comfort of their own home.

Having self-collection kits in the U.S. is important to help expand cervical cancer screenings to people who may not regularly attend doctor’s appointments. To help with this effort, Abbott will join the National Cancer Institute Cervical Cancer 'Last Mile' Initiative to generate evidence on self-collection approaches to increase screening access.

This collaboration focuses on expanding access to HPV testing for individuals who face barriers to traditional healthcare services. Abbott will provide its self-collection kits as part of the initiative’s ongoing research.

*Alinity m HR HPV assay and the simpli-COLLECT HPV Collection Kit is for In Vitro Diagnostic Use. Rx Only. The simpli-COLLECT HPV Collection Kit has been FDA approved in the U.S. for use in a healthcare setting. The collection kit also has a CE mark for use in a healthcare setting and at home. The intended users for Alinity m HR HPV assay are laboratory professionals. The intended users for the simpli-COLLECT HPV Collection Kit are patients, and laboratory and healthcare professionals.

For more information visit: Alinity m HR HPV Assay (https://www.molecular.abbott/us/en/alinity-m-hr-hpv-assay)
Alinity m HR HPV Assay (https://www.molecular.abbott/int/en/products/infectious-disease/alinity-m-hr-hpv-assay)

This article was originally published on Nov. 2, 2023 and updated on Nov. 7, 2023. The story was updated on April 23, 2025 and again on Dec 08, 2025 with new information on our expanded claim for self-collection in the U.S