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Cervical cancer is the fourth most common cancer in women globally with around 660,000 new cases and 350,000 deaths annually (2022 estimates).

Despite the high prevalence 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. This enables individuals to detect high-risk strains of HPV early, helping to prevent cervical cancer from developing  

It’s All About the Genes

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 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 genotypes (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 healthcare providers make informed decisions about patient care — whether someone tests positive for the three highest-risk HPV genotypes 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 healthcare provider 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 healthcare provider 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 healthcare provider likely may have the sample processed further to identify any cellular changes, and continue monitoring the infection.

Expanding Access to Care with Self-Collection

At ºù«ÍÞÊÓƵ, 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 have a higher strain of HPV that could cause cervical cancer.

ºù«ÍÞÊÓƵ Molecular is proud to announce our new CE-marked HR HPV assay that includes self-collection of vaginal samples using the simpli-COLLECT HPV Collection Kit or the Evalyn Brush. Self-collection at home or in a clinical setting enables women greater flexibility with improved access to care, supporting the fight against cervical cancer.

*Alinity m HR HPV assay is for In Vitro Diagnostic Use. The simpli-COLLECT HPV Collection Kit is CE-marked and not approved for use in the United States. 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.

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This article was originally published on Nov. 2, 2023 and updated on Nov. 7, 2023. The story was updated on April 23, 2025 with new information on our self-collection kit.