Putting High-Risk (HR) HPV to the Test: A New Generation of Testing

Helping to combat cervical cancer with one of the few HR HPV tests approved for use as primary screening.

Nearly everyone who is sexually active will be infected with HPV in their lifetime.

It’s a not-so-fun fact that we may not want to think about, but it’s a real threat to health around the globe.


Some types of HPV can cause cervical cancer, the fourth most commonly occurring cancer in womenAnd it is estimated that 13,960 new cases of invasive cervical cancer will be diagnosed this year in the U.S. alone.

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

In the past, Pap tests, which look at cervical cells to see if there are any changes that might lead to cancer, were the standard to check for cervical cancer.

Today, HPV screening — a form of molecular HPV testing — is helping us as we work to introduce the next generation of diagnostics.

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, not all HR HPV tests are approved to be used alone for primary screening, and most tests don’t provide genetic information on all of those 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.

Why Our Test?

Our Alinity m HR HPV test allows both those seeking care and those providing care to follow the most up-to-date recommendations on the best way to help protect against cervical cancer.

With a streamlined process for laboratories, our test can provide information to HCPs to help potentially save healthcare institutions resources and money — putting HPV to the test and helping women get back to living their fullest, healthiest lives.

*Alinity m HR HPV assay is for In Vitro Diagnostic Use. Rx Only.

This article was originally published on Nov. 2, 2023 and updated on Nov. 7, 2023.