High-risk human papillomavirus (HPV) strains are a significant cause of several cancers, including cervical, anal, oropharyngeal (throat), vulvar, vaginal, and penile cancers. Persistent infection with these high-risk HPV types can lead to cellular changes that, if left unchecked, may progress to malignancy. Notably, HPV is responsible for the vast majority of cervical cancers, highlighting its critical role in women's health.



While many HPV infections are transient, the risk of cancer development underscores the importance of prevention through vaccination and early detection via screening. These measures are crucial in mitigating the burden of HPV-associated cancers and improving patient outcomes.



While HPV infections are ubiquitous and often transient, the specter of cervical cancer looms large, making targeted detection of high-risk strains paramount. Though the mere presence of HPV doesn't equate to cancer, persistent infection with oncogenic genotypes—particularly 16 and 18, among others—fuels cellular transformation by disrupting critical cell cycle regulators like p53 and retinoblastoma proteins through the insidious E6 and E7 oncoproteins. Given that HPV is the undisputed etiological agent in over 99% of cervical cancers, a leading cause of female cancer worldwide, focusing on these high-risk viral elements is not just prudent, but essential. By identifying those women harboring persistent, high-risk HPV infections, we can intervene before cellular chaos escalates into malignancy, drastically reducing the burden of this devastating disease.





Alinity m High Risk (HR) HPV assay from Abbott Laboratories is approved by FDA for use as a primary screen for Cervical Cancer. Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA in cervical specimens collected by a health care professional. This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and (35/39/51/56/59/66/68). Alinity m HR HPV is indicated for use in routine cervical cancer screening as per professional medical guidelines to assess the risk of cervical pre-cancer and cancer in women. Abbott's Alinity m HR HPV assay provides automated, high-throughput detection of 14 high-risk HPV genotypes through real-time PCR. Utilizing cervical specimens collected in ThinPrep or SurePath media, the Alinity m System automates all assay steps—from sample preparation to result reporting—offering a streamlined, random-access workflow that enables simultaneous processing of multiple assays on a single platform, ensuring rapid and efficient HPV screening.



Hologic Inc has advanced cervical cancer screening with its Aptima HPV assays, offering both comprehensive high-risk HPV detection and targeted genotyping. The Aptima HPV 16 18/45 Genotype Assay specifically identifies HPV types 16, 18, and 45, which are critically linked to up to 94% of HPV-related cervical adenocarcinomas, a particularly aggressive form of the disease. While type 45 has a lower overall prevalence, it's a significant contributor to invasive cervical cancer. Complementing this, the Aptima HPV assay provides broader screening, detecting E6/E7 mRNA from 14 high-risk HPV genotypes, including the aforementioned 16, 18, and 45, as well as 11 others. This dual approach—targeted genotyping and comprehensive screening—enables clinicians to more effectively identify women at increased risk, facilitating timely intervention and improved patient outcomes.



Hologic's Aptima HPV assay employs mRNA target capture and amplification process. Utilizing magnetic microparticles and oligomers, the assay isolates HPV mRNA, which is then amplified through Transcription-Mediated Amplification (TMA), leveraging reverse transcriptase and RNA polymerase to generate abundant RNA amplicons. Detection is achieved via Hybridization Protection Assay (HPA), using chemiluminescent-labeled probes that bind to the amplicon. These steps are efficiently executed on Hologic's DTS®, TIGRIS® DTS™, or PANTHER® platforms, offering varying degrees of automation from semi-automated to fully automated processing, streamlining HPV screening workflows.

As technology continues to evolve, the future of HPV screening lies in the power of molecular precision. PCR and targeted genotyping represent a pivotal shift from generalized detection to individualized risk assessment, paving the way for more effective prevention and treatment strategies.