ALINITY M HR HPV ASSAY
SMARTER CERVICAL CANCER SCREENING STARTS HERE— GENOTYPING, ACCESS, AND ASSURANCE IN ONE
For in vitro diagnostic use. Rx only.
Extended Genotype reporting
- Delivers integrated evidence-based risk stratification for cervical cancer screening by separately reporting 16, 18, 45 and two other HR HPV genotype pools in one reaction
Future Proof
assay Design
- FDA approved for primary screening, co-testing with cytology and ASC-US Triage
- Addresses evolving needs of clinicians and labs
Supporting access
to underserved populations
- Clinically validated for use with self-collected vaginal samples, using our simpli-COLLECT HPV Collection kit and the Evalyn® Brush—expanding women’s access to care
Confidence in Results
- Cellular controls help ensure sample adequacy for accurate and reliable reporting of HPV test results
HPV Genotypes
Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. HPV is the name of a group of 200 known viruses. They do not cause concerns in most people, but a persistent infection with some high-risk (HR) types can cause cancer. More than 95% of the invasive cervical cancers found are associated with 14 HR HPV genotypes.
HPV GENOTYPES 16, 18 AND 45 CONSTITUTE OVER 76% OF INVASIVE CERVICAL CANCER.
Alinity m HR HPV assay individually stratifies 16, 18, 45 and two other HR HPV genotype pools in one reaction so you can make the best clinical decision for your patients.
The ASCCP consensus guidelines for management of cervical cancer screening abnormalities conclude that human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.
DOES YOUR HPV TEST OFFER EXTENDED GENOTYPING?
Read the multi-center study to learn how the Alinity m HR HPV assay with extended genotyping can provide additional information to triage patients for appropriate testing and follow-up and can help minimize unnecessary colposcopies.
HPV Clinical Guidelines
American Society for Colposcopy and Cervical Pathology (ASCCP), US Preventive Services Task Force (USPSTF), and American Cancer Society (ACS) now recommend primary HPV screening as the preferred method for cervical cancer detection.
Advantages of primary HPV screening
- Improved sensitivity for CIN3+ over cytology alone
- Minimize unnecessary colposcopies
- More efficient than co-testing
- Potential for self-collection
- Improve access
Not all HPV tests are the same: Only three tests are FDA approved for primary HPV screening in the United States. Are your current HPV screening practices aligned with the latest clinical guidelines?
LEARN MORE ABOUT ALINITY M HR HPV ASSAY
HPV Clinical Guidelines
Confidence in Results
The Cellular Control (CC) feature plays a critical role in this assuring that the sample is biologically adequate and that the test process worked as intended.
The CC targets an endogenous human DNA sequence, serving as a sample validity control. It confirms:
- Sample adequacy
Ensures the specimen contains sufficient human cellular material. - False negative prevention
Helps rule out false negatives due to insufficient target cells. - Extraction efficiency
Verifies that nucleic acids were successfully isolated. - Amplification integrity
Confirms that PCR amplification occurred without inhibition.
Clinical implications
Cellular Control (CC) can help:
- Reduce oversampling in HPV testing
Particularly beneficial in screening programs where sample adequacy is a concern. - Improve early detection of high-risk HPV types
False negatives may miss infections with high-risk genotypes (e.g., HPV 16 and 18), which are strongly associated with cervical cancer. - Enhance patient safety and outcomes
A false negative can delay diagnosis and treatment, allowing precancerous lesions to progress. Preventing such errors ensures patients receive timely and appropriate care.
What safeguards are in place to ensure your HPV test results are clinically actionable?
LEARN MORE ABOUT ALINITY M HR HPV ASSAY
Expanding Access and Improving Patient Outcomes
ASCCP and USPSTF now include self-collected vaginal samples for HPV testing as a pivotal enhancement in the fight against cervical cancer.
U.S. Preventive Service Task Force
In Dec 2024, the U.S. Preventive Service Task Force (USPSTF) released a draft update to its cervical cancer screening recommendations, which, for the first-time, included self-collected HPV samples as an acceptable option when collected in clinical settings.
American Society for Colposcopy and Cervical Pathology (ASCCP)
In February 2025, under the Enduring Guidelines framework, the American Society for Colposcopy and Cervical Pathology (ASCCP) released the first major clinical guidance supporting the use of self-collected vaginal samples for HPV testing. This ensures the practice is evidence-based, broadly endorsed, and aligned with risk-based management principles.
“Self-collection helps expand access to potentially life-saving screening to patients who would prefer not to have a speculum exam or whose primary care physicians don’t conduct pelvic exams.”
– DR. REBECCA PERKINS, CO-CHAIR AT ASCCP
Can self-collected samples help you reach more women in your practice?
Alinity m HR HPV Assay has flexible sample collection
VAGINAL SPECIMENS
- Self-collected in a clinical setting with zero physician assistance
- simpli-COLLECT™ HPV Collection Kit or Evalyn® Brush
CERVICAL SPECIMENS
- ThinPrep® or SurePath™
Explore
Alinity m HR HPV Assay
Be ready to ready to meet evolving testing needs by automating your HR HPV workflow.
Alinity mp
See how this pre-analytical system can help you automate tedious tasks for your HPV workflow.
Alinity m
Learn more about the Alinity m analyzer and how it can help transform your molecular lab
to achieve measurably better
healthcare performance.
REFERENCES
- Alinity m HR HPV Package Insert 53-608175/R02.
- de Sanjose S, Serrano B, Tous S, et al. Burden of Human Papillomavirus (HPV)- Related Cancers Attributable to HPVs 6/11/16/18/31/33/45/52 and 58. JNCI Cancer Spectr. 2019 Jan 7;2(4):pky045.
- simpli-COLLECT™ HPV Collection Kit Package Insert 53-608547/R1.