Overview
Package Inserts
Leading the charge in cervical disease prevention with the ThinPrep® system and Aptima® HPV assays
Hologic has remained an unwavering advocate for women’s health for more than two decades. Our goals as a company are intrinsically tied to changes in best-practices for women’s health, applying the latest findings in diagnostic medicine to the development of new products and technologies in response to the emergence of new discoveries in medicine.
Cervical disease screening is an essential component of our efforts in women’s health. Hologic is the leader in Pap and human papillomavirus (HPV) testing. The ThinPrep Pap test helps healthcare providers and laboratory professionals detect the presence of abnormal cervical cells, and the Aptima HPV assays identify high-risk HPV mRNA that is indicative of the HPV infections most likely to lead to cervical disease.1-3
Know the Facts
The Pap test has been the most successful cancer screening program in history.4
The rate of cervical cancer, which was a leading cause of death among women, has fallen by more than 70 percent since the Pap test was introduced over 80 years ago.5 Previously, cervical cancer was the leading cause of cancer death in women, but now it is the fifteenth most frequent.
Reducing cervical cancer incidence requires a comprehensive strategy.
Such a strategy will include screening options that take into account disparities that underserved women face. This strategy should focus on reducing preventive screening gaps by:
Implementing provider and patient education
Providing access to vaccinations
Offering Pap + HPV (co-testing)
ACOG, ASCCP, SGO and USPSTF guidelines recommend:
For women ages
21-29 years6
Screening with cervical cytology alone every 3 years is recommended.
For women ages
30-65 years old*6
Co-testing with cervical cytology and high-risk HPV testing every 5 years is recommended.
For women ages
65 years and older6
Do not require screening after adequate prior negative screening results.
The Preferred Choice in Pap Testing
- The ThinPrep Pap test was the first liquid-based cytology option in cervical cancer screening. In more than two decades the ThinPrep Pap test has contributed to a significant decline in cervical cancer rates.1,7
- More than 80% of the Pap Tests in the US are preformed with ThinPrep, with more than 1 billion tests preformed globally so far.8
- 90% of the Top US Best Hospitals for gynecology trust the ThinPrep Pap Test. 8,9
Regardless of the algorithm, the collection method is the same.
The difference is in the results — with HPV-Alone†, you will receive less information with the same collection. Samples may be collected in an FDA approved liquid-based cytology medium, such as ThinPrep® Pap Test.
A comprehensive list of FDA Approvals/Clearances for Ancillary Testing Needs:
-
ThinPrep® Pap Test
-
Aptima® HPV assay
-
Aptima® HPV 16 18/45 genotype assay
-
Aptima Combo 2® assay for CT/NG
-
Aptima® Trichomonas vaginalis assay
- cobas® HPV assay
- cobas® AMPLICOR CT/NG test
- Hybrid Capture 2 HPV DNA Test
- ProbeTec™ CT/GC Qx Amplified DNA assays
Testing out of the ThinPrep vial requires no cumbersome pre-treatment steps for similar workflow.1
About HPV Type 45:
-
It is uncommon and only prevalent in 0.4% of women with normal cytology.10
-
It is the third most common HPV type in invasive cervical cancer.10,11
-
Adenocarcinoma is associated with types 16, 18 and 45.12,13
The Aptima HPV 16 18/45 genotype assay targets these genotypes. These genotypes identify more women at risk with minimal impact to colposcopy rates.10
HPV types 16, 18, and 45 are associated with up to
94%
of HPV-related cervical adenocarcinomas.10
Identify
Identify the presence and activity of high-risk HPV Infection.14,15
Superior specificity
Equivalent sensitivity to DNA based tests, with superior specificity.2,16,17
Next generation
Next generation genotyping.
Aptima® mRNA HPV testing: detects E6/E7 mRNA. The expression of E6/E7 is indicative of the HPV infections most likely to lead to disease.14,15 The Aptima® HPV assay maximizes the benefits of screening while minimizing the potential harm.
Studies have shown that while nearly all unvaccinated sexually active men and women will have HPV at some point in their lives, very few infections will progress to cancer.18
* Aptima HPV assay, Aptima HPV 16 18/45 Genotype assay, Cervista HPV HR test, Cervista HPV 16/18 test, Roche cobas HPV test and Hybrid Capture 2 HPV DNA test.
† A positive HPV screening result may lead to further evaluation with cytology and/or colposcopy.
References:
1. ThinPrep 2000 Processor. US instructions for use MAN-02624-001. Hologic, Inc.; 2021. 2. Aptima HPV assay. US package insert AW-12820-001. San Diego, CA: Hologic, Inc.; 2020. 3. Aptima HPV Genotype 16 18/45 assay. US package insert AW-12821-001. San Diego, CA: Hologic, Inc.; 2020. 4. American Cancer Society. The Pap (Papanicolaou) Test. American Cancer Society website. Last Revised January 3, 2020. Accessed April 28, 2022. https://www.cancer.org/cancer/cervical-cancer/detection-diagnosis-staging/screening-tests/pap-test.html. 5. American Cancer Society. Cancer Statistics Center. Published 2018. Accessed May 13, 2022. https://cancerstatisticscenter.cancer.org/#!/cancer-site/Cervix 6. American College of Obstetricians and Gynecologist. Women’s Health Care Physicians. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines. Released April 2021. Accessed May 3, 2022 7. SEER21 Delay-Adjusted Incidence rate Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER Research Data, 21 Registries, Nov 2019 Sub (1975-2017). 8. Hologic, Inc. Data on file. 9. US News & World Report. Best Hospitals for Adult Gynecology. US News & World Report website. Published 2021. Accessed April 26, 2022. https://health.usnews.com/best-hospitals/rankings/gynecology. 10. de Sanjose S, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056..11. Hopenhayn C, et al. Prevalence of Human Papillomavirus Types in Invasive Cervical Cancers From 7 US Cancer Registries Before Vaccine Introduction. J of Low Genit Tract Dis. 2014;18(3):182-9. 12. Tjalma WA, et al. Differences in human papillomavirus type distribution in high-grade cervical intraepithelial neoplasia and invasive cervical cancer in Europe. Int. J. Cancer. 2013;132(4):854–867. 13. Guan P, et al. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer. Intl. J Cancer. 2012;131(10):2349-2359. 14. Tinelli A, et al. HPV viral activity by mRNA-HPV molecular analysis to screen the transforming infections in precancer cervical lesions. Curr Pharm Biotechnol. 2009;10(8):767-771. 15. Cuschieri K, et al. Human papillomavirus type specific DNA and RNA persistence–implications for cervical disease progression and monitoring. J Med Virol. 2004;73(1):65-70. doi:10.1002/jmv.20062. 16. Iftner T, et al. Head-to-head comparison of the RNA-based Aptima human papillomavirus (HPV) assay and the DNA-based hybrid capture 2 HPV test in a routine screening population of women aged 30 to 60 years in Germany. J Clin Microbiol. 2015;53(8):2509-2516. 17. Cuzick J, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 2013;108:908-913. doi:10.1038bjc.2013.22. 18. CDC. Genital HPV Infection - CDC Fact Sheet. Centers for Disease Control and Prevention website. Published July 2017. Accessed April 28, 2022.https://www.cdc.gov/std/hpv/HPV-FS-July-2017.pdf.
Aptima+ThinPrep Cervical Health Safety Data Sheets
Overview
Package Inserts
Leading the charge in cervical disease prevention with the ThinPrep system and Aptima HPV assays
Hologic has remained an unwavering advocate for women’s health for more than two decades. Our goals as a company are intrinsically tied to changes in best-practices for women’s health, applying the latest findings in diagnostic medicine to the development of new products and technologies in response to the emergence of new discoveries in medicine.
Cervical disease screening is an essential component of our efforts in women’s health. Hologic is the leader in Pap and human papillomavirus (HPV) testing. The ThinPrep Pap test helps healthcare providers detect the presence of abnormal cervical cells, and the Aptima HPV assays identify high-risk HPV mRNA that is indicative of the HPV infections most likely to lead to cervical disease.1-3
Today, screening with Pap+HPV Together (co-testing) provides the best possible protection against cervical cancer for women ages 30-65.4-6 Now, what was once a top cancer among women is up to 93% preventable.7
The introduction of the Pap smear and, later the ThinPrep Pap test, have contributed to a decline in cervical cancer rates of more than 60% since the 1950s.1,8 Since then, HPV has been identified as a cause of cervical cancer, and HPV testing and vaccinations have been developed.9
These medical triumphs have fortified the medical community’s ability to detect and prevent cervical disease and cancer. Today, the combination of data-supported guidelines for cervical cancer screening and the availability of HPV vaccination are key in the fight for women’s health.
Hologic released the first liquid-based cytology option in cervical disease screening in 1996: the ThinPrep Pap test.1 Today, more than 20 years after the release of the ThinPrep Pap test, it remains the preferred choice in Pap testing in the United States.10 ThinPrep Pap tests account for more than 80% of Pap tests performed in the United States, with 650 million tests performed globally so far.10
More than 170 scientific studies involving the ThinPrep Pap test have demonstrated its benefits, including increased disease detection, reduction of equivocal diagnoses, improved specimen adequacy, adjunctive molecular testing and morphology assessment.11
The College of American Pathologists reported increased HSIL (high-grade squamous intraepithelial lesions) and LSIL (low-grade squamous intraepithelial lesions) in labs using LBC versus labs that utilized conventional Pap testing.12 It also showed increased sensitivity for cervical adenocarcinoma over conventional Pap testing.13
The Aptima HPV assay and Aptima HPV 16 18/45 genotype assay target HPV types that pose the largest threat to women.2,3 While other HPV assays target DNA, the Aptima HPV assays target mRNA, which studies show reflects the presence and activity of high-risk HPV infection.2,3 The Aptima HPV assay detects E6/E7 mRNA, which is indicative of those HPV infections more likely to cause cervical disease.2 The Aptima HPV 16 18/45 genotype assay identifies HPV types 16, 18 and 45, which are associated with up to 80% of all invasive cervical cancers worldwide.3,14-15
Screening women with Aptima HPV assays helps providers optimize care for each patient.
The ThinPrep Pap test is just one of several offerings in the ThinPrep system. The ThinPrep processors, imagers and review scopes help improve workflow in laboratories and assist with cytotechnologists’ ability to identify abnormalities. These instruments help complete the ThinPrep system and maximize laboratory efficiency and accuracy in disease detection.
In addition to the ThinPrep Pap test, Hologic remains committed to providing laboratories with innovative and effective cytology solutions for non-gynecological testing needs.
Processors
Imagers and Review Scopes
Combines the power of ThinPrep imaging and manual microscope review in a single desktop system, with slides imaged and ready for review in approximately 90 seconds.
Identifies 22 areas of interest within the ThinPrep Pap test slides with the largest, darkest nuclei for cytotechnologists to examine.
Same trusted algorithm as the ThinPrep image processor, but with a faster camera, expanded label-reading formats and on-demand imaging.
Presents the 22 fields of view to the cytotechnologist for their review.
Combines the power of the review scope with the flexibility of a manual microscope.
Stainers
Now Available Compass Stainer: Adds flexibility to both routine and special staining procedures. Comes programmed with the ThinPrep Stain Protocol for customer convenience.
From Pap and HPV testing to our full range of diagnostic products and cross-divisional innovations like the Genius™ 3D Mammography exam for breast health, Hologic delivers for women. Our promise to offer innovative products to meet the needs of women globally persists throughout all that we do, including in cervical disease screening. Working together, we can achieve the goal of defeating cervical disease.