Aptima®+ThinPrep® Cervical Health

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

The path to defeating cervical cancer 

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 cervical health. 

Cervical cancer screening guidelines help mitigate risk 

The American Congress of Obstetricians and Gynecologists (ACOG) delivers guidelines for cervical cancer screening. For women ages 30-65, this means Pap+HPV Together.6 

ACOG recommends:

  • Pap-alone screening for women ages 21-29.6
  • Co-testing for women ages 30-65.6 

At Hologic, we believe in delivering precision testing that helps women live healthier without enduring a disease that is largely preventable with accurate screening.7 Our tests are designed to help providers Be Sure when it comes to screening. The ThinPrep Pap test is the most widely used Pap test in the United States.10 The Aptima HPV assays identify high-risk HPV infections by targeting E6/E7 mRNA.2,3

The ThinPrep Pap test: First in liquid-based cytology 

Hologic released the first FDA-approved, 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 liquid-based cytology versus labs that used conventional Pap testing.12 It also showed increased sensitivity for cervical adenocarcinoma over conventional Pap testing.13

The ThinPrep Pap test is the only liquid-based Pap test FDA approved for use with all current FDA-approved HPV tests.* It is also FDA cleared for chlamydia, gonorrhea and trichomoniasis testing from the same vial.1,14

HPV testing for precision detection and risk stratification 

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.3,15-16 

Screening women with Aptima HPV assays helps providers optimize care for each patient.

The ThinPrep system helps optimize lab workflow

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

  • ThinPrep® 2000 Processor: Scalable solution for compact work environments; the versatile workhorse that started the ThinPrep revolution.
  • ThinPrep® 5000 ProcessorOffers fully automated, small-batch processing and provides operators flexibility along with walkaway time.
  • ThinPrep® 5000 AutoloaderMaximizes laboratory efficiency with fully automated, large-batch processing with automatic slide patient ID etching.

Imagers and Review Scopes 

  • Now Available ThinPrep Integrated Imager®: 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.
  • ThinPrep® Image ProcessorIdentifies 22 areas of interest within the ThinPrep Pap test slides with the largest, darkest nuclei for cytotechnologists to examine.
  • ThinPrep® Imager DuoSame trusted algorithm as the ThinPrep image processor, but with a faster camera, expanded label-reading formats and on-demand imaging.
  • ThinPrep® Review ScopePresents the 22 fields of view to the cytotechnologist for their review.
  • ThinPrep® Review Scope Manual+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.

A multifaceted approach for women’s holistic health 

To learn more about the Aptima + ThinPrep Cervical Health portfolio, visit HealthDxS.com.

* 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.

References: 1. ThinPrep 2000 Processor [instructions for use]. MAN-02624-001, Rev. 005. Marlborough, MA: Hologic, Inc.; 2017.  2. Aptima HPV assay [package insert]. AW-12820-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2015.  3. Aptima HPV Genotype 16 18/45 assay [package insert]. AW-12821-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2015.  4. Blatt AJ, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015;123(5):282-288 [Study included ThinPrep®, SurePath®, Hybrid Capture® 2 assay].  5. Saslow D, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012; 62(3):147-172.  6. The American College of Obstetricians and Gynecologists. Practice Bulletin 168: Screening for cervical cancer. Obstet Gynecol. 2016;128(4):3111-30. doi:10.1097/ AOG.0000000000001708.  7. Centers for Disease Control and Prevention. Cervical Cancer is Preventable. https://www.cdc.gov/vitalsigns/cervical-cancer/index.html. Updated November 5, 2014. Accessed November 29, 2017.  8. National Cancer Institute. SEER Stat Fact Sheets: Cervix Uteri Cancer. http://seer.cancer.gov/statfacts/html/cervix.html. Published 2016. Accessed December 4, 2017.  9. National Institutes of Health. NIH Fact Sheets: Cervical Cancer. http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76. Updated March 29, 2013. Accessed November 29, 2017.  10. Hologic, Inc. Data on File.  11. Hologic, Inc. View Published Data: Direct-to-Vial Studies. https://healthdxs.com/en/view-published-data/. Accessed November 29, 2017.  12. Eversole GM, et al. Practices of participants in the College of American Pathologists interlaboratory comparison program in cervicovaginal cytology, 2006. Arch Pathol Lab Med. 2010;134(3):331-5. doi:10.1043/1543-2165-134.3.331.  13. Adegoke O, et al. Cervical Cancer Trends in the United States: A 35-Year Population-Based Analysis. J Women Health. 2012;21(10):1031-1037.  14. PrepStain System [product insert]. 779-07085-00, Rev. F. Burlington, NC: TriPath Imaging, Inc., 2011.  15. Li N, et al. Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: Variation by geographical region, histological type and year of publication. Int J Cancer. 128:927-935. doi:10.1002/ijc.25396.  16. De Sanjose S, et al. 2010. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet. doi:10.1016/S1470-2045(10)70230-8.

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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

The path to defeating cervical cancer

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.

The ThinPrep Pap test: First in liquid-based cytology

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

HPV testing for precision detection and risk stratification

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 system helps optimize lab workflow

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

  • ThinPrep 2000 ProcessorScalable solution for compact work environments; the versatile workhorse that started the ThinPrep revolution
  • ThinPrep 5000 ProcessorOffers fully automated, small-batch processing and provides operators flexibility, along with walkaway time
  • ThinPrep 5000 AutoloaderMaximizes laboratory efficiency with fully automated, large-batch processing with automatic slide patient ID etching

Imagers and Review Scopes

  • Now Available ThinPrep Integrated Imager®: 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.
  • ThinPrep Image ProcessorIdentifies 22 areas of interest within the ThinPrep Pap test slides with the largest, darkest nuclei for cytotechnologists to examine
  • ThinPrep Integrated ImagerThinPrep imaging and slide review technology in a single device.
  • ThinPrep Review ScopePresents the 22 fields of view to the cytotechnologist for his or her review
  • ThinPrep Review Scope Manual+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.

A multifaceted approach for women’s holistic health

To learn more about the Aptima + ThinPrep Cervical Health portfolio, visit HealthDxS.com.


References: 1. ThinPrep 2000 Processor [instructions for use]. MAN-02624-001, Rev. 005. Marlborough, MA: Hologic, Inc.; 2017.  2. Aptima HPV assay [package insert]. AW-12820-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2015.  3. Aptima HPV Genotype 16 18/45 assay [package insert]. AW-12821-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2015.  4. Blatt AJ, et al. Comparison of cervical cancer screening results among 256,648 women in multiple clinical practices. Cancer Cytopathol. 2015;123(5):282-288 [Study included ThinPrep®, SurePath®, Hybrid Capture® 2 assay].  5. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012; 62(3):147-172.  6. The American College of Obstetricians and Gynecologists. Practice Bulletin 168: Screening for cervical cancer. Obstet Gynecol. 2016;128(4):3111-30. doi:10.1097/ AOG.0000000000001708.  7. Centers for Disease Control and Prevention. Cervical Cancer is Preventable. https://www.cdc.gov/vitalsigns/cervical-cancer/index.html. Updated November 5, 2014. Accessed November 29, 2017.  8. National Cancer Institute. SEER Stat Fact Sheets: Cervix Uteri Cancer. http://seer.cancer.gov/statfacts/html/cervix.html. Published 2016. Accessed December 4, 2017.  9. National Institutes of Health. NIH Fact Sheets: Cervical Cancer.  http://report.nih.gov/nihfactsheets/viewfactsheet.aspx?csid=76. Updated March 29, 2013. Accessed November 29, 2017.  10. Hologic, Inc. Data on File.  11. Hologic, Inc. View Published Data: Direct-to-Vial Studies. https://healthdxs.com/en/view-published-data/. Accessed November 29, 2017.  12. Eversole GM, et al. Practices of participants in the College of American Pathologists interlaboratory comparison program in cervicovaginal cytology, 2006. Arch Pathol Lab Med. 2010;134(3):331-5. doi:10.1043/1543-2165-134.3.331.  13. Adegoke O, et al. Cervical cancer Trends in the United States: A 35-Year Population-Based Analysis. J Women Health. 2012;21(10):1031-1037.  14. Li N, et al. Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: Variation by geographical region, histological type and year of publication. Int J Cancer. 128:927-935. doi:10.1002/ijc.25396.  15. De Sanjose S, et al. 2010. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet. doi:10.1016/S1470-2045(10)70230-8.
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