GeneNav HPV Detection Kits

Her first line of defense against cervical cancer

The Human Papilloma Virus, also known as HPV, is the most common sexually transmitted disorder affecting millions worldwide. In fact, at least 4 out of 5 women will have been infected with the HPV virus by age 50. There are over 120 known types of HPV; about 40 of these types infect the epithelial lining of the anogenital tract, mouth, and throat. In the majority of individuals (90%), HPV infections are asymptomatic and usually clear up within 2 years without the need for any medical intervention. However, an infection with any of the 14 High Risk HPV Subtypes can persist and progress into cervical cancer.

Our Solutions

HPV and Cervical Cancer

Cervical cancer is the second most common cancer in women worldwide with an estimated 530,000 new cases and 270,000 deaths each year. Cervical cancer is especially a problem in developing countries that account for over 85% of worldwide deaths. Unlike all other types of cancers, cervical carcinoma has a clearly defined causation — persistent infection with one of the high-risk HPV subtypes. In fact, over 99.7% of all cervical cancer is linked to these HPV infections, with High Risk HPV subtypes, with HPV 16 and HPV 18 alone accounting for over 70% of cervical cancer cases.
HPV 16, HPV 18, HPV 31, HPV 33, HPV 35, HPV 39, HPV 45, HPV 51, HPV 52, HPV 56, HPV 58, HPV 59, HPV 66, and HPV 68
500,000 women are diagnosed with cervical cancer each year
2 million women are at risk for cervical cancer
These 14 HPV subtypes account for over 99% of all cervical cancer cases, with HPV 16 and HPV 18 alone accounting for 70%.
Every year, over 500,000 women are diagnosed with cervical cancer.
In developing countries, over 2 million women aged 15 years and older are at risk for developing cervical cancer.

The Benefits of HPV Testing

The Pap smear (a microscopic examination of cells by a cytotechnician or pathologist) has become a valuable part of women’s healthcare since its introduction in 1940. Though specific, this method produces false negative results about 50% of the time due to its low sensitivity. As a result, medical guidelines in many countries around the world now include HPV DNA testing as part of regular screenings to prevent cervical cancer. In fact, the World Health Organization (WHO) recommends that all women over the age of 30 should undergo routine HPV testing.
Let the Data Speak for Itself:
HPV vs Pap Test Comparison Graph
Left – 4.7% of women who were found to be Pap-positive vs. 7.6% of women who were found to be HPV-positive developed cervical cancer. 0.36% of women who were found to be pap negative vs. 0.17% of women who were found to be HPV-negative developed cervical cancer.
HPV vs Pap Test Comparison Graph
Right – 12.1% of women who were both HPV and Pap-positive, 5.9% of women who were HPV-positive but Pap-negative, 0.86% of women whowere HPV-negative but Pap-positive, and 0.16% of women who were HPV and Pap-negative developed cervical cancer.
Clinical Guidlines for Cervical Cancer Screening

Clinical Guidelines

  • The Pap smear alone is recommended for women aged 21-29 every 3 years
  • A Pap smear and an HPV test (co-testing) is recommended for women aged 30-65 every 5 years
  • Women aged 65 and older may not require cervical screening if:
    • They have no history of moderate or severe abnormal cervical cells or cervical cancer
    • They have had three negative Pap smear results in a row or two negative co-test results in a row within the past 10 years
  • References

    1. Center for Disease Control. Basic Information about HPV and Cancer. CDC, 21 Sept. 2012. Link.
    2. Steben, Marc, and Eliane Duarte-Franco. "Human papillomavirus infection: Epidemiology and pathophysiology." Gynecologic Oncology 107.2 (2007): S2-S5. Link.
    3. World Health Organization. Human papillomavirus (HPV) and cervical cancer. June 2016. Link.
    4. Parkin, Donald M. "The global health burden of infection-associated cancers in the year 2002." International Journal of Cancer 118.12 (2006): 3030-44. Link.
    5. de Sanjose, Silvia, Wim G. Quint, Laia Alemany, Daan T. Geraets, and Jo Ellen Klaustermeier. "Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study." The Lancet Oncology 11.11 (2010): 1048-56. Link.
    6. Cuzick, Jack, Christine Clavel, Karl-Ulrich Petry, Chris J. Meijer, and Heike Hoyer. "Overview of the European and North American studies on HPV testing in primary cervical cancer screening." International Journal of Cancer 119.5 (2006): 1095-101. Link.
    7. Katki, Hormuzd A., Walter K. Kinney, Barbara Fatterman, and Thomas Lorey. "Cervical Cancer Risk for 330,000 Women Undergoing Concurrent HPV Testing and Cervical Cytology in Routine Clinical Practice at a Large Managed Care Organization." The Lancet Oncology 12.7 (2012): 663-72. Link.
    8. "New Guidelines for Cervical Cancer Screening." The American College of Obstetricians and Gynecologists. ACOG, Sept. 2013. Link.
    9. Saslow, Debbie, Diane Solomon, Herschel W. Lawson, Maureen Garcia, and Ann Moriarty. "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 Can." A Cancer Journal for Clinicians 62.3 (2013): 142-72. Link.