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HPV Testing

HPV HIGH-RISK SCREENING PANEL

The new Trovagene HPV High Risk test represents a novel approach to the identification of high-risk HPV patients. It is a urine-based test that delivers an accurate and sensitive assay of 15 high-risk subtypes with the convenience of a urine sample.

HPV GENOTYPES TESTED: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 68 & 70

Sensitivity 93.0%, specificity 96.0%¹

Trovagene Addresses the “HPV Testing Gap"

According to the Centers for Disease Control and Prevention (CDC), approximately 20 million Americans are infected with HPV. New cases appear at the rate of 6.2 million per year.

Eighty percent of women will acquire sexually transmitted HPV by age 50. Nonetheless, only 20% to 40% of women are currently being screened for HPV using DNA tests in conjunction with a standard Pap smear.

In 2012, the US Preventative Task Force (USPTF) approved the HPV test as a mandatory part of the cervical cancer screening guidelines. The trend toward greater use of HPV testing also continues to grow as data accumulate showing that awareness of infection – as well as the type of infection – is important in preventing continued spread of the disease.

The Trovagene HPV High Risk test can address key barriers to universal screening: cost, convenience, and personal or cultural resistance to traditional testing methods.

HPV GENOTYPES

There are more than 100 human papillomavirus genotypes. These types can be classified as high-risk, intermediate risk, and low-risk types, depending on the likelihood that infection may progress to cause cervical cancer.

Current ASCCP guidelines recommend HPV genotyping to help identify women at risk and optimize treatment strategies. Identification of HPV Type 16 and 18, for example, provides grounds for immediate colposcopy.

THE SCIENCE BEHIND THE TEST

Existing HPV tests are based on the analysis of DNA or RNA isolated from cervical cells that must be collected by a trained professional during an office visit. While the importance of HPV testing is increasingly recognized, there are personal and cultural barriers to current testing methods.

Recognizing these realities, Trovagene scientists have identified and patented specific sequences in the HPV E1 region that allow a single PCR reaction to discriminate between High-Risk Types and Low-Risk Types using a simple urine sample. High-Risk Types generate a size-specific amplicon, while low-risk types do not.

Trovagene’s proprietary PCR-based test delivers easy-to-interpret results with high sensitivity and specificity, as shown in an independent clinical study. These E1 DNA sequences allow for a high sensitivity molecular assay that can be performed with the convenience, comfort and flexibility of urine-based testing.

CLINICAL SUPPORT FOR URINE-BASED TESTING

In a recent study,¹ the Trovagene urine-based HPV test was compared with the QIAGEN hc2 High-Risk cervical cell DNA test. Using DNA sequencing as the gold standard, the false negative rate for the urine-based test was 5.6% compared with 16.8% for the hc2 assay; the false positive rate for the urine-based test was 5.0% compared with 17.6% for the hc2 assay. The authors concluded that urine can be used to detect high-risk HPV as opposed to cervical scraping, and that the sensitivity of urine-HPV testing is comparable to currently used QIAGEN hc2 test based on analysis of cervical cells.

REGULATORY INFORMATION

This is a laboratory developed test (LDT). It has not been cleared or approved by the FDA which has determined that clearance or approval is not necessary. This test is used for clinical purposes and should not be regarded as investigational or for research use.

Trovagene's laboratory is certified by the State of California
LICENSE CLF 00338242 in compliance with CLIA (Clinical Laboratory Improvement Amendments) LICENSE 05D1094618, and is accredited by the College of American Pathologists LICENSE LAP 7190902.

INDICATIONS

Testing for carcinogenic or high-risk human papillomavirus (HPV) DNA has proven utility in cervical cancer screening and in many aspects of clinical management for cervical cancer prevention.⁵

High-risk (oncogenic) HPV DNA testing is appropriate in the following circumstances:

Routine cervical cancer screening in conjunction with cervical cytology (dual testing or co-testing) for women 30 years and older:
- For women who are cytology-negative but HPV positive, repeat both tests in 12 months
- For women who are both cytology and HPV negative, repeat both tests only after a 3-year interval
Initial triage management of women 21 and older with a cytologic result of ASC-US
Initial triage management of post-menopausal women with cytologic result of LSIL
Post-colposcopy management of women of any age with initial cytologic result of Atypical Glandular Cells*(AGC) or ASC-H (when initial workup does not identify a high grade lesion)
Post-colposcopy management of women 21 and older with initial cytologic results of ASC-US or LSIL (when initial colposcopy does not identify a high grade lesion)
Post-treatment surveillance.
High-risk (oncogenic) HPV DNA testing is generally NOT appropriate in the following situations:
Routine cervical cancer screening in women less than 30 years of age
Routine screening with HPV testing and cervical cytology more often than every 3 years for women 30 years and older whose tests were negative at last screen
Initial triage or management of adolescents (age 20 and younger) with any abnormal cytologic result. Further, if HPV testing is inadvertently performed, the results should not be used to influence patient management
Initial triage of LSIL (except for post-menopausal women)
Initial triage of ASC-H, HSIL or AGC*/AIS in women of any age
Repeat high-risk (oncogenic) HPV DNA testing should generally not be done in less than 12 months.
Exceptions include follow-up to AGC NOS when no pathology is found at initial workup, and follow-up after treatment for CIN 2,3. See ASCCP Guidelines for specific recommendations on testing intervals.⁶

SAMPLE COLLECTION

Testing requires a 50-100ml urine sample.

Collection kits are provided on request. To order a kit please click here or call client services at 888-391-7992

REFERENCES

Robbins D, Garg D, Li J, Melkonyan H. Detection of high-risk HPV in urine of high- and low-risk populations in India. J Clin Oncol. 2009;27(15s):suppl; abstr 5581.
Meijer CJ, Snijders PJ, Castle PE. Clinical utility of HPV genotyping. Gynecol Oncol. 2006;103:12-17.
American Society for Colposcopy and Cervical Pathology (ASCCP): Consensus guidelines. http://www.asccp.org/ ConsensusGuidelines/HPVGenotypingClinicalUpdate/tabid/5963/Default.aspx
American Society for Colposcopy and Cervical Pathology. Use of HPV genotyping to manage HPV HR positive /cytology negative. Women 30 years and older. http://www.asccp.org/Portals/9/docs/pdfs/Consensus%20Guidelines/hpv_genotyping_20090320.pdf
Wright, Massad, Dunton, Spitzer, Wilkinson, Solomon for the 2006 ASCCP-Sponsored Consensus Conference, 2006 Consensus Guidelines for the Management of Women with Abnormal Cervical Screening Tests. Journal of Lower Genital Tract Disease. 2007;11(4):201–222. and American Journal of Obstetrics and Gynecology 2007;197(4);346-355.
Statement on HPV DNA Test Utilization, Cytopathology Education and Technology Consortium, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2748808/

Ordering Information ►

Contact Client Services

☎ 888-391-7992 (TOLL-FREE)

✉ service@trovagene.com

Benefits

Non-invasive
Patient-friendly
Easy to use
Results typically available within one week
Simplifies patient screening and monitoring
Offers new flexibility in HPV testing and patient management

Clinical Experience Offer

If you have received a CLINICAL EXPERIENCE OFFER CODE from Trovagene, click here to order testing kits.

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Request pick up and shipment to: TROVAGENE INC., 11055 FLINTKOTE AVENUE, SAN DIEGO, CA 92121

Supporting Scientific Data

ASCO Abstract: Detection of High Risk HPV in Urine of High and Low Risk Populations in India

In this study we investigate the feasibility of a urine-based HPV DNA test. We test an HPV genome region in which the sequence appears to distinguish High Risk types, potentially eliminating the need for manufacturing and operating a multiplexed assay.

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FAQ

How is Trovagene's testing different to that offered by other companies?

The Trovagene HPV High Risk test offers a simple and accurate test for high-risk HPV while eliminating many of the barriers to testing. It is a urine-based molecular test that can be administered without a physical exam – even without an office visit. Because it is convenient and non-invasive, it supports comprehensive patient monitoring and the inclusion of women who are uncomfortable with a physical exam. In addition, quick turnaround of results allows for a rapid diagnosis and prompt treatment – reducing patient risk and anxiety.

How prevalent is HPV?

Approximately 20 million Americans carry HPV, with six million new cases occurring every year, according to the Centers for Disease Control and Prevention. By the age of 50, 80 percent of all women will have had exposure to HPV at some point in their lives.

What testing is recommended for HPV?

In 2012, the US Preventative Task Force recommended HPV DNA testing as a mandatory part of the cervical cancer screening guidelines to help diagnose a greater number of women and thereby reduce the risk of developing cervical cancer. Currently, less than 40 percent of women undergo HPV DNA testing in conjunction with a standard Pap smear or liquid cytology sample.

What are the benefits of non-invasive testing?

The Trovagene HPV-HR DNA test is a non-invasive option that may improve the adoption and acceptance rate of HPV testing. Carrier testing for HPV can help raise awareness and encourage use of preventative measures to reduce transmission of the virus. For women who wish to avoid repeated physical exams, but still need monitoring for their HPV status, a urine-based HPV-HR DNA test can facilitate more comprehensive patient monitoring.

“The launch of our urine-based HPV-HR DNA test represents an important milestone for Trovagene,” said Antonius Schuh, Ph.D., chief executive officer. “Non-invasive carrier testing may help to increase awareness of HPV status and could reduce the incidence of HPV-related cervical cancer and other cancers worldwide.”