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Cervical Cancer, TERC, FISH

Cervical Cancer, TERC, FISH

Test Summary

Cervical Cancer, TERC, FISH

  

Clinical Use

  • Assess risk of progression to high-grade lesions and cervical cancer in women with LSIL

  • Refine cervical cancer risk assessment when Pap test results are ambiguous (ie, ASC-H)

Clinical Background

Cervical cancer is an important disease in women, with more than 12,000 new cases and over 4,000 deaths projected in 2012.1 Progression to cervical cancer begins with the infection of cervical cells by high-risk human papillomavirus (HPV). Although HPV infection usually resolves spontaneously, persistent infection may cause transformation to precancerous lesions that can be detected using cytology (Pap) testing or biopsy.2 Detection of these lesions and subsequent treatment can prevent progression in most cases.3 Thus, current guidelines recommend routine Pap testing starting at age 21. High-risk HPV testing is also recommended in select populations.2,4 Although this strategy is effective at detecting lesions early, it also results in some cases of unnecessary testing and treatment since only 7% to 21% of low-grade lesions progress to high-grade lesions.5

New tests are needed to more accurately predict which precancerous lesions would actually progress to cancer. Tests based on detection of chromosomal changes, which play an important role in progression to cancer, may prove useful. One such test is the Cervical Cancer, TERC, FISH test, which detects amplification of the human telomerase RNA component (TERC) gene and/or polysomy of chromosome 3. TERC gene amplification and chromosome 3 polysomy have been associated with progression of low-grade lesions to high-grade lesions and cancer, while their absence has been associated with lack of progression and even regression.6-8 Thus, test results may help refine the risk of progression in women with LSIL. Women with a positive result have a higher risk of progressing to high-grade lesions and invasive cancer and are more likely to benefit from colposcopy.8,9 Women with a negative result have a lower risk of progression and theoretically could be followed up more conservatively, thereby reducing unnecessary procedures.7,8

TERC gene amplification has also been associated with high-grade lesions on biopsy in patients with an ASC-H Pap test result.6 Thus, these patients may benefit from immediate colposcopy.

Individuals Suitable for Testing

  • Women with LSIL or ASC-H Pap results

Method

  • Dual-color fluorescence in situ hybridization (FISH)

   Probe specific for TERC gene at 3q26 locus and a control probe specific for the chromosome 3

pericentric region

   Cells are scored for amplification (increase in number of copies of TERC relative to control)

   Cells are scored for polysomy (≥3 probe signals for both TERC and control)

  • Results reported as:

   Negative (absence of both amplification and polysomy)

   Amplification (>1% of cells demonstrate amplification)

   Polysomy only (>3% of cells demonstrate chromosome 3 polysomy)

   Percentage of amplified and polysomy cells provided

Reference Range

TERC gene not amplified and polysomy not detected.

Interpretive Information

In women with LSIL cytology, absence of TERC amplification and/or chromosome 3 polysomy suggests a lower likelihood of progression to a high-grade lesion and cancer.

In women with ASC-H cytology, amplification of the TERC gene and/or polysomy of chromosome 3 suggests presence of a high-grade lesion. These women are more likely to benefit from colposcopy.

References

  1. Siegel R, Naishadham D, Jemal A. Cancer Statistics, 2012. CA Cancer J Clin. 2012;62:10-29.

  2. 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 Prevention and Early Detection of Cervical Cancer. CA Cancer J Clin. 2012;62:147-172.

  3. McCredie MRE, Sharples K, Paul C, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol. 2008;9:425-434.

  4. Moyer VA; on behalf of the U.S. Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Mar 14. [Epub ahead of print]

  5. Melnikow J, Nuovo J, Willan AR, et al. Natural history of cervical squamous intraepithelial lesions: a meta-analysis. Obstet Gynecol. 1998;92:727-735.

  6. Andersson S, Sowjanya P, Wangsa D, et al. Detection of genomic amplification of the human telomerase RNA gene TERC, a potential marker for triage of women with HPV-positive, abnormal Pap smears. Am J Pathol. 2009;175:1831-1847.

  7. Jalali GR, Herzog TJ, Dziura B, et al. Amplification of the chromosome 3q26 region shows high negative predictive value for nonmalignant transformation of LSIL cytologic finding. Am J Obstet Gynecol. 2010;202:581.e1-e5.

  8. Heselmeyer-Haddad K, Sommerfeld K, White NM, et al. Genomic amplification of the human telomerase gene (TERC) in Pap smears predicts the development of cervical cancer. Am J Pathol. 2005;166:1229-1238.

  9. Wright TC Jr., Massad LS, Dunton CJ, et al; 2006 ASCCP-Sponsored Consensus Conference. 2006 consensus guidelines for the management of women with abnormal cervical screening tests. J Low Genit Tract Dis. 2007;11:201-222.
     

This test was developed and its performance characteristics determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.
 Content reviewed 12/2012
 

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