News Releases

hTERC Fluorescence In Situ Hybridization (FISH) Now Offered by CBLPath

CBLPath joins small handful of labs in U.S. able to offer FISH test for cervical cancer

8/13/2014

Rye Brook, N.Y. – CBLPath, a Sonic Healthcare USA laboratory, is pleased to announce that it has received approval from the New York State Department of Health to offer the hTERC assay for cervical cancer. This fluorescence in situ hybridization (FISH)-based assay can be utilized for women with low-grade or atypical Pap test results to determine their risk of developing high-grade lesions.

Despite advances in screening, cervical cancer remains a significant cause of morbidity and mortality in women, accounting for approximately 4,000 deaths and 12,000 new cancer diagnoses in the United States each year. Cervical cancer is caused by human papillomavirus (HPV) infection and arises from pre-cancerous cells that have the potential to progress into cancer with time.

While Pap and HPV screening tests are able to detect the presence of these pre-cancerous cells and the virus that causes them, respectively, both tests have limitations in differentiating aggressive forms of the disease that require surgical intervention from non-aggressive forms. The hTERC test was developed to assist with this shortcoming by analyzing the number of copies of the human telomerase RNA component (hTERC) gene that are present in cervical cytology specimens. Studies have shown that the presence of additional copies of the hTERC gene predicts the presence of or development of high-grade lesions (i.e., CIN2/3 or invasive carcinoma) with high sensitivity and specificity, while the absence of additional copies predicts the absence of high-grade lesions and lack of progression. Thus, women who receive a Pap result such as LSIL or ASC-H may benefit from the hTERC assay’s ability to provide additional risk stratification, thereby aiding in triaging for colposcopy.

"CBLPath is pleased to be one of the few labs based in the United States to offer this critical test to patients," said CBLPath Co-CEO and Chief Medical Officer, Dr. Carlos D. Urmacher, FCAP, FASCP. "Our recent approval from New York State to offer the hTERC FISH assay will enable us to help clinicians quickly identify which patients may progress to aggressive forms of cervical cancer."

To speak with a local CBLPath representative about ordering hTERC testing for cervical cancer, call 877.225.7284. To see the company’s entire array of tests, visit www.CBLPath.com and click the Test Menu link.

About CBLPath

CBLPath, a Sonic Healthcare USA laboratory, is a leading pathology services provider, combining anatomic pathology with advanced molecular diagnostics, esoteric testing and digital pathology. CBLPath is committed to helping our clients deliver better medicine, faster. At our core are pathologists; excited about technology and innovation and its promise of helping patients. We integrate comprehensive diagnostic, prognostic and theranostic testing to deliver personalized medicine and we provide our subspecialty physician clients timely, accurate results enabling the most effective patient care. For more about the company, please visit CBLPath.com.

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