By OMAR FORD
Medical Device Daily Staff Writer
A test developed by Quest Diagnostics (Madison, Wisconsin) could give greater insight into the likelihood of female patients developing cervical cancer. Late last week the company reported the availability of a the test, which is designed to help physicians identify women who are at increased risk of developing malignancy, unless treated, after receiving unclear results for cervical cancer risk from standard screening tests.
The Quest Diagnostics Cervical Cancer TERC test is based on the human telomerase RNA component (TERC) gene marker under a nonexclusive patent license from the National Institutes of Health (NIH).
Research by NIH has shown that the TERC gene is amplified, indicated by an abnormal number of copies of the gene on chromosome arm 3q, in the precursor cells of cervical cancer and therefore may be useful for risk stratification in Papanicolaou (Pap) screening.
"I think this test is really important because it is sort of the beginning of the third part of this trifecta for testing for cervical cancer. First there was the cytology, then the HPV testing and now the precursor of the tumor's abnormality." Daniel Jones, MD, PhD, medical director, Cancer Diagnostics Services, Quest Diagnostics, told Medical Device Daily. "This test is really the first in that category."
Jones added "the test is important to help define atypical lesions that are found on a pap where further knowledge is needed to help with a follow up. It really represents a first in class to allow us to continue to understand what are the molecular changes in these tumors that are reported. This will help us to do a better job and not just say in cytology that we see something atypical or some abnormal cells that we think are precancerous, but it will really help understand what stage in the cancer process these cells are in."
In the U.S., women are screened for cervical cancer using Pap and/or human papillomavirus (HPV) tests. Neither Pap nor HPV tests provide definitive results for risk for cervical cancer. Pap tests identify and categorize cellular changes according to risk they will become malignant. HPV tests identify infection with HPV, a virus that causes cervical cancer in some women but is cleared by the immune system in others.
The new Quest test is designed as an adjunct to conventional Pap and HPV tests, and is performed on residual samples from Pap tests. It detects abnormal changes to the TERC gene and chromosome three to provide a risk assessment of progression to cervical cancer in women who receive indeterminate Pap and/or HPV test results. TERC results help categorize risk in abnormal Pap tests prior to colposcopy, a procedure to visually inspect cellular changes. Women with the highest risk result may benefit from additional cervical biopsies at colposcopy and more aggressive monitoring and treatment, while women with low-risk TERC and HPV results may be less likely to undergo unnecessary follow-up colposcopy and other procedures.
The new test may be particularly helpful in evaluating women whose Pap test shows mild cellular abnormalities known as low-grade squamous intraepithelial lesions (LSIL). Up to 1.5 million women in the U.S. receive an LSIL result each year. LSIL diagnosis and treatment is associated with higher patient anxiety, morbidity and cost, although many cases never progress to cancer.
Quest said that because cervical cancer may not produce symptoms until advanced stages of disease, screening is vital to detect pre-cervical cellular abnormalities. Guidelines issued in 2012 from the American Cancer Society (ACS; Atlanta) recommend that women of normal risk be screened for cervical cancer with a Pap test every three years between ages 21 and 29, and with a Pap and HPV test together every five years between ages 30 and 65. In the past, the ACS and other organizations recommended Pap screening as frequently as every year for normal-risk adult women depending on type of Pap test, age and other factors.
"Cervical cancer used to be a major cause of death in women in the United States, but thanks to screening, physicians can often catch and treat abnormalities before they progress to cancer," Jones said. "It is important that the medical community continue to promote clinically appropriate testing so we don't backtrack on these gains. With less frequent Pap screening of women, TERC testing is an important tool to ensure women are evaluated reliably and receive the proactive treatment that may prevent malignancy."
Omar Ford, 404-262-5546;
Published September 7, 2012