Product News: Enzo Biochem's Clinical Labs Introduces Diagnostic Test That Assists In Early Detection of Lung Cancer

20 Nov 2012

Enzo Clinical Labs has introduced a new diagnostic test that assists in risk assessment and early detection of lung cancer. It is being made available to physicians in the New York metropolitan market as well as New Jersey and Eastern Pennsylvania, where Enzo is the only clinical laboratory making the test available within those areas.

Early CDT-Lung has been approved by the New York State Department of Health. Utilizing a simple blood specimen, the test is directed at patients with a high risk of developing lung cancer, including heavy smokers, those exposed to suspect environmental conditions, and patients with a CT nodule under surveillance.

“The addition of this valuable new test at Enzo Clinical Lab is another example of our Lab’s strategic direction, which is focused on providing molecular and esoteric diagnostics that medical practitioners increasingly are relying upon to more timely and effectively predict and treat diseases,” said Barry Weiner, Enzo Biochem’s President.

The availability of EarlyCDT-Lung by Enzo Clinical Labs is the result of an agreement with its developer, Kansas-based Oncimmune®. The agreement provides for Enzo to be the only clinical laboratory located within its marketing area to make the test available to physicians.

“The EarlyCDT-Lung agreement is recognition of our Clinical Lab’s ability to reach an important segment of physicians in one of the nation’s major market area and of our capability for delivering outstanding assay results, which we have demonstrated with our ColonSentry™ offering. ColonSentry™, since its introduction just a few months ago, is growing in use as an early warning test for indications of possible colorectal cancer and the need for a colonoscopy for more extensive investigation,” said Mr. Weiner. “Similarly, EarlyCDT-Lung, when used in conjunction with diagnostic imaging, has the potential to aid in the identification of possible lung cancer when treatment can be most successful at a very early stage.”

“We at Oncimmune are pleased to partner with Enzo Clinical Labs in offering our EarlyCDT-Lung assay in the metropolitan New York area,” said Dan Calvo, CEO of Oncimmune (USA). “Enzo Labs’ outstanding facilities and experienced personnel make Enzo an ideal partner to make available this important assay, which we believe can improve the well-being of the many individuals at risk for developing lung cancer.”

Early CDT-Lung uses a panel of tumor antigens that are selected for their involvement in the development of lung cancer. Autoantibodies form and circulate in the body at all stages of the disease including Stages I and IIA, which are the earliest stages of lung cancer. Their measurement may signify the presence of cancerous cells.

The Oncimmune immuno-biomarker platform (EarlyCDT-Lung) provides increased sensitivity while maintaining higher levels of specificity than other single or multiple antigen tests. Elevation above a predetermined cutoff value of any one immuno-biomarker of the panel suggests that a tumor might be present. While risk assessment and early detection of lung cancer in asymptomatic high-risk patient populations are the primary benefits of EarlyCDT-Lung, it is also valuable as a follow-up test for high-risk patients who have indeterminate lung nodules identified by CT.