EarlyCDT-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.”
EarlyCDT-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.
About Enzo Biochem
Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and therapeutics through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and rapidly deploy products systems and services that meet the ever-changing and rapidly growing needs of health care both today and into the future. Underpinning Enzo Biochem’s products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies.
About Oncimmune
Oncimmune has a single goal: to advance early cancer detection to the greatest extent possible using autoantibody assay technology through the Early Cancer Detection test (“EarlyCDT®”). The company’s mission is to develop early cancer detection tests to identify more than 90 percent of solid-tumor cancers, which make up 70 percent of all cancers including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian.
Except for historical information, the matters discussed in this news release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses are dependent on a number of factors outside of the control of the company including, inter alia, the markets for the Company’s products and services, costs of goods and services, other expenses, government regulations, litigations, and general business conditions. See Risk Factors in the Company’s Form 10-K for the fiscal year ended July 31, 2012. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.
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Contact:
For Enzo Biochem, Inc.
Steven Anreder
Anreder & Company
212-532-3232
steven.anreder@anreder.com
or
Michael Wachs
CEOcast, Inc.
212-732-4300
mwachs@ceocast.com