Enzo will validate and seek approval of an Antenatal Infectious Disease panel as well as a thrombophilia panel pursuant to New York, New Jersey and CLIA [Clinical Laboratory Improvement Act] requirements, in addition to marketing, and securing third party reimbursement for the test. Terms were not disclosed. Enzo said that subject to regulatory and reimbursement approval, among others, it hopes to make the test available in the second half of 2010.
The tests bolster Enzo’s already strong portfolio of women’s health diagnostics. The antenatal panel allows for simultaneous identification of certain bacterial viral or fungal pathogens in a single convenient specimen. Additionally, the thrombophilia panel detects multiple mutations that can diagnose genetic predisposition to blood clotting.
“In our continuing mission to develop and offer cutting edge esoteric tests that provide our clients the best diagnostic tools that exist we are pleased to announce this alliance with MultiGEN,” said Kevin Krenitsky, MD, President of Enzo Labs. “These particular tests utilize true state of the art technology and offer physicians serving women highly accurate and convenient options for improved patient service.”
“Enzo Clinical Labs innovative capabilities in developing tests in New York State, combined with their existing commitment to offer world class diagnostics in the women’s health arena make them the perfect partner for us,” said T. Vinayagamoorthy, PhD., Founder and President of MultiGEN Diagnostics. “MultiGEN has developed a truly novel next generation multiplex sequencing technology that advances the accuracy and utility of these diagnostic tests and we are very pleased to begin offering them in Enzo’s highly populated geographical region. Early feedback in the test markets from the physician community has been extremely positive.”
About Enzo
Enzo Biochem, Inc., is a growth-oriented integrated life sciences and biotechnology company focused on harnessing biological process to develop research tools, diagnostics and therapeutics, and serves as a provider of both routine and esoteric test services to the medical community. Since its founding in 1976, the Company’s strategic focus has been on the development of enabling technologies in the life sciences field. Enzo Life Sciences develops, produces and markets proprietary labeling and detection products for gene expression analysis, nucleic acid detection, protein biochemistry, and cellular analysis, among others. Its catalog of over 40,000 products serve the molecular biology, cellular biochemistry, drug discovery and pathology research markets worldwide. Enzo Clinical Labs division provides laboratory services for a growing roster of physicians in the New York Metropolitan area, as well as New Jersey and parts of Pennsylvania. Its tests include, in addition to routine tests, capabilities for detecting molecular infectious disease, molecular oncology, autoimmune disorders and genetics. Enzo Clinical Labs also provides clinical diagnostic services that allow Enzo to capitalize on its extensive advanced molecular and cytogenetic capabilities and the broader trends in predictive and personalized diagnostics. Enzo Therapeutics is a biopharmaceutical venture that has developed multiple novel approaches in the areas of gastrointestinal, infectious, ophthalmic and metabolic diseases. It has focused its efforts on developing treatment regimens for diseases and conditions for which current treatment options are ineffective, costly, and/or cause unwanted side effects. In the course of the company’s research and development activities, Enzo has developed a substantial portfolio of intellectual property assets, with over 240 issued patents worldwide and more than 200 pending patent applications.
About MultiGEN
MultiGEN is an emerging molecular diagnostic company focused on DNA sequence based identification. Their unique platform technology is patent protected in the USA and internationally. MultiGEN is a novel modification of the well-documented ‘Gold-Standard’ DNAsequencing (Sanger method). This modification enables simultaneous identification of multiple pathogens regardless of whether they are bacteria, viruses, fungi or parasites. This capability allows a single drop of blood, for example, to be tested for a wide spectrum of organisms. This unique advantage dramatically reduces the cost per reported organism. Hence for the first time, DNA sequencing is made economical for routine testing. Other clinical applications include testing for genetic predisposition and cancer markers. The Company has a pipeline of assays that are at various stages of development. MultiGEN panel assays avoid physicians collecting multiple samples. In addition to having the most accurate and verifiable results, physicians can have the results within the same day for improved patient management. The Company operates a CLIA approved and CAP certified laboratory in San Diego, California, USA. MultiGEN has published in several peer-reviewed medical journals and is recognized by international health care institutions such as the WHO (World Health Organization).
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. 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.
Contact:
For: Enzo Biochem, Inc.
Steven Anreder, 212-532-3232 Or
Kevin Krenitsky M.D., President, Enzo Clinical Labs. 631-755-5500