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Enzo Biochem wins New York state health department approval for new cardiac assay

Enzo Biochem announced that the New York State Department of Health has granted conditional approval for use of Enzo Clinical Labs’ PLAQPRO™ Lp-PLA2 Assay.

This cardiac assay delivers improved consistency and is designed to work on open platform clinical analysis instruments.

The open platform configuration is one of the several factors that contribute to its cost effectiveness, which is vital to today’s clinical labs that are confronted by shrinking reimbursements.

Elazar Rabbani, Ph.D., Enzo CEO and Chairman, commented that “the approval of PLAQPRO™ Lp-PLA2 is a strong addition to Enzo’s comprehensive cardiac testing panels, and is especially important to women’s health.”

“Often a woman will have no symptoms of heart disease, yet it is a leading cause of death for women in the United States accounting for an estimated 500,000 female lives lost each year. The assay is an important addition to Enzo’s expanding line of women’s health products, while also helping to solidify Enzo’s position as a leading full service women’s health lab.”

PLAQPRO™ Lp-PLA2 Assay is a biochemical activity assay designed to identify lipoprotein-associated phospholipase A2, a marker associated with the potential for coronary heart disease.

The PLAQPRO™ Lp- PLA2 Assay can be useful as part of a cardiac testing panel for individuals at intermediate or high risk for developing coronary heart disease. Early identification of increased risk of developing coronary heart disease offers the opportunity to adjust patient lifestyles or utilize medical interventions to reduce risk. The assay was developed using the Company’s strong expertise in assay development, antibody production, small molecule chemistry, and detection technology.

Dr. Rabbani emphasized Enzo’s commitment to delivering a robust line of products and services that will provide medically relevant, cost effective solutions that are easily adaptable to the workflow of clinical laboratories.

The Company’s integrated Life Science-Clinical Lab structure continues to be instrumental in its ability to seamlessly develop and advance products from innovation and manufacturing in our life sciences group and validation and commercialization through our clinical laboratory.

Enzo’s proprietary platforms, ranging from DNA-based technologies to cellular analysis, and the assays based on them, continue to provide more sensitive diagnostic information at lower costs than many other tests currently on the market. The Company’s recently approved assays are the forerunners of a comprehensive line of open diagnostic products under development by Enzo to address the critical needs of clinical laboratories.

Currently, laboratories are often locked into closed-system contracts with molecular diagnostic suppliers that, faced with ever-declining reimbursements, reduce or even eliminate operating margins.

The Company’s development pipeline includes an extensive line of assays for detection of numerous women’s health infectious agents as well as for the identification of other pathogens. The Company is also developing a proprietary line of products designed to aid pathologists in differentiating the characteristics of various tumors from biopsy specimens.