Enzo Biochem and Flagship Biosciences partner to provide tissue-based companion diagnostics offering complete solution for in situ hybridization development to pharmaceutical companies
New York, NY – December 11, 2013 – Enzo Biochem Inc. (NYSE:ENZ) and Flagship Biosciences LLC, of Boulder, CO, today announced a partnership in tissue-based companion diagnostics that will enable personalized diagnosis and treatment of disease. The firms are working jointly with pharmaceutical clients that require an independent complete solution to the delivery of an in situ hybridization (ISH) companion diagnostic, which ultimately could have a major impact on drug development.
Flagship’s in situ hybridization services are overseen by pathologists and scientists to ensure the highest quality data.
The partnership brings together the strengths of Enzo, a pioneer in molecular diagnostics, and Flagship Biosciences, a leader in the use of quantitative tissue profiling for the development of companion diagnostics products. Flagship Biosciences’ expertise is in digital pathology, image analysis, cancer biology and regulated tissue-based assays, currently utilized by over 100 pharmaceutical and biotech firms in characterizing both diagnostic and therapeutic antibodies in drug development.
The partnership is based on the application of Enzo’s technology, reagents, and protocols (ISH) and analysis of nucleic acid in tissue which is being combined with Flagship’s software imaging and histopathology techniques to give a comprehensive package for pharmaceutical development.
Pharmaceutical and biotech companies increasingly include tissue analysis assays in their strategies for companion diagnostics. The companion diagnostics development process is highly regulated, and must be staged in parallel with therapeutic development. A successful ISH companion diagnostic program requires both an antibody/probe product or kit manufactured for use in a clinical environment, and a development team that can characterize the performance and testing environment.
Between Enzo and Flagship, pharmaceutical clients will be provided with a complete service for both the nucleic acid product and the companion diagnostics development and image analysis quantitation. Enzo today is currently providing a range of products and services for gene expression and chromosomal analysis. Areas of focus include women’s health and the identification of viral genes. Enzo Biochem is leading the convergence of clinical laboratories, life sciences and therapeutics through the development of unique diagnostic platform technologies that provide numerous advantages over previous approaches. Enzo utilizes cross-functional teams to develop and deploy products systems and services that meet the ever-changing and rapidly growing needs of health care. Underpinning the Company’s products and technologies is an extensive intellectual property portfolio, with patent coverage across a number of key enabling technologies.
“Enzo Biochem has been providing high quality products to researchers and clinicians for several decades,” said Mark Rees, Ph.D., Enzo Director of Business Development. “We are leveraging these strengths into new areas in tissue immunohistochemistry and in situ hybridization products. As we expand our capabilities into GMP manufacturing we are excited to be able to partner with Flagship Biosciences to combine our ability to deliver products with Flagship’s regulatory and pathology platform. Pharmaceutical clients can have both the stability and decades of experience in clinical products by Enzo with the fast-growing dominance of Flagship’s quantitative tissue platform and companion diagnostics development expertise.”
“Flagship has rapidly expanded from its initial expertise in tissue image analysis development in a regulated environment into histology, immunohistochemistry, and clinical trials services,” said Joe Krueger, Ph.D., Chief Science Officer for Flagship. “The remaining Flagship skill set missing from developing a complete ISH tissue diagnostics service was the nucleic acid product development. We are honored to team with Enzo and their resources for supporting in vitro diagnostic products. Together, we offer an independent, flexible, complete service for the development of companion diagnostics in anatomic pathology.”
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 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 Flagship Biosciences
Flagship Biosciences delivers quantitative histopathology services in pharma and device development and specializes in the development of tissue-based companion diagnostics. Flagship has a world-class team of pathologists, histologists, cancer biologists, image analysis scientists and regulatory experts. Their histology laboratory has optimized over 400 IHC antibodies since 2002, and they are working with fourteen of the fifteen largest pharmaceutical companies in quantitative tissue assays.
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, 2013. 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.
Source: Flagship Biosciences