Tepnel Pharma Services, part of Hologic, Inc. (Hologic or the Company), will introduce an expanded portfolio of regulatory compliant analytical services at CPhI 2013 (Convention of Pharmaceutical Ingredients). Two new analytical offerings will be introduced at the convention: Global Batch and Lot Release Service for manufacturers of proprietary bio/pharmaceuticals based outside of the European Union and, Tepnel’s Invader Chemistry Platform (ICP) Genotyping Service which incorporates Hologic’s proprietary Invader and Invader Plus technology.
The Global Batch and Lot Release Service will provide quality control testing for the release of pharmaceuticals and biopharmaceuticals manufactured by companies outside the EU. This new service is targeted at companies who wish to establish a supply chain for authorized products within the EU member states.
The new ICP Genotyping Service uses a scalable technology (HT >30,000 samples/hr) which has a simple assay design and an affordable price which can subsequently be developed into a genotyping assay for use in clinical practice. ICP is an isothermal, DNA probe based system for highly sensitive, quantitative detection of specific nucleic acid sequences which is both accurate and specific for the analysis of SNPs, InDels, CNV and Gene Expression that is designed to assist customers in the clinical trial, medical genetic and Companion Diagnostic (CDx) markets.
About Tepnel Pharma Services
Tepnel Pharma Services is the Contract Research Organization (CRO) group of Hologic. Tepnel specialises in the provision of pharmaceutical testing and molecular genetic services in support of drug development and companion diagnostic development. Tepnel’s pharmaceutical testing facilities are located in Manchester, England and Livingston, Scotland.
About Hologic, Inc
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems, and surgical products, with an emphasis on serving the healthcare needs of women. The Company operates four core business units focused on diagnostics, breast health, GYN surgical and skeletal health. With a comprehensive suite of technologies and a robust research and development program, Hologic is committed to improving lives. The Company is headquartered in Massachusetts.
Hologic, Invader, Invader Plus and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
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This Media Release may contain forward-looking information that involves risks and uncertainties, including statements about Hologic, Inc. and our products. There can be no assurance these products will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient. Hologic disclaims any obligation to release publicly any updates or revisions to the data or statements presented herein or to reflect any change in our expectations or any change in events, conditions or circumstances on which any such data or statements are based.
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