Cepheid
Rebecca Lange is a highly experienced regulatory affairs and quality assurance professional, currently serving as a Principal Regulatory Affairs Specialist at Cepheid since August 2021, where responsibilities include the assessment of post-market changes to in-vitro diagnostic medical devices. Previous roles at ZeptoMetrix Corporation included various positions within quality assurance, focusing on regulatory requirements, compliance, and documentation management, supplemented by experience in quality control at Fresenius Kabi USA. Rebecca's earlier career features a blend of customer service and office management roles, with a solid educational foundation in Biological Sciences from the University at Buffalo and qualifications in Science and Math from Erie Community College.
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Cepheid
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Cepheid is a molecular diagnostics company. The Company develops, manufactures and markets fully-integrated systems for testing in the Clinical and Non-Clinical markets. The Company's systems enable molecular testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The Company's systems integrate these steps and analyze biological samples in test cartridges. Its primary offering is the GeneXpert system, which integrates sample preparation in addition to Deoxyribonucleic acid (DNA) amplification and detection. The GeneXpert system is designed for a range of user types ranging from reference laboratories and hospital central laboratories to satellite testing locations, such as emergency departments and intensive care units within hospitals, as well as physician offices and other alternate site laboratories. It also offers the SmartCycler system, which integrates DNA amplification and detection to allow rapid analysis of a sample.