AB Sciex is entering the field of in vitro diagnostics with two devices that can be used to analyze trace levels of multiple compounds in human samples: the AB Sciex API 3200MD™ and 3200MD QTRAP® LC/MS/MS systems.
“Clinical diagnostics is the new frontier for mass spectrometry,” said Rainer Blair, president of AB Sciex. “The introduction of the 3200MD series is a major milestone for AB Sciex itself in response to the demand in clinical settings for mass spectrometers as medical devices that meet regulatory requirements.”
The 3200MD series is the first of a family of in vitro diagnostic devices that AB Sciex plans to roll out in the future. The intended use of these devices is to identify inorganic or organic compounds in human specimens for clinical use.
The introduction of this new family of in vitro diagnostic devices follows AB Sciex’ announcement in February of 2012 that it obtained ISO 13485:2003 certification. ISO 13485:2003 is an ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
However, AB Sciex is hardly leaving its primary focuses behind. Just last week, they signed a multiyear agreement with the Institute for Systems Biology (ISB) to collaborate on the development of methods and technology in proteomics mass spectrometry, with the goal of redefining biomarker research and complement genomics through quantitative proteomics analysis. ISB will be using the AB Sciex TripleTOF® 5600+ System and an Eksigent ekspert™ nano-LC 400 System as the instrument platforms on which to conduct the protein identification and quantitation. Also, in October, AB Sciex released LibraryView™ software, which the company says can enable faster and more reliable identification of contaminants in food, environmental, clinical research, and forensic toxicology samples.