Thermo Fisher Scientific, Waltham, Mass, has expanded its portfolio of analytical instruments for clinical diagnostic applications with the launch of three systems listed with FDA as Class I medical devices. The portfolio offers clinical diagnostic laboratories access to additional instruments that can be used to develop sensitive, robust, and reliable laboratory-developed tests.
The new instruments in the Thermo Fisher Scientific medical device portfolio include the Vanquish MD high-performance liquid chromatography (HPLC) system, and the TSQ Altis MD and TSQ Quantis MD mass spectrometers. The enhanced product portfolio is designed to increase the throughput of clinical diagnostic assays for the detection of small to large molecules within complex biological matrices.
“Clinical laboratories are under pressure to develop and optimize sensitive and reliable laboratory-developed tests that play an essential role in the diagnosis and monitoring of acute and chronic diseases,” says Bradley Hart, senior director for clinical research in chromatography and mass spectrometry at Thermo Fisher Scientific. “With the new MD portfolio of Class I medical devices with FDA, scientists in clinical diagnostic laboratories can now choose from a unique portfolio of liquid chromatography and mass spectrometry platforms to develop and optimize assays essential for clinical decisionmaking.”
Designed to bring high-quality analytical performance to clinical diagnostic laboratories, the TSQ Altis MD and TSQ Quantis MD mass spectrometers enable robust and sensitive analysis and quantitation of complex biological samples. The Vanquish MD HPLC system offers separation capabilities that can enhance the resolution of analytes.
The company’s MD portfolio is powered by TraceFinder LDT 1.0 software, which provides a software solution to enable regulatory compliance and management of clinical diagnostic workflows. In addition, Thermo Fisher Scientific has collaborated with BYG Informatique on a middleware solution that can enable seamless integration of data from TraceFinder LDT 1.0 to most laboratory information management systems used by diagnostic laboratories.
For further information, visit Thermo Fisher Scientific.
Featured image: The TSQ Quantis MD mass spectrometer from Thermo Fisher Scientific.