Issue Date: June 19, 2017 | Web Date: June 14, 2017
Thermo Fisher reveals first-of-its-kind clinical analyzer
Thermo Fisher Scientific has unveiled what it calls the first automated, easy-to-use liquid chromatography/mass spectrometry analyzer aimed at the clinical diagnostics market. The small-molecule analyzer is the latest example of a push by scientific instrument makers out of the research lab and into hospital and testing markets.
The instrument, the Cascadion SM Clinical Analyzer, puts Thermo Fisher “well ahead of its LC/MS peers” including Waters, Agilent, Sciex, and Bruker, in the immunoanalyzer market, says analyst Puneet Souda of Leerink Research in a note to clients.
Souda values the market at $7 billion to $10 billion per year. It’s dominated by Siemens, Roche, Abbott, and Beckman Coulter, which use chemiluminesence and other techniques.
LC/MS analyzers have been used in clinical labs for decades, notes Robert DeWitte, clinical diagnostics research vice president at Thermo Fisher. But although they can provide greater sensitivity and accuracy than traditional immunoassays, most LC/MS systems must be operated by highly trained scientists.
The Cascadion analyzer, which Thermo Fisher is showing off at the EuroMedLab meeting in Athens this week, is intended to be run by a technician who loads samples and can walk away for up to four hours, DeWitte says. Bar codes affixed to samples instruct the machine on the assay to be run.
Unlike conventional LC/MS clinical analyzers, which are set up to run batches of one test type at a time, the Cascadion will be able to run sample tests in any order, DeWitte says. Thermo Fisher is developing test kits for vitamin D, testosterone, and immunosuppressant drug monitoring.
In time, the firm expects to develop kits to monitor both abused and therapeutic drugs. It also expects to develop endocrinology assays for the Cascadion, DeWitte says. Neither the kits nor the Cascadion itself have received regulatory approvals. Thermo Fisher expects approval in Europe sometime in 2018 and in the U.S. thereafter.
When it does receive approvals, Thermo Fisher hopes the system’s ease of use will attract customers at testing labs and smaller hospital labs who are now reluctant to invest in a complex LC/MS system.
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