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The company was encouraged by the clinical use of the existing handheld instrument in hospitals and soon plans to launch it with a broader menu, it said at AACC.
The Atellica assay's capability to assist with antibiotic therapy decisions can help address the rising problem of antibiotic resistance, Siemens said.
The Diagnostics segment's revenues declined 4 percent year over year, and currency translation impacted total revenues by 5 percentage points.
The agency cleared two of the firm's high-sensitivity troponin I assays for use on the Atellica IM and Advia Centaur XP/XPT immunoassay analyzers.
The investigators noted that the Siemens assay enables more institutions to introduce high-sensitivity cardiac troponin testing for patients outside the US.
The newly independent firm will continue to invest in diagnostics by bringing its menu of PCR tests for infectious diseases to the US and other markets, among other objectives.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
The companies will comarket an offering that includes Siemens Healthineers' DCA Vantage Analyzer for HbA1c testing and Clinitek Status + Urine Chemistry Urine Analyzer.
The company was spun out of Siemens earlier this year via a €4.2 billion initial public offering on the Frankfurt Stock Exchange.
The clinical analysis lab will use more than 50 Atellica clinical chemistry and immunoassay analyzers among 100 analyzers produced by Siemens.