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Siemens

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.

The agency cleared two Roche tests that run on its Cobas systems. One does Chlamydia trachomatis and Neisseria gonorrhoeae testing and the other does hematology testing.

Practice recommendations could serve as a guide for labs considering using the high-sensitivity assays as they become available, authors said.

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