Siemens Healthineers reported today it has achieved 12 Pre-Market Approvals from the Food and Drug Administration for its infectious disease and oncology testing menu. This milestone means the companys Atellica Solution1 now provides laboratories in the U.S. with a comprehensive menu on a single laboratory platform for patients in vitro diagnostic testing needs.
These 12 PMA assays, combined with recently released High-Sensitivity Troponin I and Procalcitonin assays, provide a comprehensive menu on the Atellica Solution. Laboratories seeking a broad menu supporting the needs of their clinicians and patients can now find it on the Atellica Solution, said Deepak Nath, Ph.D., President, Laboratory Diagnostics, Siemens Healthineers.
The infectious disease tests new to the Atellica Solution include HIV2 (HIV Ag/Ab Combo (CHIV) and HIV 1/O/2 Enhanced (EHIV)) and Hepatitis B and C (Anti-HBs 2, HBsAg II, HBsII Confirmatory, HBc IgM, HBc Total, HBeAg and HCV), and provide physicians with testing options for hepatitis screening, diagnosis, and monitoring. Each of the PMA submissions required extensive supplemental data and performance studies to demonstrate reliable performance on the Atellica Solution. This accomplishment signifies the strength of the Siemens Healthineers assay menu overall.
To learn more about the Atellica Solution and its comprehensive assay menu, please visit
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1 Product availability varies by country. 2 HIV assays developed, manufactured, and sold by Siemens Healthcare Diagnostics Inc. for Ortho Clinical Diagnostics, Inc. and Grifols Diagnostic Solutions Inc.
Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services. In fiscal 2018, which ended on September 30, 2018, Siemens Healthineers generated revenue of ‚¬13.4 billion and adjusted profit of ‚¬2.3 billion and has about 50,000 employees worldwide. Further information is available at www.siemens-healthineers.com.
Kimberly Nissen, Siemens Healthineers
+1 610 448-6355; Email: [email protected]