CE Marking Received for New HIV-1 and HCV RNA Assays

CE Marking has been received for real-time PCR assays for rapid, quantitative determination in human plasma of Human Immunodeficiency Virus type 1 (HIV-1) and of Hepatitis C Virus (HCV) RNA using the high-performance DxN VERIS system.

DxN VERIS HCV Assay and DxN VERIS HIV-1 Assay are the two latest additions to the growing menu of CE-marked assays for use on the DxN VERIS Molecular Diagnostics System from Beckman Coulter Diagnostics (Brea, CA, USA) allowing for rapid turnaround and a more efficient workflow.


“Beckman Coulter is committed to the ongoing development of assays for DxN VERIS and aims to rapidly expand the DxN VERIS infectious disease portfolio, delivering assays that are both cost- and time-effective,” said Arnd Kaldowski, president, Beckman Coulter Diagnostics. “Tests can be up and running in 10 minutes and, with true single-sample random-access and the shortest turnaround time available, results can be delivered to physicians faster,” said Richard Creager, senior vice president, Molecular Diagnostics Business Unit, and chief scientific officer at Beckman Coulter Diagnostics.

HCV RNA quantification is invaluable for assessment and monitoring of patients undergoing treatment, helping to assess patient compliance, inform response‐guided therapy, and determine sustained viral response (SVR), which corresponds to cure in over 99% of cases. DxN VERIS HCV reliably detects genotypes 1 to 6, and is calibrated to the 4th WHO International Standard for HCV (NIBSC 06/102) using the DxN VERIS technology.

Similarly, quantitative measurement of HIV-1 RNA viral load in plasma plays a vital role in prognosis, management, and treatment monitoring of infected patients. DxN VERIS HIV-1 reliably detects subtypes: Group M (A, C, D, F, G, H); Group N; Group O; CRF AE and CRF AG11, and is traceable to the WHO International Standard for HIV-1 using the DxN VERIS technology.

Short assay run-times (less than 102 minutes for DxN VERIS HCV and less than 87 minutes for DxN VERIS HIV-1) enable faster clinical decision making. Automated sample processing, amplification, and detection enable the user to simply load the sample tube onto the DxN VERIS system, subsequent steps are performed automatically. All DxN VERIS assays are supplied in a unique single-cartridge system, reducing wastage and consumable costs compared to traditional batch-plate systems.

Additional CE marked assays for the system include DxN VERIS CMV Assay (for human Cytomegalovirus in plasma) and DxN VERIS HBV Assay (for Hepatitis B Virus in plasma and serum), with many other assays under development.

Related Links:
Beckman Coulter Diagnostics