Original from: altona Diagnostics
altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.
The FlexStar® STI Panel supports qualitative detection and differentiation of key pathogens including Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), Trichomonas vaginalis (TV), Ureaplasma urealyticum (UU), Ureaplasma parvum (UP), and Mycoplasma hominis (MH). It addresses rising STI prevalence with adaptive multiplex PCR, allowing labs to select targets based on clinical needs, epidemiology, or guidelines while maintaining top-tier sensitivity and specificity. Validated for now on urine and genital swabs samples, it integrates into the AltoStar® Workflow and delivers PCR results in about one hour, following sample preparation.
CE marking in accordance with Regulation (EU) 2017/746 (IVDR) demonstrates conformity with the applicable requirements for safety, performance, and clinical evidence, using one amplification mix with interchangeable detection modules (e.g. CT/NG, MG/UU/TV, UP/MH).
The FlexStar® STI panel is fully integrated into the AltoStar® Workflow, enabling a streamlined, end-to-end PCR testing process from sample to result. Designed for seamless compatibility, FlexStar® assays align with AltoStar® instrumentation and software to support standardized processing, efficient throughput, and simplified laboratory operations. This integration ensures consistent performance, reduces manual intervention, and supports reliable, reproducible results within routine clinical workflows. AltoStar® Analysis can be added as an optional software solution for automated PCR result interpretation, helping reduce hands-on time, standardize review, and support reproducible, traceable results in clinical laboratories.
“With the launch of our first CE marked FlexStar® panel, we are entering the field of syndromic testing with flexible, compliant diagnostics designed to meet the evolving needs of modern laboratory workflows,” said Dr. Sönke Friedrichsen, General Manager of altona Diagnostics.
Source: altona Diagnostics completes IVDR transition for FlexStar® STI panel
