The varvis® software - now Class C IVDR certified

We are happy to announce that the varvis® software is the first IVDR certified Class C stand-alone device covering the entire process from raw data to genomic variant classification! The certificate also covers the CNV analysis. The varvis® software supports all clinical NGS applications - from NGS panels and exomes to genomes, cancer diagnostics and carrier screening and is specifically designed to aid in the diagnosis of patients. Click here to read the full press release.

The role of the IVDR conformity assessment in genetic diagnostics

Now that the regulation on in-vitro diagnostic devices (IVDR) explicitly regulates in-house devices, or laboratory-developed tests (LDTs), in the European Union, the selection of properly CE-labeled devices is increasingly important to health institutions like genetic testing laboratories.

In this Q&A, Sonja Strunz, our head of regulatory affairs, explains the classification of devices under IVDR and what it means for manufacturers, users, and patients. Read the article here.

About varvis®

The varvis® software is a clinical decision support system developed by Limbus Medical Technologies GmbH, a medical device and software development company. The cloud-based genomics platform is tailored to support the entire NGS workflow, from raw data processing to genomic data management and variant interpretation. Automated CNV and SNV analysis is fully integrated into the NGS workflow and clinically validated for panels of all sizes, including WES and WGS. Our services include first-class support, training, automated quality control and validation according to relevant international guidelines. The varvis® software is a certified CE-IVD device and is specifically designed to support patient diagnosis. Visit our website for further information.