PentaBase A/S

PentaBase INA® molecular diagnostics - highly sensitive PCR assays for cancer detection and monitoring. CE-IVD certified, distributed worldwide.

From the manufacturer's own website. Source

PentaBase A/S manufactures molecular diagnostics assays, including real-time PCR-based tests for detecting and monitoring cancer-related biomarkers, such as methylation and gene mutations (e.g., *MYD88* in Waldenström lymphoma). Their portfolio also includes assays for infectious disease detection, such as respiratory pathogens and SARS-CoV-2, as well as screening tools for genetic or epigenetic markers in clinical samples. The company produces both standalone assays and multiplexed diagnostic solutions for laboratory use.

The company’s products are classified under EU In Vitro Diagnostic Regulation (IVDR) categories, including Class A for general health tests and Class C for high-risk diagnostic assays, with several listed as IVD General. These devices are registered in the EU’s eudamed database, ensuring compliance with EU regulatory requirements. PentaBase A/S is headquartered in Denmark.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.