10 August 2022 - - Switzerland-based diagnostic solutions provider Abionic SA's Pancreatic Stone Protein test on the abioSCOPE has been certified by BSI certification agency as complying with the European In-vitro Diagnostic Regulation, EU 2017/746, the company said.

This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union.

The IVDR's extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022.

IVDR becomes mandatory as of May 26, 2022. There are also transitional rules that will allow well-established instruments that have not been IVDR certified, but that entered the EU before, to still be sold until 2025.

Depending on their shelf life, they may also be used after 2025. Abionic has been preparing for IVDR compliance since 2019, and chose BSI, a reputable notified body that was authorized to perform this certification process.

Two years after the commercial launch of its sepsis test, Abionic's expansion is reaching a global scale.

With over 50 markets already covered, Abionic's next big step is the US where sepsis represents the single largest cost to the healthcare system. Clinical trials to support FDA 510(k) submission are well underway.

Founded in 2010, Abionic is a Swiss Medtech company commercializing a revolutionary nanofluidic technology, providing healthcare professionals with a fast, simple and universal diagnostic tool.

Abionic said its nanotechnology enhances the efficiency and versatility of standard ELISA tests to deliver optimal point of care treatment options by reducing current biological measuring techniques from the macroscale down to the nanoscale in a multi-analyte environment.

Abionic's In Vitro Diagnostic platform provides lab-quality ultra-fast results from a single drop of patient sample (saliva, blood, urine, etc.) at the POC enabling personalized diagnostics and opening the window of opportunity for immediate treatment.

The company is mainly active in acute care and in primary care (COVID-19, allergy, iron deficiency) businesses.