Attana Diagnostics - Expanded project scope with Linnaeus University and regulatory progress
Expanded Project Scope
The deepened collaboration between Attana and Linnaeus University is well under way and project preparation has been completed including the installation of a new Attana system and recruitment and training of project personnel. Non-clinical diagnostic testing will commence in the coming weeks with preliminary results scheduled for release in Q2.
As previously communicated, the initial work will focus on assay optimization and benchmarking of the Attana SARS-CoV-2 immunoassay. However, in light of the most recent COVID research showing reduced vaccine efficacy and therapeutic antibody response against certain SARS-CoV-2 virus variants, the project scope has been expanded to also look at how antibody interactions differ across the latest SARS-CoV-2 virus variants (SA, UK and NY).
In preparation for CE-IVD certification an independent evaluation of the Attana SARS-CoV-2 immunoassay will, in the coming few weeks, be performed by a leading IVD specialist research company. Upon completion, Attana will have its own diagnostic data supplemented by evaluations from both an academic institution and a commercial third-party. This combined data will form the technical basis for the various ongoing regulatory processes planned in 2021 as well as the new IVD-R requirements which will come into effect in 2022.
Additionally, Attana has begun preparations for partly supplementing its ISO 9001 certification with ISO 13485 standards to facilitate the transition from a supplier of laboratory equipment to also include IVD products for clinical diagnostic use.
“We are laying a robust foundation for our new diagnostics business unit: building a solid team, optimizing our initial product offering and strengthening strategic collaborations, all while ensuring that we conform to a complex regulatory landscape. It is extremely motivating knowing that our work today not only can have an immediate impact in the ongoing pandemic, but also lead to a pipeline of future innovations within in vitro diagnostics, ensuring Attana’s long-term competitiveness,” comments Samir Fostock, Head of Attana Diagnostics.
For more information, please contact:
Teodor Aastrup, CEO
+46 (0)8 674 57 00
The Board of directors for Attana consider that the information in this press release is not likely to have a significant effect on the share price but is of general interest for the shareholders and hence should be communicated.
Attana was founded in 2002 with the vision of in vitro characterization of molecular interactions mimicking in vivo conditions. Since then, Attana has developed proprietary label free biosensors for biochemical, crude, sera, and cell-based assays and the Attana Virus Analytics (AVA) platform, a proprietary in vitro diagnostics (IVD) tool. Attana products and research services are used by Big Pharma, biotech companies and academic institutions within the life sciences. To learn more about our latest services and products, please visit www.attana.com or contact firstname.lastname@example.org