Is it us? Not until Tech transfer confirmed20 Oct 2020 10:30
just a reminder that we are waiting on an RNS for tech transfer and until that comes we dont have a test available so none of these trials can be us, slide 30:
https://avacta.com/wp-content/uploads/2020/09/Avacta-Group-plc-Interim-Results-September-2020-v2.pdf
• The Affimer based lateral flow test developed with Cytiva is in the process of technology transfer to BBI Solutions.
This process involves scale-up of the manufacturing processes and optimisation of the performance of devices
manufactured with the scaled up processes; the first pilot batch will be 10,000 units.
Clinical validation can only be conducted on devices made using the scaled-up process to satisfy CE regulations.
We expect clinical validation to be completed in Q4 dependent on pilot batch availability. •
• The clinical validation and lay user studies are being designed with Liverpool School of Tropical Medicine. •
• Completion of verification and validation will allow Avacta to self-certify for professional use, and completion of the lay user study, will lead to an audit by AYacWa·V notified body for CE marking for consumer use. •
• When the manufacturing development phase is completed and the pilot batch is available, the timeline to clinical validation, CE marking and product launch will be defined more precisely.