News Due in March10 Mar 2021 13:00
--BAMS (Imminent)
This evaluation is expected to continue for another two or three weeks (from the 24th Feb update) and the Group is establishing outsourced manufacturing capacity for the BAMS tests in collaboration with Adeptrix so that it is in a position to formally validate the diagnostic product as soon as possible. Avacta is also in discussions with a large commercial partner to provide a route to market for the BAMS assay.
--- ISO accredited (end of March)
The Diagnostics Division has established a Quality Management System and the first external audit by the Group's Notified Body (BSI Group) was passed in December successfully. The second and final audit is scheduled for March 2021. A positive outcome of the second audit will lead to ISO13485 accreditation. This certification sets the organisational and operational framework for all current and future diagnostic product developments and it is an essential accreditation that underpins future commercial success.
---LFT CE MARK and SALES (End of March)
On the basis of these excellent initial data, the Group will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.