Next few weeks9 Dec 2021 07:30
So we are expecting news that Abbingdon is able to mass produce our test this month (according to their RNS) and we are hoping for APAC news this month. Surely a yay or nay from EU on HUA due soon too. Outstanding results and independently done in Madrid and submitted to a notified body there. Hurry the duck up!!
Avacta is working with additional distributors in the Asia Pacific (APAC) region, and in other territories, to obtain the additional local regulatory approvals to place an IVD product with a CE mark on the market in those territories. These approvals are expected to be received in Q4 2021 which would allow for sales in those additional territories.
It is now widely expected that SARS-CoV-2 antigen testing will be a long-term market and will become a seasonal testing market similar to that for influenza. The high quality and excellent performance of the AffiDX (R) SARS-CoV-2 antigen lateral flow test puts Avacta in a strong position to gain market share in this long-term diagnostic market. In 2020 the total global SARS-CoV-2 antigen test market size (including PCR and other antigen test formats) was valued at $5.3 billion and is expected to expand at a compound annual growth rate of 6.7% from 2021 to 2027 ( source ).
The APAC region accounted for the largest portion of the market so far for SARS-CoV-2 antigen testing, representing 37.0% of the market in 2020(1) and, in the lateral flow testing market, there is a shift globally towards self-testing products. These market trends are key drivers of Avacta's AffiDX (R) SARS-CoV-2 antigen lateral flow test commercial strategy - to expand regulatory approvals in the APAC region and to bring a self-test product to market.
The regulatory approval of a self-test version of the AffiDX(R) SARS-CoV-2 antigen lateral flow test is a critical milestone because self-administered testing represents a significantly larger commercial opportunity than professional use testing. Avacta is working closely with its partner Medusa19 to support Medusa19's application for a CE mark for an AffiDX(R) SARS-CoV-2 antigen self-test. Good progress is being made in this regard with the submission of the regulatory documentation to a notified body in Europe. Medusa19 and Avacta are currently awaiting the response of the notified body and will update the market when a response is received.
The AffiDX(R) SARS-CoV-2 antigen lateral flow test is being manufactured by Global Access Diagnostics and the transfer of this process to Abingdon Health is now being validated to allow commercial product to be manufactured and released. In combination these two UK-based manufacturers will be able to supply 3-5 million tests per month. Further capacity, if required, is being put in place in Europe and potentially in Asia