Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Hopefully next week will bring better fortunes
Spot on sjpw, welcome to the realm of Antigen testing :). To answer your question, if tech transfer has nor started then it is not a validated batch that can be used for CE marking
CE marking isn't just about the end product. The WHOLE process has to be validated including manufacturing as the batch produced AFTER tech transfer will be the standard for the millions produced thereafter. I repeat again CE marking CANNOT be acheived before tech transfer.
Even the 10000 units produced for CE validation have to be tested against the PCR standard. Those that think this takes a couple of weeks need their head checked.
You cannot CE mark a LFT BEFORE Tech Transfer
I'm not doubting tech transfer can't be completed in 1 month. The real issue is the incompetance of the testing in place at the moment in terms of PCR capability for comparison. To believe this will get done in a couple of weeks with a test out by January is foolish thinking.
Tech transfer completed by Christmas, then 10000 LFT units produced for CE marking, which need to be tested against the PCR standard and finally getting the CE mark if they pass. Looking at end of Q1 methinks for a test to be on the market.
True sjpw, but the facts are in order to get the CE marking to sell an LFT for professional use, the tech transfer has to be done BEFORE the batch of 10000 LFT units are produced. This is to verify the manufacturing process that will be used will pass as well as the actual LFT itself.
If Mologic are talking about commencing tech transfer at the end of November I highly doubt it is their LFT being spoken about
It definetely isn't the mologic one as they expect to commence tech transfer at the end of November if the prototype LFT goes as planned
My point being, why specifically mention Avacta out of all the POC tests out there as we already know 3 POC tests are already being validated by the government.
Maybe the government don't order by the month, maybe it's months, i,e the NCYT contract for 14 weeks a few weeks back.
Not sure who is ahead but what we do know is Avacta were specifically mentioned by the Government in a document released last friday evening in regards to POC and lab based testing