Member Info for Greg22

How many other EU countries have home use approved tests manufactured in their own country? Everything still seems to be of Chinese origin. Please correct me if I am wrong but nobody seems to be able to sell a test in this pandemic outside of China. I therefore am not worried at all about ODX being behind the ball or not acting quickly enough. Holding until it comes good. Aston Martin dealer on speed dial when it does!

AUaddicted your autocorrect gave us a laugh so it wasn't completely wasted!

Could be good for ODX

https://www.kevinhollinrake.org.uk/news/visiting-global-test-manufacturer-sand-hutton

I was all excited for a moment until I opened the RNS link. Gives us good practice for when the real one lands.

I am happy leaving my money here and just waiting. Not much point buying an Aston Martin in the winter! It can wait until spring when I can enjoy it, otherwise I am in danger of spending it on booze, birds and fast cars and squandering the rest (to paraphrase George Best). If I had money to squander I would be an AIM trader with no patience!

Over here in Norfolk I can count the number of cases on one hand.....6!

Wadogara. My post wasn't intended to be personal against anyone just t remind investors that there is more to Omega than lateral flow tests. The tests do make up most of the company potential and this is why I see it as a long term and not a quick trade investment. As you said there are a lot of bedwetters here and if Colin is telling what he had for breakfast they worry their £100 is lost to an incompetent board of directors. I have steadily added to my holding over the past 20 months and I am a little bit under water due to buying lots last year in the 80's but, hey ho, that what happens. I can see this going well in the next 12 months and I have no intention of selling. My estimate is over £1 and less than £10 in the next 12 months.
Again, apologies if I caused you any offence Wadogara.

You are only estimating the Mcap for lateral flow devices, what about the other products they make and the move from Littleport to a bigger site at Ely for non covid products? I think the Mcap will be much higher when all the products are taken into account.

Radika. No joke, I really did buy some more.

Just added a few more. Setting my sell limit to £10 just in case!!!

I am but that is due to a lack of cash!!!!!

Sold my car reg plate and have some money to invest. Do I buy more?

What is the opinion? Are they miselling or just confused?

Their reply to me with the German certificate

"Thanks Greg
I can 100% confirm these are CE Marked for Self-testing and attached is the certificate for this, that is one of their major benefits and is why they are directly procured the to the DHSC (Department of Health and Social Care)."

For your interest, below is the link to this on ACON Laboratories website;

https://www.aconlabs.com/sars-cov-2-antigen-rapid-test-self-testing/
You may also be interested to hear that the Food and Drug Administration (FDA) have recently issued an Emergency Use Authorization (EUA) for emergency use of this product which specifically states home-use;

https://www.fda.gov/media/152700/download


Below is a screenshot from the FDA website;

Trust this is helpful and clarifies your question.

We would like to support you and can offer you the most competitive pricing in the UK due to our connection with the company that directly supplies the DHSC and our relationship with the factory for the UK & EU.

"The letter is the standard post-CE marking letter that MHRA sends. It shows that the relevant devices has been registered for marketing authorisation purposes - for professional use only.
It does not in any way indicate that it has passed the Porton Down process for HUA."

They sent me an email assuring me they are the only test to have full home use approval from MHRA. They don't as all they can supply s a certificate from Germany and a listing on the FDA website.

here is the "approval" letter. It says registered not approved!!

10 February 2021
Dear ******* ******
We are pleased to confirm that the application to register or update an existing registration for the following
manufacturer, which you submitted on 25 January 2021 has been reviewed:
Application reference: 2021012501191688
Manufacturer organisation: ACON Biotech (Hangzhou) Co Lt
Address:
No 210 Zhenzhong Road
West Lake District
Hangzhou
310030
China
Manufacturer registration status: Registered
Device(s):
GMDN term Status MHRA comment
64787 - SARS-CoV-2 antigen IVD, kit,
immunochromatographic test (ICT), rapid Registered
Please note this letter does not represent any form of accreditation, certification or approval by the UK Competent
Authority.
If you stop placing devices on the market or if you are not complying with the Regulations, you should inform us
so that we can amend our records. You should be aware that it is an offence to place on the market UKCA or CE
marked devices that do not comply with the regulations.
Please inform us of the following chargeable changes:
1. company/organisation information e.g. name and address
2. additional devices (GMDN code or term)
Please also use the Devices Online Registration Database (DORS) to tell us of the following changes e.g. removal/
discontinuation of a device (GMDN) or product from your registration record, change of contact person, telephone
number and/or email address, for which payment of our statutory fee does not apply.
Please note that the name and address of manufacturer, UK Responsible Person or Authorised Representative
(Northern Ireland only) and devices that have been registered will be published on our Public Access Registration
Database (PARD). This applies to non-in vitro diagnostic devices only.
The account number for your company/organisation is 0000011766.
Yours sincerely,
Ngozi Onyeukwu
Device registrations service
MHRA

ODX are not making their own test. They are making the test which is approved from a company who does not have the capacity to manufacture a test. ODX haven't sold a test as they aren't theirs to sell. ODX isn't waiting on approval but the company they will be working with to manufacture their approved device is and then they can pass it along to Colin to make.
I am happy with the way this is going, albeit slower than I imagined but getting there. I expect this to perform very well within the next 2 years as that is my plan. I keep adding when I can and let it sit there.

GTC. forgot to add please and thank you for taking the time to go to the site on behalf of us.

GTC what is the twitter link?

Get well soon Regulator.