Member Info for Muck165

Me too! Any idea why the drop?

Agreed - and if we haven’t already done so, we must be very close to completing TT.

All hands to the pumps....

I know we’re more interested in our RNS, but the ODX one today has relevance for us too

“Update on UK Government manufacturing contract

The Company remains in regular dialogue with the Department of Health and Social Care ("DHSC") to provide manufacturing capacity for COVID-19 lateral flow antigen tests utilising the key pieces of manufacturing equipment loaned by the UK Government for that purpose. Omega is still waiting for confirmation on which test it will be required to manufacture. Omega is not in control of this process and this is taking longer than originally expected but the Company will provide a further update once a test is confirmed. The ability to supply tests that are produced within the UK remains a key priority for the DHSC and to that end the DHSC have facilitated initial commercial discussions between Omega and potential partner companies with lateral flow antigen tests to potentially provide UK manufacturing services.

In the meantime, Omega is currently supporting the Government with additional cassetting and pouching services for other COVID-19 antigen lateral flow tests that are being deployed in the UK.

The Company can also confirm that as part of the UK Government manufacturing contract announced on 11 February 2021 it has received cash Preproduction Payments totalling GBP2.5m (excluding VAT), with GBP2.0m of this cash payment received after the year ended 31 March 2021. It is expected that an amount per test, sufficient to recover the Preproduction Payment, will be deducted until such time as the funds have been repaid.”

https://bidstats.uk/tenders/2021/W22/752156936

Only a market engagement exercise at this stage, but something RMS should be v interested in I think.

If anyone’s interested, here’s a quote from the round table event held end of May -

https://www.fda.gov/media/149660/download

“ It’s neutralizing antibodies and fully quantitating antibody assays are a top priority, high priority, for serology tests.

As an aside, Chris Tranter (MD of Ginolis UK) very often likes ABDX LinkedIn posts, but I’ve noticed now that this chap has also started to do so -

https://www.linkedin.com/in/michael-severino-15848927/

He is a Ginolis sales manager based in New York. For those unaware, Ginolis supply the manufacturing machinery to ABDX, and also supplied the same kit to HMG for ODX to use.

I suppose my only observations are that the FDA are hot on Nab tests at the mo, ABDX are clearly looking to serve the US mkt (see the ABDX site), and ABDX are getting interest from US participants (Ginolis aren’t the only ones...)

ABDX are required to updated their website every 6 months to identify major shareholders - this falls due on 14 June. It will be interesting to see what, if any, change there’s been to the Touchstone holding, being the only one now out of lock in.

https://www.abingdonhealth.com/investors/aim-rule-26/

On 19 May the FDA issued a warning about the incorrect use of Ab tests to assess immunity -

https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety

This was discussed in their virtual town hall event held the same day, the transcript of which is here - https://www.fda.gov/media/149074/download

The interesting things for us are found in the questions from Jackie Chen on p8-9, and then again on p19-21, and the FDA responses to them.

Seems clear from these that the FDA priority is on neutralising Ab tests, as well as truly quantitative Ab tests, and that they want to see studies conducted in conjunction with a specific vaccine. ABC19 may not be quantitative, but it fits the other FDA priorities I think.

A quote from the transcript

“So, just to clarify, we are accepting serology submissions as Toby mentioned at the beginning and these are to detect antibodies, the presence of antibodies, to SARS-CoV-2. And we are certainly accepting neutralizing antibody submissions that, you know, that remains a priority for us along with I would say truly quantitative serology tests now that there’s an International standard. What we don’t have is data to support say the level of antibodies that are present to SARS-CoV-2 and in the presence of neutralizing antibodies and the level of immunity.

The US Government is funding, you know, several studies to address this question. It is an important question and certainly developers can approach this as well if they wish. You know what we’re really looking for is data that tells us about, you know, immunity. What is protective, you know, and what’s the correlate to the neutralizing antibodies or the level of a truly quantitative antibody test, you know, to immunity.”

https://avacta.com/wp-content/uploads/2021/05/Avacta-ARA-2020.pdf

Biosure tell me the Vatic test is launching end of June, which may be relevant for us if we are involved in manufacturing it.

Noted this from the AVCT annual report today

“ In order to participate in tender contracts offered by the
UK Government, the AffiDX® SARS-CoV-2 Antigen Lateral Flow Test has to pass an evaluation process at the UK Government’s Porton Down facility. The first stage of the evaluation process does not use the lateral flow test in
the manner that it was designed for and there is therefore uncertainty as to whether the test can pass the Porton Down evaluation process which could delay the ability to tender
for government contracts. The Group is progressing the clinical validation and CE marking of the product so that sales channels (other than the UK Government) can be exploited regardless of any delays in obtaining UK Government approval or tenders.”

Noticed this chap was recruited in April to be our Operational Readiness Manager

https://www.linkedin.com/in/rob-edwards-b5b19688/

Just another recruit to add to the list over the last few months!

We all focus on AVCT and ABC-19 here, but we know we are working with others. We just don’t know, for sure, who they are.

There’s a general consensus that the international is likely to be Sona Nanotech. They could be interesting when their V2 test has gone through trials. Nobody will want their V1.

One other could well be Vatic. I only say so because ABDX staff have, since the turn of the year, consistently like Vatic LinkedIn posts, and they have a CE marked and MRHA registered test. If we are working with them then it’s worth noting that Vatic seem to have attracted funding and are growing in prep for a commercial launch. Hers just some people they’ve recruited in the last month or so;

https://www.linkedin.com/in/justmarked/
https://www.linkedin.com/in/johnbauckham/?originalSubdomain=uk
https://www.linkedin.com/in/yorickm/?originalSubdomain=uk
https://www.linkedin.com/in/alickvarma/?originalSubdomain=uk
https://www.linkedin.com/in/paul-trainor-mcips-42668142/?originalSubdomain=uk
https://www.linkedin.com/in/jonathan-ripley-07b31bb0/?originalSubdomain=uk

Of course, we might have nothing to do with them!

https://www.knownow.com/

Something about to happen? Can sell everything on HL but NT to buy anything, even 1 share

Sorry, extract is actually from q16

Hi JDT - I’ve been wondering about this too.

There’s loads of guidance on this within in the U.K, but I found this the easiest to get my head around -

https://ec.europa.eu/health/sites/default/files/md_sector/docs/covid-19_ivd-qa_en.pdf

In summary, this suggests to me that a notified body (like the MRHA) need only be involved if the test is intended to be used as a self test. That’s confusing, of course, because the RNS made clear that we are CE marking for professional use only???

From q17 in the link

The precise role of notified bodies for different types of products is described in the relevant legislation. For IVDs under Directive 98/79/EC, they are involved in the assessment of self-tests (intended for lay users) and certain high-risk devices listed in Annex II of Directive 98/79/EC17. For COVID-19 tests, notified bodies are not involved in conformity assessment of tests intended for professional use, as these are not listed in Annex II. However, they do have a role for COVID-19 self- tests (i.e. those intended for lay users). For these tests, the manufacturer must submit an application to a notified body for the assessment of the design of the device, e.g. the suitability, for the lay user, of handling and information included on the label and instructions for use. Following a positive assessment, the notified body will then issue an EC design-examination certificate18. The assessment is usually by document review and not by physical testing of the device.

Notified bodies are not responsible for affixing the CE marking on the device, as this is the duty of the manufacturer. Notified bodies only issue the certificate for the specific activity that they have carried out. For a COVID-19 self-test, the manufacturer will not be able to affix the CE marking until the notified body has issued the relevant EC design-examination certificate.”

There is no doubt an obvious explanation, I just don’t know what it is!

He’s been posting on the NEX and VEL boards today so it be worth trying to contact him through those..

Never hurts to try! Am sure it will be passed to Julia for a reply shortly.

I didn’t know anything about Chris Twelves so looked him up - quite the impressive chap!

http://leedscrf.nihr.ac.uk/about-us/meet-our-team/management-team/chris-twelves/

Very, particularly given that I think Singer are still managing out a seller.

Wouldn't a TR1 this evening or Monday morning, coupled with AVCT CE news, be wonderful!

Good to see Singer on the bid and off the ask -

Thanks for your efforts here Scardey - as you say, if you don’t ask....