Member Info for Muck165

Hi -

As far as I know we are making product for Biosure (which are being sold), our own products (Seralite, PCRD, plant and animal disease tests) which again, are being sold.

We have AffiDx, which Avacta confirmed has completed TT and ABDX are currently (and may have finished) completing batch manufacturing for final validation. Currently for professional use only in the EU pending CTDA desktop review in the U.K., and awaiting HUA from pan EU notified body (likely in Spain).

Then we have Vatic. Not launching until January, but interesting because it’s saliva and supposedly mutation proof (although I’m not convinced about that).

In the near term AffiDx is the one I’m watching like a hawk because for a variety of reasons I think that’s where we have greatest potential. Vatic May come later, particularly if it gets HUA.

Just for awareness, this guy has recently been asking loads of questions in an attempt, it seems, to better understand how the govt awarded contracts and who was involved. Here’s the full list

https://questions-statements.parliament.uk/written-questions?SearchTerm=&DateFrom=11%2F05%2F2021&DateTo=31%2F07%2F2022&AnsweredFrom=&AnsweredTo=&House=Commons&MemberId=3913&Answered=Any&Expanded=True

One of these relates to ABDX

https://questions-statements.parliament.uk/written-questions/detail/2021-11-19/78382

Most of the questions are simply asking for meeting minutes, or who was involved in those meetings. Despite this, the govt has provided this stock reply to nearly all the questions Dromey has raised

“ The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.”

Like I say, I post for awareness. The guy seems to me to be on a sleaze discovery crusade…

Just in case this hasn’t already been posted, it’s a joint open letter from BIVDA and ABHI to the U.K. Health Security Agency, copying in the great and good at MRHA etc, bemoaning the CTDA process and it’s affect on smaller diagnostic businesses.

What I hadn’t seen before was the link in the letter which directs recipients to a Reuters news article about the withdrawal of tests by AVCT and NCYT.

So if the great and the good read the letter, and followed the link, they will be well aware of the effect CTDA has had on AVCT. Perhaps they did, hence why NCYT is one of the first to get approved through the process. Who knows.

https://www.ibms.org/resources/documents/abhi-bivda-ctda-letter-to-ukhsa-20211104/abhi-bivda-ctda-letter-to-ukhsa-2021.11.04.pdf

https://www.reuters.com/world/uk/two-uk-covid-test-makers-pull-devices-due-new-review-2021-11-02/

Sorry if this is old news..,!

And another!

https://jobs.cubedresourcing.co.uk/vacancies/2528/production-laboratory-technician.html

And some more posted today. Seems every time I look there’s another listing with Cubed - this time for “a number of technical transfer scientists”. Based in York and permanent.

https://jobs.cubedresourcing.co.uk/vacancies/2654/technical-transfer-scientist.html

Shouldn’t forget security of and volume of supply…that will be another major factor, alongside cost and accuracy, in determining success.

Can’t be quite as certain about these, but my guess is they’re for ABDX as well, given we have a site in Doncaster and cubed are our recruitment partner.

https://jobs.cubedresourcing.co.uk/vacancies/vacancy-search-results.aspx

Tbh, I’d forgotten about our Seralite product!! Just another string to the bow.

Can we get in the VIP lane. I can supply the brown envelope.

Can anyone help me understand what Medusa 19 Healthcare does?

Our distribution contract is with M19 Ltd, which was set up in April 20. M19 Healthcare was set up in Nov 20. Both have the same SIC code.

I ask only because the Meduflow “brochure” came from M19 Healthcare, but the trademark applications were made by M19 Ltd, and I’m just wondering what, if any, difference there is in the services offered by the 2 companies. As idle speculation, I suppose I’m wondering if Medusa Healthcare ( the company included in the Microbiology framework) might possibly be setting up as approved test provider?

Would just seem to make sense to try and do this if you also have agreement to distribute a great test.

Mine too Beret. ABDX have a few potential workstreams,

Vatic - interesting but not launching until Jan and it seems having to do more work to satisfy CTDA regs.
PCRD - for general use by others look to build a test. Sold 1m in the last FY but ABDX haven’t said anything about further orders.
Animal testing - can’t see this being significant
ABC19 - no take up and we must have existing stockpiles.

So that leaves AVCT - A great test for which we are finalising (or may already have completed) validation batch production , which has had an HUA application in for months, is supported by Medusa 19 who have been eerily quiet over those same months and are rumoured to have built significant manufacturing capacity, recently registered Meduflow as a trade mark, and were included in the NHS microbiology framework.

I know we have short term cash issues but I really do think there are plenty of options to deal with that (apart from a placing), and I do think great potential off the back of AVCT.

ABDX did say significant purchase orders have already been received!!

And another listing for a number of permanent full time production/assembly operatives, posted today

https://jobs.cubedresourcing.co.uk/vacancies/2045/production-operatives.html

Something must be going on..

The Atamis contracts linked to these bid stats notices confirm contract values of £144m and £62m respectively. See section 14

https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000QBz9/kgEhGyUxekk5mE0qYYShDabZPxBopXSYHj0KQf.NJGQ

https://atamis-1928.cloudforce.com/sfc/p/#0O000000rwim/a/4J000000QBzJ/rL3vWVrI5VJ.29REB7Ap_mY5YzZddAeI8M9tfh_TSTI

Aren’t the just call offs agreed back in June, and just published now?

Yet another vacancy posted today, for a Project Manager

“ Due to significant demand for their services, both with the COVID-19 piece and subsequently in many other areas, they are now recruiting for a Project Manager, to join the business on a permanent basis, who will be responsible for leading on various projects across the business.”

https://jobs.cubedresourcing.co.uk/vacancies/2586/project-manager--medical-devices.html

Apologies if this has already been posted, but the FDA updated their EUA prioritisation requirements last week.

“Moving forward, the FDA generally intends to focus its review on emergency use authorization (EUA) requests for the following types of tests:

At-home and point-of-care (POC) diagnostic tests for use with or without a prescription and that can be manufactured in high volumes;

Tests for which the request is from, or supported by, a U.S. government stakeholder, such as the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics.“

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and

Seems like Mologic/Odx hit both requirements…

I spoke with Julie Mitchell at Biosure this afternoon, the upshot of which was,

-They have now been told that Vatic will be launching at the end of January, not December.
- Delay is blamed on the CTDA regulations, and that further information needs to be submitted in this regard. This might explain Vatic LinkedIn posts over the last few months looking for Cat3 lab space and test volunteers.
- Biosure will be submitting an HUA version of the Vatic test under the Biosure brand. Julie suggested that this may also be approved by the end of Jan
- Julie was plugging the Antibody self test. She said that until recently, when some gentleman tweeted about it, they’d been selling “20-30” a day, but following the tweet they were up to 200-300 a day. She seemed very pleased with that…..?
- she confirmed that, as of right now, Biosure themselves don’t have any stock of their antibody self test, but one of their distributors does. She didn’t say who.

Won’t be music to peoples ears, but there we are…

On the positive, let’s hope we get some news on Avacta soon. In this respect it’s worth noting the recent FDA notice in which they clearly highlight prioritisation for home use diagnostic tests that can be manufactured at scale.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-updates-test-policies-help-ensure-accuracy-and-reliability-tests-and

Might be easier to see here

https://twitter.com/Vatic_Health/status/1460971235966341121

Might be nothing, but if you zoom into the picture in Vatics LinkedIn post last week, you will see the test pictured is called a Covid 19 Self Test.

https://www.linkedin.com/company/vatichealth/posts/?feedView=all

Am struggling to see why we’re still trading at this SP…

Oil price remains high
Gas price remains high, and is rising again
Exchange rate has been moving in our favour since June
Great new partnerships

I know the debt is perceived as high but it seems well managed and not of any immediate concern. Do we have a seller?

Like I say, just interested in views…

Can’t post a link because you have to log in to see it, but a current ABDX employee left this review on Glassdoor on 12/11

“ Pros
The people I work alongside are lovely and try to do their best despite the ridiculous expectations
The company does provide in house training.
Cons
The senior management in this business offer no long term direction, leadership or effective communication then berate staff when they haven’t prioritised whatever they were ‘supposed’ to have done from the ridiculous workload. There is no resource planning and an arrogant lack of understanding of what people do.
Advice to Management
Show some senior leadership”

The review pretty much mirrors others we saw from other reviews earlier this year, and of course anyone posting reviews are likely to be a little disgruntled.

But one phrase stood out for me - “the ridiculous workload”.

I wonder what that might be for.