Member Info for RegulatorUK

"The link doesn't work Regulator. The laws you have quoted are out of date. There's a national procurement process set out on the MHRA and DHSC site. You don't have to meet the TPp specification- you will be 'held on file' in case advice changes. So not much good to anyone who wants to sell in the UK. We will need MHRA approval as stated in ODX RNS."

The law I quote is not out of date. It is the law in force. I know this because it's one the things I have to take into account in my job.

You are conflating several things. There is a formal process laid out for the approval of medical devices (the 'CE process'). That is based on the EU and UK regulations (referred to in my previous process). Devices that are CE marked for professional use do not require MHRA approval - the manufacturer/distributor needs to be registered with MHRA and register the device.

There is also an emergency derogation process in place for novel tests that cannot be CE marked as they do not meet the IVDR requirements. That is a process administered by MHRA (as the UK competent authority), via the New Test Approvals Group (https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/process-for-developing-and-evaluating-novel-molecular-assays-for-covid-19). This does not apply to the UK-RTC antibody test as it has been CE marked for professional use. However, it will it will apply for self-test use as the UK-RTC test has not been CE marked for self test use (only for professional POC use).

There is also a government procurement process for a variety of diagnostics tests. Part of that was gaining approval from PHE (that appears to now be being transferred to NHS Test & Trace) - that applies to both CE and NTAG derogated devices. It does not apply to CE marked devices that will be sold on the general market (e.g. the Visitect Triple Antibody test) for professional use.

"Regulator - Do you happen to know, if WHO approval is granted for the Mologic (AB) Rapid test, does that approval apply to this Omega test as well, given it's the same test (to my limited understanding)? Or do Omega need to seek separate approval (if they want to go that route), under their own entity/brand? Similarly, do you think Mologic/Omega will go down the self test approval route too?"

My understanding is that ODX CE marks Mologic tests when they take them on, via an MTA, to sell under the Visitect brand. This is because ODX would need to register as a manufacturer/distributor in their own right.

"Regulator, MHRA have intervened to stop the sale of some tests in the UK so I assumed that would be a requirement? I think we would be flooded with poor quality tests otherwise. A CE mark is a quality standard but any qualifying body can award it can't they? Roche and Abbott had CE Mark's but they were withdrawn. We have already been CE marked and selected as preferred providers by dentists and some pharmacists but sales haven't started yet."

In respect of medial devices, access to the market is governed by the EU Medical Devices Directives (there are three) and the Medical Devices Regulations 2002 (the UK regulations implementing the EU Medical Devices Directives). The exact requirements will depend on the nature of the device - there are four main classes (Class I, Class IIa, Class IIb, and Class III). What is required in relation to each class is laid out here: https://www.gov.uk/guidance/medical-devices-conformity-assessment-and-the-ce-mark

If a medical device meets the requirements and a notified body approves and certifies it, you can then CE mark it. You then register the device with the MHRA (https://www.gov.uk/guidance/register-as-a-manufacturer-to-sell-medical-devices) - tehy don't approve it as such.

Things are in flux somewhat, as we're part way through a transition from the old 3 EU Directives (which date from the 1990s) to two new sets of EU regulations that came into force in 2017.

"....critical stage due to lack of testing facilities..... about time someone got their finger out and increased capacity."

Not easy to do, as the Pillar 1 and Pillar 2 tests (which is where the hold up is) are molecular tests. They require lab capacity and properly trained staff. NHS and PHE labs are at maximum. IS Health providers have a little spare capacity but will need it for their own staff.

The government/NHS Track & Trace want to create Lighthouse Labs, in partnership with universities and the biotech/pharma companies. Problem is much of the capacity there is already in use.

You can have all the machines you like (if you can get the reagents that is - don't forget every other country is after the same supply) - but the key component that's in real short supply is the qualified staff to run them.

We're reaping the rewards(?) of having failed to invest properly in developing out life sciences sector (beyond tax breaks and planning breaks for large pharma).

"Visitect antibody test is a different test. They don't need to wait for government orders for that. Just waiting for MHRA approval."

They don't need MHRA approval for the Vistect test, as it is a CE marked professional use POC test.

"...sounds plausible. they maybe being cheeky by getting some marketing out there so they can sell beyond the gov order. That's where the real cream is."

Not really. The test that is the subject of the tweet is the Mologic/Visitect IgA, IgG, IgM Triple Antibody test. It is a professional use POC test only - not a self administered test.

It's part of ODX's wider catalogue and nothing to do the the UK-RTC/government IgG antibody test.

"VISITECT® COVID-19 IgM/IgA/IgG allows healthcare professionals to test anytime and anywhere.

The rapid diagnostic test supports necessary mass testing to fight against the #COVID19 outbreak.

For more information, visit http://omegadiagnostics.com/Products/COVID-19/VISITECT-COVID19MAG

#COVID #COVIDUK #COVIDTesting #ODX"

"As I said, I like ODX, but i'm merely trying to apply some perspective. Covid stocks are in fashion and people will do well out of it, without a doubt...........however there's a shelf life and that needs to be considered when deliberating market caps"

ODX isn't just a Covid stock, you moron...

*Sorry that should be 2024 - not 2014.

"Thanks for stating the obvious Regulator.............however you conveniently ignore the fact that Mologic will be taking their cut. Margin figures indicated are wildly optimistic.

Also MU345, there won't be annual demand for this product. Be lucky if they get 2 years out of it"

Oh Lord... another one who's not done his basic homework.

Mologic and ODX have Material Transfer Agreements - a licensing agreement. Mologic will get a small fee for licesning for stuff sold under the ODX Visitect brand - but it is minimal.

As for how ling this will last, the international experts are talking about 2014 before there is sufficient vaccine capacity to bring this under control (not eradicate - only bring under control).

"Surely most the profit will go to Mologic? What's the split here? I like ODX but when you factor in the other partners interests, it shouldn't be valued in the same field as others. Manufacturing is typically low margin"

ODX can sell Mologic products under its own Visitect brand...

DYOR.

"I fully understand that this is a unique opportunity, but it would be really unusual for a business like Omega Tto be “allowed” (by government / customers / competitors) to generate and sustain the level of profitability contemplated by MB’s valuation."

You what? Do you know how business works?

I think you should step away from the computer and ask your mummy to put your pocket money into a Little Savers account for you...

Looks like we'll have a dip later this week as charity sells of Sneller's shares.

"I bought what I could at the time... Yay."

Same here.

"lol I didn't buy any in the placing, however I did buy a **** load on 14/07 at 33.75p best trade for a long time."

And again, same here - although mine were 35.24.

Something is needed to distract from Boris being handed his ar$e on a plate by Ed Miliband yesterday.

"Wonder what this will mean for syme and some of its UK funding.

https://www.finextra.com/newsarticle/36556/uk-banks-sign-fintech-pledge"

This is the government and the FCA giving the banks a very clear message - don't stand in the way of the fintech companies and don't screw over clients as you've done in the past.

Really easy to vote via message function in the H&L dashboard. I don't have a huge AMGO holding but every little helps.

I have a feeling that something might pop today.

"Some call it covid;others say winter flu"

It's not winter, you knob!

"Europe will see a rise in Covid-19 deaths through October and November, WHO warns as it casts doubts on effectiveness of a vaccine against the pandemic

https://www.dailymail.co.uk/news/article-8729977/amp/Europe-rise-Covid-19-deaths-says.html?__twitter_impression=true"

Usual conflated boll0x from the Daily Heil... pandering to the hard of thinking gammon.