Member Info for TWatcher

From the Odx results
“CE mark and launch of Mologic's lateral flow antigen test for COVID-19, to be sold for professional-use under Omega's VISITECT(R) brand and FDA Emergency Use Authorization submitted”

Odx says it’s for professional use. Random Twitter guy ramps it is for self test, many here who know it’s for professional use stay stum, as it suits their purposes for this disinformation to be spread.

Tweets talking about self test in the US, slight problem is that mologic has applied for professional use EUA, not self test.

Turtle

Thanks for that info. How long since your last jab.

The MHRA is asking providers of laboratory-based COVID-19 antibody testing services.

“Laboratory based”

"don't care if i'm wrong"

that's the spirit, just call someone out for something, and don't care if your wrong.

wadogara, I have never commented on Abbott or Roche revenue projections. I note you couldn't even remember which company you were talking about, but could cleary remember it was me that commented on their downgrade, it wasn't.

In relation to USA, what I have said is that some are promoting the FDA EUA approval as certainty of massive sales. Right now, there are 20+ antigen LFT tests that have FDA EUA approval in the USA, and of them 9 have home test approval.
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2

Mologic's application is for professional use only. And there is still no timeframe to work with as to how long it'll be before the approval happens.

Techbadger,

it appears to me (totaly layman) that they have just pulled together other peoples resources and as such probably don't need a big head count. Looks like the antibody test came from Mologic. They already had the barrel test system and the surrounding kit from the HIV, and given that got self-test approval over 6 years ago, and as its the exact same process for the user, that usability element of the test is probably a given. They have then outsourced manufacture to ABDX, who are well versed in the kit, as they are the ones that manufactured the hiv kit.

So I guess biosures input was primarily applying for the whatever validatations (in this case ce- self test approval), and then marketing, distribution and sales.

This is not a new company, and they do have history in producing an innovative test with an extremely small head count, i.e. the previously mentioned HIV test was the first for self-testing in the UK over 6 years ago.

Okehurst1
"Do they have MHRA approval to sell direct to the public with no medical training and if so can she forward her MHRA accredition for same - not HIV test "

I'm am satisfied that all the evidence strongly points that they have (or at least in their own mind have) the right to sell locally. The company is hardly going to tell me they have no legal right to sell the kit to the public with no medical training, having just sent me one a couple of days earlier, and with it available for anyone to order.

The quote from the MHRA seems very clear:-

"The MHRA confirmed to The Pharmaceutical Journal that there is “no regulatory reason” finger-prick antibody tests, used within their CE-marked scope, cannot be put on the market in the UK,"

it says tests can be marketed in the UK on the basis of its CE approval, and its CE approval is self-test, i.e. tested by the person that wants to be tested.

"It’s looking like no chance Biosure secured MHRA approval to be the only company in the world to be allowed to sell a DIY Covid test direct to the U.K. public, especially with the vaccine waning / no 3rd jab for the masses, these guys have took a flyer to grab a quick £buck."

Someone has to be first, and you could say no chance a 11 person company could be the only test in the world to get home-test approval for HIV testing in the UK, but that's exactly what they did 6 years ago, as confirmed on the MHRA website itself. "Biosure is the only HIV self-test kit currently approved in the UK" (dated March 2015)

"MHRA were just confirming no reason they couldn’t be used under CE accreditation"

To be fair that's not what the quote said, the quote said it had to be used within its "CE-marked scope". The biosure one is CE self-test approved. (as opposed to the RTC test, which is ce marked for professional use).

"gain the first CE marking specifically for self-testing for COVID-19 IgG antibodies, a legal requirement for selling in the UK and Europe "

That last line is particularly interesting:-

"The MHRA confirmed to The Pharmaceutical Journal that there is “no regulatory reason” finger-prick antibody tests, used within their CE-marked scope, cannot be put on the market in the UK,"

MHRA says its ok to market CE antibody fingerprick products in the uk, provided they are used within their CE scope.

The CE scope of the biosure product is self-test.

And from February this year :-

https://pharmaceutical-journal.com/article/news/government-begins-recruiting-volunteers-to-evaluate-finger-prick-covid-19-antibody-tests

“Our plan is to ensure the BioSURE COVID-19 antibody self-test will be available through our usual consumer channels, which would include direct sales on our website, and community and high street pharmacies,” she said.
“We are currently awaiting regulatory approval; however, once we receive this, we are set for mass production,” she added.
The MHRA confirmed to The Pharmaceutical Journal that there is “no regulatory reason” finger-prick antibody tests, used within their CE-marked scope, cannot be put on the market in the UK, but pointed to the PHE advice advising against their use.

This MHRA page (from Dec 2015)
https://www.gov.uk/government/news/ordering-hiv-self-test-kits-online-make-sure-you-get-the-right-kit

Has a quote towards the bottom mentioning the biosure HIV test as the only hiv self-test kit approved. So that is where their entitlement to display MHRA is coming from. Unlikely that the MHRA are going to allow a quote on their website citing self-test approval if the MHRA have not approved it.

And given they have been registered to sell the HIV kit in the UK by the MHRA for 6 years (and were the first kit to do so), I think it is unfathomable to suggest they have decided to chance their arm and sell the antibody kit without the right to do so, given they held off selling it for a year.

They started seeking approval over a year ago, even before the RTC.
https://www.telegraph.co.uk/global-health/science-and-disease/makers-home-antibody-test-seek-urgent-nhs-approval/

The article from May 2020, says they were going to sell it "next month". Obviously they didn't. Now they are as of 25th of August. Given they didn't sell it for a year, and now they are, it would strongly suggest something has changed.

best to leave him wondering, no point in someone effectively unfiltering my postings for him if he doesn't do it himself.

Gman, was just coming to post the same thing.

I note that biosure at one time had a tri-antibody test, likely the same as ODX, and if so both would have come from mologic.

https://www.biosure.co.uk/tests/triple-antibody/

Just like the ODX one, it's disappeared of the face of the earth !. Given the date of that PR piece, it's around the same time that ODX was TTing it from mologic.

But given we now know that biosure has a relationship with mologic, its not impossible that this test has also come from mologic. Biosure does say the test was designed and developed in the uk.

Okehurst, the delivery was from England, not N.Ireland, so nothing to do with N.I. it appears. It was just a hypothesis of mine.

It is worth remembering that ABDX signed a distribution deal with biosure to sell the ABC-19 test back in March.
https://www.abingdonhealth.com/news/antibody-test-distribution-agreement-biosure-uk/

"Bit more involved that swooping a bit of HIV buffer for some purchased stuff on the Internet "
"which is why I say " as long as the data is robust"

I'll take a look at the included leaflet this evening, there was some data presented in there, but I didn't look at it in detail.

I think the self-test approval is a case that it is exactly the same process and kit and instructions that they have had self-test approval for 5-6 years for a HIV self-test which is sold in boots amongst other places.
https://www.boots.com/biosure-hiv-self-test-10264279

So if everything is the same, and all you are changing is the buffer solution and the strip in the barrel, then as long as the data is robust, approval should be relatively 'easy'.

I'm not for one moment promoting biosure, just intrigued how they are able to retail a self-test that is administered and read at home by untrained end users, when we were told by CK that the reason why the RTC-19 test does not have home test approval was "in terms of covid tests, within the uk, in terms of getting self tests through the MHRA, the MHRA will only approval self test use if there is demand from the DHSC, and clearly they currently view antibody test as not a requirement, hence why we have not been able to get the full sign off on home testing" (Q16 in the Q&A)

The biosure website says: "The test has gone through a rigorous independent process to gain the first CE marking specifically for self-testing for COVID-19 IgG antibodies, a legal requirement for selling in the UK and Europe and has an overall accuracy of over 99%. "

In terms of where they got their biotech from, biossure says "Designed, developed and manufactured in the UK".

Also, individual packaging for retail sale makes it more expensive.

Forgot to add, that I sent a query via the biosure website last night regarding my negative test even though I am double jabbed. i got a response and had a back and forth email conversation passed 11pm.

I latterly discovered it was the CEO herself that I was corresponding with. Offered to send me another test in a couple of week. Very impressive that the CEO picked up a generic web query and took to handling it late at night.

As well as selling the test, Biosure owns the test, and has contracted ABDX to manufacture them, so I would suggest much smaller margins for them than what you imagine.

Biosure selling them 4 for £100 on the website.

"Any difference in the price of Biosure & RTC 19 ?"

No pricing for the RTC product, which is only available from them in packs of 25.
biosure is £32.95 per test.

https://biosuretest.com/