Member Info for flyingmachine

Mologic POC tests manufactured by Biosure do not meet minimum MHRA requirements and are not approved by PHE. Our edge is the the RTC sole purpose (set up by the Gov) is to provide an antibody POC test that meets these standards and can be approved by the PHE to employ in mass testing within the UK. The UK Gov is not going to use anything less - they can't afford to because of their previous shambles of ordering 17 million 'not fit for purpose' tests from China.

Dibs, you were looking for S&S figures for the Mologic POC test, here it is, from their 1st May News update....
"The Mologic test information are the rapid test POC tests that Mogic in their update of 1st May is 98% sensitivity at days 14-21 and specificity of 96%."
So does not meet minimum MHRA requirements so is not approved by UK Gov. The whole point of the RTC POC test is it will meet the MHRA requirements, so just be patient...

One thing that these Jersey tests illustrate is how urgent it is for a quality PoC antibody test. The sensitivity of the tests used in Jersey had a paltry 76-83% sensitivity, way below what the RTC POC are aiming for which is minimum 98% sensitivity. I am confident they are close or have already cracked it, just a matter of being patient. Once they announce it will be huge, not just in the UK but other countries too.

Eva, not sure why your post is under the heading 'oxford uni' since the failure of antibody tests in the USA are totally the responsibility of opportunist pharma's and the inadequate oversight of the FDA in their haste to overcome the early threat of the pandemic. The FDA are now trying to tighten things up over there....
https://www.fiercebiotech.com/medtech/fda-increases-oversight-requirements-for-covid-19-antibody-tests

Where the Oxford Uni are involved is the RTC POC whos purpose is to ensure a quality antibody test that meets the MHRA requirements and can be pushed out for the masses. I am confident they will achieve that purpose very very soon, and ODX will benefit hugely from that. The market in the USA for a quality RTC POC antobody test would also be huge.

Jollifant, tbh, we all know what he's doing.

Lucky, thanks for the link. So what you have referred this board to is an antigen PCR (lab based) test, to detect if you have the virus. Totally different to antibody tests and not relevant or in competition to what ODX are involved with.

Since you also post to NCYT and GDR I suggest you post your useful link over there as it is more important to them. I'll look out for those. Thanks

Since you also post to

Lucky, could you at least just name the US company please, so we can do our own research. My own research tells me that the FDA are cracking down on inaccurate antibody test which they let through in their panic to get on top of COVID-19 in the early stages....
https://www.fiercebiotech.com/medtech/fda-increases-oversight-requirements-for-covid-19-antibody-tests

Also, at this stage a saliva test is likely to be an antigen test rather than antibody, both tests are complimentary and not in direct competition.

Mallys, yes, but that is Avacta's antigen POC saliva test, not in competition with ODX antibody tests. Just trying to clear things up with Safy's earlier post.

Safy, for your benefit, not fake news,straight from the Avacta CEO's mouth yesterday, 54 mins in, within his AGM presentation...
https://webcasting.brrmedia.co.uk/broadcast/5e985bc231da814c9fc6a477/5e9c2239f43115b147000134

Agree DanGo, it won't be Activa antigen test - that will not be available (if successfully developed and approved) until at least mid-summer according to the Avacta CEO. Difficult to imagine it will be an antibody test since a study by the Oxford University COVID19 Evidence Group published on the 7th April did not come across any saliva based POC antibody tests from anyone, anywhere in the world and ceratinly none that were accurate enough, so very unlikely to be anything that has been 'brought in' from outside of the RTC POC group.
https://www.cebm.net/covid-19/molecular-and-antibody-point-of-care-tests-to-support-the-screening-diagnosis-and-monitoring-of-covid-19/
So there is the possibility that the picture you see is not a saliva test or that the RTC POC have pulled a blinder and have successfully developed a saliva based antibody test! I believe have read somewhere that antibodies can be secreted into saliva but I can't find the refernce for that belief just yet.

Dibs, thanks for this. All the pieces of the jigsaw are falling nicely into place and each piece of information links in nicely with other facts and data we have collected and researched.

maqsood.....ODX are making antibody tests, not antigen.

Dibs, I read a couple of things from this BMJ article:
- the source report that the BMJ uses for its article was published on 15th April. This is before the submission of Mologic ELISA test to PHE for approval, so I think that report refers to anitbody tests which the Gov rejected i.e. China tests etc. So I thin time has moved on from that point and Mologic have already stated that their ELISA antibody test meets the MHRA standard.
- although I have always believed that it is incumbent on listed companies to follow regulations and submit a RNS for material news there is also see some latitude between the Gov and the RTC to agree to align and move forward together with news, particularly as it would suit Boris...

....ahhh, Railwayman.....posts 1

I can't find it on Mologic twitter feed either....fake news?

Railwayman, I can't locate this link, could you try and provide the link again please......and this is why Mologic are busy manufacturing ELISA tests (with ODX) and their own RT POC in their own factory?

Lucky, Mologic are not competitors of ODX, they collaborate. I'll repeat the post I made yesterday, this gives you all the information you need.....

ODX is involved on two fronts with Anti-body testing for COVID-19 (to test if someone has had the virus} :
1. Elisa Lab based anti-body testing :
https://mologic.co.uk/covid-19-update-17-april-2020/ - Mologic Update on 17th April- ELISA lab test at least 99% sensitivity, 98% specificity. Independently validated, submitted to PHE for approval. Meets minimum MHRA specification (see MHRA link below). Ignore POC test in this Mologic update, it is for Mologic POC test and not the RTC POC test.
https://mologic.co.uk/mologic-launches-new-lab-based-covid-19-antibody-tests/ - Mologic update on 20th April - MTA with ODX, already in manufacturing, 46000 tests/day production
https://www.lse.co.uk/rns/ODX/covid-19-mta-signed-with-mologic-ltd-chepdhwdztrbaig.html - ODX RNS on 20th April - MTA agreement with Mologic to produce the ELISA lab tests.
https://www.lse.co.uk/rns/ODX/ce-mark-of-covid-19-elisa-antibody-test-i8eaa9hdvc1ezcf.html - ODX RNS on 27th April - ELISA lab test CE mark attained.
Mologic Tweet on 5th May re-confirms ELISA test is already being manufactured as previously notified in Mologic update of 20th April:
“The IgG COVID19 ELISA is the first in a series of diagnostic tests @mologic have developed to support the pandemic response. The ELISA is currently being manufactured with @OmegaDiagnostic and we’re pleased to see its development pathway is now published”.
ELISA test ODX manufacturing news articles:
https://www.ceteris.co.uk/blogs/250-ceteris-work-with-local-companies-in-fight-against-covid-19
https://www.alloaadvertiser.com/news/18426571.alva-firm-joins-uk-rapid-test-consortium/

MHRA specs:
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/881162/Target_Product_Profile_antibody_tests_to_help_determine_if_people_have_immunity_to_SARS-CoV-2_Version_2.pdf

2. Rapid Test Consortium – POC (Point of Care i.e. finger prick blood test) testing:
http://www.omegadiagnostics.com/Portals/0/RNS%20MOU%20on%20COVID-19%20Consortium.pdf
ODX part of RTC to develop and produce POC antibody testing for the masses.
https://www.telegraph.co.uk/news/2020/05/06/coronavirus-covid-antibody-test-home-kit-order/
Government plans for POC testing
Further news articls:
https://www.alloaadvertiser.com/news/18426571.alva-firm-joins-uk-rapid-test-consortium/

Appendix – everything you want to know about COVID-19 testing (lots of it, including antibody testing!) :
https://institute.global/tony-blair/path-mass-testing

I have found this document useful for my own research into COVID-19 testing, fairly easy to understand. Covers both antigen and antibody testing but it helped solidify by conviction with ODX and how it will greatly benefit from the need to manufacture the tests needed for mass antibody testing......

https://institute.global/tony-blair/path-mass-testing

ODX are in a strong position to capitalise on the need for huge amounts of antibody testing as the Gov move us into the 'unlock' phases, so I would say we are just in a Guinness moment, good things come to those who wait....

Eva, RNS link to say ODX are in the RTC :

Rapid Test Consortium – POC (Point of Care i.e. finger prick blood test) testing:

http://www.omegadiagnostics.com/Portals/0/RNS%20MOU%20on%20COVID-19%20Consortium.pdf

ODX are part of RTC to develop and produce POC antibody testing for the masses.