Member Info for tkevin

ooks like someone else got out first. In any case, the clinical sensitivity is shockingly poor. I can’t see this getting much traction, but I suppose people will use anything right now. On the positive, looks like getting emergency FDA is pretty easy.

Quidel Receives First FDA Emergency Use Authorization for Rapid POC Antigen Test

NEW YORK – The US Food and Drug Administration on Friday granted Emergency Use Authorization for Quidel's Sofia 2 SARS Antigen FIA, a rapid point-of-care test for the detection of the novel coronavirus.

The test is the first protein-based antigen test to receive EUA from the FDA and is for the qualitative detection of a nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal and nasal swab specimens. Tests that previously received FDA EUAs are either molecular, detecting viral nucleic acid, or serology tests that detect antibodies to the coronavirus.

Rapid antigen tests can be a new strategy in the fight against COVID-19. Compared to PCR tests, which can take about a day for results, Quidel's antigen test provides results in about 15 minutes. Historically, though, antigen tests for flus and other ailments have not been as accurate as molecular tests.

In its instructions for use for the Sofia 2 SARS Antigen FIA test, Quidel said that the test demonstrated 80 percent clinical sensitivity compared to an EUA molecular device and clinical specificity of 100 percent.

"The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for COVID-19 diagnosis, accelerating the time to diagnosis and potential treatment of COVID-19 for the patient," Quidel President and CEO Douglas Bryant said in a statement.

Existing shareholders have pre-emption rights, and there are a lot of existing holders that have been with the company for years. I suspect if you’re not already a holder, you'll get nothing, irrespective of how much you ask for.

the mother of all tree shakes.

I know this is based of a hospital lab test, and Omega is also working on a point of care community test, so not too damaging I hope. This can't be a positive development for the Omega/Mologic tie up though. High throughput lab automated test from Roche vs a manual Elisa test from Mologic . Roche is a proper diagnostic company and product has now been approved by the FDA - the first antibody test approved there. The race continues for community test though.

Problem is 4 companies everyday announce a new ‘breakthrough’ test, therapy, vaccine, and so one. The world is full of ideas but getting products that work and are safe is a different matter. The article says in one place it will be cleared by the FDA in May, and then in another it says “ we don’t even know if it works in COVID 19”. And it’s in The Guardian.

Most people here seem to get their schooling from reading a toilet wall. Shocking lack of understanding of basic science and basic test development.

Hopes for the discovery of a ‘game changing’ immunity test for Covid-19 were dealt a new blow on Sunday when the Government was forced to deny claims it had ordered up to 50 million home testing kits.

https://www.telegraph.co.uk/news/2020/04/26/game-changing-oxford-antibody-test-claims-overblown/

But it never happened.

“ The group intends to commercialise Affimer-based rapid diagnostics through codevelopment and licensing to third party diagnostics developers....”

I posted similar on the Avacta board but didn’t get much there and they just ignored me because they thought I was raining on their parade. Despite the fact that I couldnt find anything on Affimers ever being used in a diagnostic product, important markets like the FDA ONLY offer emergency use authorisation for the technologies they accept - PCR and antibodies ( and says on the FDA website they believe antibody tests to be of little use). So they would probably have to go through standard. FDA PMA approval processes that would take year(s). Anyway, this isn’t an Avacta board so my apologies.

Antibody tests are an accepted known technology. Affimers have never been used in a diagnostic device, so aren’t proven. People post this reference to Affimers and Zika. Might have been a great idea but they were never actually used in a product.

That’s a very pro Avacta reply, but I’ll go back to my earlier questions to state that even if Avacta can make a product that works, and that is a solid “if”, they are a long way from commercialising. New technologies don’t qualify for emergency use authorisations, so they would have to go through standard approval processes, and would take 6 months at least, and years for FDA. If Oxford already had an antibody test that works, you can bet dozens more will come out in that time. Whether people have immunity with antibodies will now emerge with time.

The DM reports UK gov now ordered 50 million antibody tests that have now been proven to work https://www.dailymail.co.uk/news/article-8257233/Government-orders-50million-game-changing-immunity-tests.html

Antibodies, nor Affimers used in lateral flow devices. Still can’t see that these Have ever actually been use in a product. It’s theoretically ok I suppose but makes the likelihood of success more questionable.

Sorry, I asked this earlier but was lost in the threads of mindless pumpers. Have Affimers ever been used in a diagnostic device? I see on the AVCT website that they developed Affimers for Zika virus, but were they used for diagnostic use? I have never heard of Affimers until the Cytiva RNS as I wasn’t following the company. Andif they did work, what would be the regulatory consequence if a technology never used before? I thing the answer to the first part is “no”, and the second part would mean they would never qualify for emergency use authorisation. That’s only for existing technologies. They could be years/12 month from being able to sell?

But have Affimers ever been used in a diagnostic device? I see on the AVCT website that they developed Affimers for Zika virus, but were they used for diagnostic use? I have never heard of Affimers until the Cytiva RNS as I wasn’t following the company. Sorry for the newbie Q.

Suggests that tests from commercial source where the testing laboratory doesn’t have to “chef” the test together first are better.

https://www.telegraph.co.uk/news/2020/04/21/public-health-england-admits-coronavirus-tests-used-send-nhs/

Can do it in a research lab.

But apparently lots of people that have have coronavirus have no antibodies, so what good is an antibody test even for epidemiological reasons?

Correction - I misunderstood the terminology. By “antigen” they mean directly testing what causes the infection ( virus) as opposed to secondary respond to the infection ( antibody). Do agree that antigen is more relevant right now.

That ABPI link called molecular testing “antigen testing”. I don’t think that’s correct. Antibodies and antigens are proteins that get done with serology or lateral flow tests? Molecular tests are looking for genetic sequences.