Member Info for hants

Hi NDN,

No I didn't watch it - because in all honestly I don't believe that BAMS will move the share price by any significant amount anymore, if at all. 6 months ago yes, but not now. Infact, if a BAMS RNS landed tomorrow it might even cause a share price drop because it's not the borderline overdue LFD news.

The only customer of note for BAMS would be Governments. Our Government is pulling away from lab based testing as we have seen with NCYT. Others will no doubt follow once a good LFT is available.

So no - didn't watch it because I'm no longer interested in that aspect. I can't see it doing much for us anymore. I know lots of people here like to talk about boats and in my opinion that's one which we have indeed missed. All to play for with the LFT though.

The share price rise is on technicals. I see Wyndrum and Bottomzup have been taking a bashing for saying it - but they are exactly right. We've bounced off the 105ema. I think I made a passing mention that it would probably happen in my post of last night too.

It's nothing to do with the BAMS presentation or the Myles tweet.

For those who aren't dismissive of charts and would like to learn, set your chart to 4hour and add in the Exponential Moving Average at 105. You'll note the drop a couple of weeks ago bounces off the 105 EMA, and we've just bounced of it again. Today's move was confirmed by coming out of oversold on the stochastic. Traders piled in and that's why the share price is back up.

Those wishing to bash chartists and traders need to remember they are not the enemy.
-The falling share price has been caused by Avacta holders getting nervous/impatient and selling out.
-The rise has been caused by traders piling in.

Therefore, if it wasn't for the traders/chartists the share price would have continue to drop away. The traders have done us all a massive favour! If it wasn't for them... we would be down another few percent today and probably the same again tomorrow (assuming no news lands).

We all want to see a big rise in the share price on RNS, and it's the traders who will create that rise. I bet nobody on this board will be buying more shares the day the RNS lands - so none of us will be moving the price up!

There's an Avacta presentation a week tomorrow which could also make interesting viewing for ODX holders. It may turn out to be a damp squib, but as news is overdue on many fronts, the results and being delivered 2 months sooner than they need to be and the CEO is doing an investor Q&A through choice - it seems likely that something is going to happen within the next few trading sessions.

It might be the case there's no LFA news and Avacta share price carnage follows, but I can't see they would set themselves up to fail like that. It's possible, but one would certainly hope not!

£5 on CV seems rather ambitious to me! I would say that's mostly priced in already, or was at the higher level. I think that a good CV will take us to all time highs, but probably only £3.

Any sizeable Goverment orders should take us past £5. Exactly where, who knows. It depends on the size/longevity on the tender and how much we are making per test. I'll be dissapointed and surprised if we don't make it past that £5 mark though. We would be most likely be getting media attention by that point, so that should push us north quite rapidly as we saw happen with the Boohoo/Medusa deal last year.

Any other partnerships, manufacturing deals especially elsewhere in the world will have a positive effect. Equally, we could have foreign Governments looking to procure our AffiDX tests too. There's so much left field news which could land out of the blue!

The bed wetting on here is a result of normal share price movements. We will float around this range until something happens. Try to trade it if you want, sit tight, top slice, or take your profits and leave. There's no right or wrong answer.

IMO even if no news lands, the share price will probably bounce regardless either due to technicals or as the antipation builds approaching the presentation, or both.

Our initial data is very good and better than the data which Innova CE marked on using naso swabs. There's a question mark over the SA variant to some degree, but whilst that's new to the UK it's not a new variant - it's been around for months. I would be very surprised if that had been overlooked.

ODX and GAD have been given manufacturing contracts by the Government, plus equipment which currently sits doing nothing - it's not being used to make the Mologic test (of course, their data is okay but not as good as ours).

ODX and GAD can probably make both tests, so I can see why this would have been done. For this reason, I'm not concerned that BBI and Abingdon aren't included currently. If we fail to deliver the goods, that equipment will start churning out Mologic tests instead. (The other possiblity is that it's not us at all, but if not us then who?)

Furthermore, if things were going horribly wrong with our AffiDX test, surely the Goverment would've given up on it, moved and starting making something else instead. You would think so, anyway.

Looking forward to the investor presentation. Only a week to go. Something is going to happen in the next few trading sessions and I can't see it will be anything bad.

Remember to order your Innova tests online. Mine have arrived already and been promptly binned. Unfortunately I had to use an Innova test on Monday working at a college, and will probably have to do another tomorrow. Oddly, it was Innova branded and not NHS branded. The instructions said I had to swab my tonsils (which the NHS branded one doesn't tell you to do) so that was great fun.

Wolves you are exactly correct. I can confirm that is what happened, and some people were apparently crossing the line with the things they were saying.

We know LFT's work and we know Affimers work (best available ELISA). Therefore, it isn't a stretch to beleive that an Affimer LFT will probably work pretty okay too.

I know that. But they're very high profile at the moment with being able to order them to your house etc now.

I've just emailed all the papers/sunday papers about the published Innova tender, the poor real world sensitivity of the tests (with research), and how it's dangerous to have the public confidently thinking they're negative after taking a test with low sensitivity. Would be good to get some publicity on this as it's a totally unacceptable way to spend public funds.

jdt1990, ah good! You believe the same as me then, that Innova is supposed to be a pharyngeal sample.

risk32 - yes I've just read the RNS again and you are correct so well spotted. The general point still stands, though.

If our real world S&S is anywhere near that of the data we've got, we will blow Innova out of the water.

PL this is an interesting point though. The Innova tests are just being used as 'nasal swabs.' Essentially the sampling method described for Innova is exactly the same as what we are expecting our test to be.

I've not been able to find any sources to confirm how they're actually supposed to be used though, and whether their data was based on pharyngeal samples.

I recall that when the Innova tests were first released that they were pharyngeal, but I've not been able to find anything to support this. Of course, this info could have been deliberately buried, because getting school kids and the general public to stick those swabs all the way in just isn't realistic so the Gov have let it slide. I don't know, but I would love to find a source to confirm it.

If that is indeed the case, it would explain why the real world performance of Innova is so poor.

RegulatorUK,

You do understand that Avacta have a test and the initial data was published weeks ago? Furthermore, that data pool was larger than Innova's on which they CE marked and began selling millions? You also understand that data is better than Mologic too (not that it matters as you guys will make whatever is best regardless, or both, so not sure why you're just making stuff up)?

Just because Avacta are doing a thorough clinical evaluation doesn't mean they 'don't have a test.' It means they're making sure the data is solid, which will result in big orders and should also restore public confidence in lateral flow devices - which is good for everybody - including you guys!

Just a little recap on Innova.

Innova CE marked on 25 positive samples and 25 negative. Claim is 96/100 S&S
Avacta's initial evaluation used 30 positive samples and 26 negative. This gave 96.7/100 S&S

So whilst that may not sound exciting, the point is that Innova CE marked on less data than we already have, and the result wasn't actually quite as good either.

Furthermore,
Avacta's samples had CT values of 22-26 (with half them being CT 26) to achieve 96.7%
In the Innova Liverpool pilot, their tests were found to have 79% sensitivity on CT below 20, and 91% on CT below 18.

Innova were achieving a sensitivity of 17% less than Avacta on samples with a much **lower CT value**. Granted this isn't a direct comparison for obvious reasons, but it's interesting!

Further studies of the Innova device on 8774 tests carried out gave an overall S&S of 76.8/99.6, increasing to 95% percent in patients with high viral loads. Sensitivity when used by members of the public dropped to 58%.

What this means in reality:
"A sensitivity of 58% and specificity of 99.6%, this would mean that 100?000 people being tested would find 630 positives—of which only 230 would actually have covid-19, while 400 would be false positives."

Here's some other commentry on the Innvoa Liverpool pilot:

"Indeed it even failed to detect two out of five samples with the highest level of viral gene copies, these displayed a PCR CT of < 20 (i.e. were samples which could be diluted one million fold and still give a positive PCR signal). This graphically shows that this assay is simply not sensitive enough to use to test persons with a view to confirming an absence of infection and thereby an absence of infectivity. A negative result with this lateral flow test simply does not infer an absence of infection.”

"When LFT was compared with PCR, a false positive result occurred in just 2 out of 2981 PCR negative individuals (< 0.1%), but LFT missed 23 of the 35 PCR positive individuals (51%). Because there were only 45 PCR positives in total, there is some uncertainty but the sensitivity of the lateral flow test for SARS Cov-2 judged by PCR is likely to be between 34% and 64%."

"It is not fantastic to see that the sensitivity vs RT-PCR drops below 50%. This low accuracy was mentioned in passing from a guidance document encouraging the use of this product for mass testing programs. This is also rather different to the product instructions stating sensitivity of 96%."

So whats my point? Innova isn't anywhere near as good as their claimed figures from their very limited data. Perhaps Avacta's test won't be as good in the real world either, but the bar is set very low by Innova at the moment!

Sources:
shorturl.at/inyTY
shorturl.at/koGT3
shorturl.at/jBGHK
shorturl.at/dsAJ4

Medusa have updated the page but are still saying it's a saliva test. Very interesting! Maybe the saliva test is still in play even though we have all given up on it?

Or it could just be a massive oversight. Who knows.

Has anybody got a link to the data on which Innova CE marked please? I know it was a very small number of samples but can't find the information.

Retireby40

The Government instructions for the Innova test are as follows:

"Put the swab gently into one nostril, you may feel
a slight resistance (insert about 1.5cm or about half
an inch). Roll the swab 10 times slowly along the
inside of the nostril. Remove the swab and repeat
10 times in the other nostril."

References to it being a nasopharyngeal test appear to have been removed. Equally, it's not described as an anterior test either. They just call it a 'nasal swab.'

To my knowledge, and some googling seems to confirm I'm not going mad, the Innova test was assessed as a nasopharyngeal swab. Nevertheless, it seems to be getting used as if it's an anterior nasal swab and this must surely be resulting in a huge number of false negatives.

I actually had one of these test kits in my hands on Saturday, and the swab is definitely supposed to be nasopharyngeal. It's massive, waaaay too big for a test which is only supposed to go 1.5cm in.

The Gov must surely know that not only are these tests for use on symptomatic individuals, the swabs arent being taken correctly. Unless they're completely stupid (and granted that's certainly a strong possibility based on their track record this far), they'll want to move away from Innova asap.

Will the initially available tests be Innova? In my opinion yes. But hopefully in a few weeks they'll be ours.

Bella, Sir Al has spoken in the past about conducting a 'lay user study' which is the route to marking for consumer use also.

With the Innova tests which the government are distributing to students, teachers etc, the Government have got around it by re branding the tests and creating a new set of instructions. The tests don't come with Innova's instructions. Furthermore, the Innova test is only supposed to be for use in symptomatic individuals.

You couldn't make it up! Destroying public confidence in lateral flows with all this nonsense.

Bella, thats no different to Innova. They are for professional use only.

Sorry, martnotsosmart posted the link! Apologies.

Good find sperenza. Just posting extracts into here for convenience:

Methods We used nasopharyngeal specimens from unexposed asymptomatic individuals to assess five Ag-RDTs: PanBio™ COVID-19 Ag Rapid test (Abbott), CLINITEST® Rapid COVID-19 Antigen Test (Siemens), SARS-CoV-2 Rapid Antigen Test (Roche Diagnostics), SARS-CoV-2 Antigen Rapid Test Kit (Lepu Medical), and COVID-19 Coronavirus Rapid Antigen Test Cassette (Surescreen). Samples were collected between December 2020-January 2021 during the third wave of the epidemic in Spain.

The analysis included 101 specimens with confirmed positive PCR results and 185 with negative PCR. For the overall sample, the performance parameters of Ag-RDTs were as follows: Abbott assay, sensitivity 38·6% (95% CI 29·1–48·8) and specificity 99·5% (97–100%); Siemens, sensitivity 51·5% (41·3–61·6) and specificity 98·4% (95·3–99·6); Roche, sensitivity 43·6% (33·7–53·8) and specificity 96·2% (92·4–98·5); Lepu, sensitivity 45·5% (35·6–55·8) and specificity 89·2% (83·8–93·3%); Surescreen, sensitivity 28·8% (20·2–38·6) and specificity 97·8% (94·5–99·4%). For specimens with cycle threshold (Ct) <30 in RT-qPCR, all Ag-RDT achieved a sensitivity of at least 70%, with Siemens, Roche, and Lepu assays showing sensitivities higher than 80%. In models according to population prevalence, all Ag-RDTs will have a NPV >99% and a PPV<50% at 1% prevalence

It's important to remember at this point the Innova test is not approved for use on asymptomatic individuals. It's actually against the usage instructions... Although the government have got around it by re branding and creating their own, incorrect, instructions.

And obviously the sensitivity is rubbish too.

The million dollar question is who's test will be the new one?

Avacta or...

Mologic
Had a grant from the Gov back in 2020 for development. Plus their spin off manufacturing company, GAD, already have a Gov contract along with Omega. But their test is lower sensitivity than Avacta (based on current data). Also, ODX RNS states the capacity for Gov contract is separate to the Mologic test capacity. Equally, we have access to GAD manufacturing capacity via the Mologic agreement...

Surescreen
Have a contract to make 20 million tests. But two tests per week per adult is well over 100million, so that's leaves a big hole. That's not to say manufacturing capacity couldn't be ramped up, though.

or a competitor we don't know about.

I'm with PL75 that we will sell every test we can make regardless of whether they go to the UK Gov or not. But from a share price perspective, I hope "it's us."