Member Info for beinthelead

Not quite the scardey. The clinical performance of AffiDx is far better. Look at the drop off past 25Ct. It’s dramatic.

They’ll chose either one. If Mologic, good luck. But it will not be a choice based on ensuring the rates of infection is reduced. The best choice for that is Avacta’s. Mologic is a much a higher risk as it’s working at the top of its range at 25 Ct.

Avacta’s is comfortably nailing the infectious range.

The variability in performance has nothing to do with CE.

CE does not inform clinical performance against use case.

CE is not important in how ‘good’ our test is.

CE is a badge that gets stuck on the side of the box to permit sale in Europe and/or UK.

Thanks PAH.

Yes. The Spike is clearly more prevalent in AN samples. Genius move. Others targeting the N were strung along by the ‘less prone the mutations’ risk.

Designed USP or fortunate? I think the former.

Thanks for that. Much better than I could muster! Good read.

Fully support PL. thanks.

The read across note was taken from our business update that stated the lower LOD the better. I’m not comparison is robust, hence the question.

Morning.

Apologies if already posted. Can anyone shed any light on this sensitivity data.

“AffiDX® SARS-CoV-2 Antigen Lateral Flow Test shows excellent analytical sensitivity of 50 pg/ml of S1 spike protein”

Whereas the Mologic test has a LOD of 250 Pfu/ml.

When comparing the two;

“How does this analytical sensitivity translate into pfu/ml of virus which is the clinically relevant measure? Avacta has established this relationship using Avacta’s research ELISA for S1 protein and inactivated virus provided by Public Health England (Porton Down, UK). Using this safe form of the virus, we have shown that an analytical LOD of 50pg/ml corresponds to the amount of S1 spike protein in a virus sample containing 500 pfu/ml.”

Found this study: https://www.medrxiv.org/content/10.1101/2021.03.19.21253950v1.full-text

Correct Ndn. Research proves that using NP as AN significantly reduces the S&S.

The narrative around professional use is also flawed when comparing the two. NP takes more ‘skill’ and is infinitely more complex than AN, in terms of retrieving a consistent sample.

The pivot to AN is driven by sample consistency when used by the layman. I’m convinced the professional use tag will be dropped nearly as quickly as it was applied.

Ray, to add more credibility to your post, you should add clarity on what you perceive the issues to be.

AS was very clear in the RNS and presentation. CE mark to go. Then orders. Mologic have stated their involvement - underpinning AS’s statement.

I’ll reiterate - if we do not get a product to launch in May, we’ve been had by the entire domestic diagnostic industry. There are a few that want Avacta to fail, but this is a stretch.

He/she will be involved in tech file compilation no doubt. Once signed, it’s applied. I’ve said a few times that the CE marking process is a formality and not a lengthy process.

CV is awesome and we’re using standard known components. This is quite simple.

I assume it’s self certified, therefore as soon as the appointed duty holder within Mologic has reviewed the tech file and signed the declaration.

The market makes money. I’d do the same if I were required to make money in such a duplicitous way :)

It’s all logical really. The market has been spooked by AS’s timescales to date. I sympathise and think he’s been heavily constrained by the way.

Having a partner confirm his intentions gives the market some confidence. After all, sentiment til news drives the SP.

Can understand NDN. As you know, we’re in the most de risked position we’ve been in to date, with the share price a fall from previous highs. The market shares your trepidation. Understandable.

I think the money will start coming back this afternoon, into tomorrow. CE will land anytime. I hold no risk with the product, only unknowns over how scaleable the orders are.

I take a lot of confidence from HMG/consortium silence. And AS’s hints about working with the UK. But even more impressed with how he’s conducted his business with EU and ROW.

Commercially, I expect the shackles to come off next week and orders, including licensing, to drive the MCAP. £8 in short order/end of summer is my prediction.

Put it this way; if it fails CE, we’ve been had all along :)

No. The cassette is also known. This is the beauty and risk mitigator in my opinion.

My view, 20p and some stability.

The stability testing is a nothing test. We conduct similar, and usually amounts to subjecting the equipment to cycled temperatures at an increased RH. Done in 24 hours. Print report, pop it in Tech file.

Really is a formality and assume it’s now done.

No problem at all PJ12. It’s not best to convey sarcasm over a BB.

:)

It amazes me how many people are infuriated with making a profit.