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What a fantastic interview! Removes all doubt that this is going to be anything other than a HUGE success and the way forward for the world to return to normality! (Sorry if this is considered a ramp. It's just enthusiasm based on the extreme cleverness and endearing personality of Big Al.)
@Alltorque - the Analytical validation doesn't establish the clinical Sensitivity and clinical selectivity.
The confusion is that the terms whilst the same mean completely different things. These definitions straight out of the MHRA TPP:
Analytical sensitivity
Sensitivity of a measurement procedure. Quotient of the change in a measurement indication and the corresponding change in a value of a quantity being measured
Analytical specificity
Selectivity of a measurement procedure capability of a measuring system, using a specified measurement procedure, to provide measurement results for one or more measurands which do not depend on each other nor on any other quantity in the system undergoing measurement.
Clinical (Diagnostic) Sensitivity
Ability of an IVD examination procedure to identify the presence of a target marker associated with a particular disease or condition
Clinical (Diagnostic) Specificity
Ability of an IVD examination procedure to recognise the absence of a target marker associated with a particular disease or condition
The above definitions of performance characterisitics taken from BS EN ISO 18113-1:2011, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling): Terms, definitions and general requirements.
Hope this helps
Ophidian
Internal numbers wouldn’t have any credibility, independent clinical validation is needed for approvals.
more experienced posters will likely confirm but I think it's so they don't have to backtrack further down the line incase a tradeoff has to happen on scaling up
To keep this information from all of the potential competitors and Al would rather the clinical validation process confirm the numbers. Wise move.
Because those performance parameters have not yet been clinically validated
Can anyone postulate why the S&S is being kept from the market? Is it to make a bigger splash at a later date? I can see no other reason to withhold it
Alistair made the point that are a multiple near term steps and he’ll keep the market updated. I read that as we can expect several very near term RNSs on the LFT alone. Key stages he highlighted:
- Complete the tech transfer to BBI
- BBI finalise a manufacturing process capable of scaling to millions of tests a month
- BBI produce a pilot batch
- Pass pilot batch over for clinical validation
- Produce further validation batches to show the process is robust and repeatable
- Clinical data in hand, technical file complete
- CE mark product
- Launch product
In addition to those he directly referenced in terms of timeline I’d also add the potential for:
- Additional manufacturers
- Additional clinical validation partners (maybe US?, we have Europe, South America and Africa covered)
- Initial pre orders
- Additional distributors (Medusa is B2C only)
Plus further news on BAMS, neutralising therapy, sewage testing, etc and that’s before even mentioning any of the cancer potential.
I’m expected a very news rich couple of weeks. It would be nice to see each RNS incrementally pushing the SP higher in advance of the big one which has to be the clinical validation.
A few choice quotes from the interview:
‘Working with BBI and Cytiva for the past couple of weeks on technology transfer’ (we’re further ahead than some think)
Interviewer: ‘I assume that means the prototype device developed with Cytiva is actually working well’
Alistair: ‘Yes I’m very pleased indeed.. with the performance of the prototypes... the performance in the lab.. is very good... I’m not going to get into the details as commercially sensitive’ (Alistair previously talked about S&S in the high ‘90’s as being the aspiration, now he’s ‘very pleased indeed’)
‘Worked with BBI over the last couple of weeks to progress the manufacturing process quite drastically’
‘BBI will produce a pilot batch, that can be done quite quickly. Our intention, which is not the norm is to use the pilot batch for clinical validation so that will shortens the overall timeline... we’ll start the clinical validation much sooner that would normally be the case’
‘Very clear stages to go through and we’ll keep the market updated as we hit each of those key milestones’ (numerous positive RNS’s to come)
‘Important to say that we expect the demand for our coronavirus antigen test to be very high indeed So we continue to actively pursue other manufacturerImg partner to ensure we have the capacity to meet that demand’ (BBI are actively scaling to millions of tests a month, it’s clear that will be nowhere near enough)
Very exciting times for all holders. To paraphrase Alistair ‘I’m very pleased indeed with my holding here’
Awesome interview. Basically confirms that we’ve nailed it in the lab. We know the quality Avacta were hoping for and Alistair confirms he’s ‘very happy’ with the performance. I interpret that as specificity and sensitivity in the ‘90’s at least which means once validated by third parties (CONDOR and / or LSTM) the doors are going to blow off here. There won’t be enough manufacturing capacity in the world for a test like this with those levels.
Just watch this interview: https://vimeo.com/445170492