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LW
Ecolog was the company - settled for £38.4 mill in relation to RT -PCR testing services not taken up by DHSC
Kaeren
Wren Laboratories - Branford Connecticut. Established 2014
Wren Labs UK established 2004 and controlled by holding company Medipharma Ltd from 2016. No common officers that I can see or links . No hints.
Well it certainly says that on the web page so who am I to argue?
I'm just relating what I was told and then checked the partnership on NPH's web site which said Yourgene.
Happy to be proved wrong though
Hi Kitzie - Nuffield for who (or where) ?
*MD N A Life Sciences - that wasn't a freudian slip!
Newcastle airport use two local testing companies - MDMA Life Sciences (don't know where they source the test from) and NPH Group - who use Yourgene
Sunday Times:".....Innova Medical Group, said the UK was his biggest customer, with hundreds of millions of tests already delivered and a total of one billion expected by the middle of next month........Under the Operation Moonshot strategy, the government plans to use targeted mass testing in the public sector to monitor infection rates and stop asymptomatic spread."
Whilst this seems to provide some impetus for LFT supply (of course, it does in the short term) what follows and is linked to LFT is the PCR test. There is no doubt that there is insufficient PCR capacity to carry out the number of covid tests that the UK wishes to undertake in order to provide reassurance and to support the return to normal activity. But expand LFTs and you are inherently expanding the overall test regime that includes PCR-related companies, so NCYT are there .
If decisions are made to move away from LFTs then the options are LAMP and PCR - and the quicker and more accurate the alternatives can be will decide the next move. Both of these are NCYT.
As the effect of vaccines develop and questions about immunity come through then a test for antibody levels for research and community diagnostics are becoming more important - and NCYT are there also.
Finally, I'd pose a question about LFTs - putting aside the accuracy associated with sampling practice, then exactly why are they being justified as appropriate for indicating asymptomatic carriers? I am not sure about the level of virus that a patient has to carry in order to be infectious, but I do know that LFTs only detect relatively high viral loads (at approx 25+ PCR cycles). So, if patients are asymptomatic - do they carry a low viral load or does their existing immune system deal with the infection caused? If they are asymptomatic because they only carry a low load then there's a problem with the clinical justification for LFTs...
Upper respiratory tract is basically the head (eg sinuses), back of throat and trachea.
Lower tract is effectively the body of the lungs - ie the fine tubes that run from the windpipe into the sacs that exchange oxygen /CO2 with the bloodstream.
So testing for the lower tract is rather invasive and easier to undertake when on a ventilator. In the case that you're talking about - yes evidently done post mortem and as part of an investigation into cause.
ShaunP
Thanks for the pointer to the dropbox. I had reviewed your financials some considerable time ago but have never had the time to update myself. Really impressive - I know there are a lot of good researchers on this board - and I'll try to contribute when I can. Not always handy though.
Will keep an eye out for the LAMP announcement as it will b interesting to see if it has any similarities to the current one being looked at by HMG
Hartlebury - whilst I'll defer to Wbernard if he thinks differently, my thoughts on LFTs are that there this no clear need to develop them to achieve the performance of PCR (even if that was possible). The UK gvt are only using them to address the public perception of testing capacity (ie to achieve large volumes at low cost and, at best, medium performance) and I believe the industry is working on enhancing PCR and developing LAMP. I cannot see a lot of time being dedicated to LFD (device) development by NCYT or other major players. I know the Gvt are looking to enhance UK LFD provision but I'm not convinced its worthwhile given it's limitations - the only benefit is that it should establish UK manufacturers and remove the costs and doubts associated with importing them.
NCYT needs to continue to lead the field and doesn't need to join the chasing pack - there's too many of them.
Thanks for that. The results will be important, whichever way they go.
I think it is too early to be used for community testing and would need regulatory approval first. Whilst the idea is to genotype the 'surge' samples I'd guess they are using the central labs for that as they haven't had much time to set things up in terms of volume - remember the labs are also taking the diagnostic clinical samples from urgent care . Doesn't stop them separating samples and running them as part of validation if they can obtain permission. The Company are saying they can use the Q16 and 32's , but that's maybe a step too far at present. Timescales are not yet clear for introduction.
Hartlebury - thanks . The use of the proposed assay will make it quick and (relatively) easy to identify the variants - a benefit if their significance develops but is currently RUO until it gets approval. It will also enable the identification of further variants but of course this depends upon the appropriate samples being caught by the testing system. Whatever analysis is used, the sampling regime needs to give us a realistic probability of picking up infections associated with variants - so how is that done? by statistical methods or by physical diagnosis. Once the presence of a variant is known and its distribution then that makes it easier of course. The point in terms of the present testing regime is that LFTs just indicate if you have a widespread hidden infection across the community (we'll park the issue of accuracy etc for the time being), but you still need PCR and any new specific identifying assay to confirm the variant. So all this talk about how widespread the UK variant or SA variant is must be based on analysis utilising anything other than LFT. It's like putting a stick into a frozen lollipop mould - you don't really know what flavour it is until you test er taste it ..... sorry I like my analogies (even if they can be quite poor at times)
Oh and yes I see no reason why the new assay cannot be used to identify any variant of a similar character. Genotyping is used widely. But we'll have to see what it entails.
Sorry I'm late but can I contribute :
LFTs utilise an antibody or label molecule to bind to the protein in the outer membrane of the virus particle (the spike). This then presents in the device as a colour change as it moves along the pad. I gather it's possible to quantify the level of virus but LFT is an indicator and is not an identifier. It is also best with high virus loads - you'll see that Gvt guidance accepts that LFTs are intended to find as many symptomless carriers as possible, rather than to confirm infection. That's not generally understood by the public I suggest.
PCR of what ever type (there are several variations) will look for specific proteins (eg the S protein) to confirm the presence of the virus. I think there are three specific to covid 19. The process is more intensive as it amplifies the DNA or RNA within the virus particle and is more sensitive. It is used as a diagnostic test for infected patients to confirm presence of the virus even after the infectious period.
Genetic sequencing is the best way to identify each variant.
Worthwhile pointing out therefore that regardless of the number of LFTs being used, they can only confirm the presence of the virus and CANNOT distinguish between variants. So the new variants are being identified in labs by PCR I presume. HOWEVER I'd remind you that NCYT RNS of 2 Feb has just confirmed that " The SNPsig® assays offer the ability to track variants on-site and to generate a result in hours, compared to the current approach of next generation sequencing, which is typically constrained by limited capacity, cost and an off-site multi-day turnaround." That puts the company way ahead of the rest of the field.
As a final point the UK Gvt are looking at a more sensitive and accurate replacement for LFTs - ie LAMPpore - and if I also recall correctly NCYT are intending to produce a LAMP assay in Q1 also. All of this shows exactly why I'm invested in this company who (to use a horse racing analogy) are leading the field to such an extent that when a fence suddenly appears, they are already in the process of jumping, whilst the rest of the field are running like mad to get to the first hurdle before it develops into Becher's Brook!
Apologies if I'm telling you what you already know ..
RUO kits for research use only Easy = 50 reaction kit (Q16) and Std = 150
CE IVD - Euro approved for in vitro (in a test tube/lab environment)
US - FDA approved - separately identified to ensure traceability for US purposes, and the validation process is more intense and likely more documented.
The CE Mark in the European Union and the FDA-approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices. FDA approval, however, is significantly more expensive to obtain for a number of reasons:
1. The documentation required from investigators is much less efficient for FDA submissions than it is for the CE Mark.
2. The review cycle is about three times longer with the FDA.
3. There are almost always more rounds of questions with FDA-approval submissions than with those for CE Mark.
FDA approval always requires a full clinical trial or trials, whereas the CE Mark can be obtained through a clinical evaluation—a review of published data for existing equivalent devices. For a clinical evaluation, the only requirement is that the manufacturer conduct a postmarket clinical follow-up study once the CE Mark is obtained. However, this type of study is much easier to get approval for and therefore much less expensive to conduct than a clinical trial
The US will not normally accept a device that is only CE marked. However some countries (outside the EU) will accept US FDA approval
I spotted a company advertising exactly that - surface testing for Covid-19. They're based near Stafford and Bellshill (North Lanarkshire). Seems a logical progression for decontaminating areas and other surfaces. I'm sure it will come, as cleaning companies have to rely on ATP indicative testing for assessing success of cleaning regimes.
Yes, London Stock Exchange site shows an extra seven trades ending with the 2.00p one for 250k.
Oops ! … and not Arrow either !