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There are quite a few in development out there Timster. Tip of the iceberg as LFT tech is well established, everyone is now trying to work out how to get a test that 'works', including some of the big diagnostic players. They all know there is a large potential market here. I'm not worried about competition from the smaller players, but when the larger players bring their versions to market, they will be well placed to cause a splash. I'd like to hear Avacta talk more to their commercial strategy soon e.g. public screening vs. commercial/private/corporate market so we get a better idea on forecasts.
Thanks for the article tomvisual. It's an interesting piece of work, but only focusses on one aspect of the potential immunological response to Sars-Cov2, that of neurtralising antibodies. Whilst the focus on nAbs may be the first thought to fight the infection and indeed the potential preventative approach afforded by certain vaccine development (as well as re-infection), it does not tell the full story.
We do not understand the full cellular and humoral response to Sars-Cov-2 at this stage, a more fuller report (and this may be in the article when published) would be to see the range of immune responses to infection. It has been observed in previous coronavirus infections that the immune response goes beyond just that of nAbs. So far, from the research to date, we have seen that the Inovio vaccine seems to produce a T and B cell response from Phase I studies, although details are scarce at this stage. In addition, from other Phase I studies, the levels of anitibody responses have been at much higher magnitudes than that observed in patients with infections. Clearly, more data is required as to whether the vaccines confer any immunity, but we don't have the full picture yet.
I would have liked to have seen more balanced reporting from the media, rather than immune response lost in months - we just don't know if that's the case.
In the short term (certainly the next 2 years) I can see testing being pivotal to day to day life, even if a vaccine were to work, and with the timescales being purported by some manufacturers and politicians, it would probably take a year to vaccinate a population of a country the size of the UK and then we wouldn't know how long any immunity offered by a vaccine would confer. Certainly not from interim data, and so testing and vaccines may well co-exist for a while yet, until we know more about the entire immune response.
It's a very positive RNS. From a company that was trading in single digit millions in revenues to at end of year will be in the hundreds of millions shows the progress as well as the potential. Not only are the company going to continue to increase revenues in existing markets, but they are now targeting other lucrative markets e.g. USA. The RNS was carefully worded around the USA, which is difficult to break into and working with a distributer partner will make all the difference and add value again when taking on established players like Quidel and Chembio
Outside of the USA, Novacyt are the yardstick for COVID-19 dia stocks and are setting a good bar.
Bit of an Oxford love in, but I think they've messaged this well. An in-community use RT-LAMP test that should cost no more than 20GBP with great spef and sens. They're light on the details like, how easy is it to use a test that still relies on swabs being taken, in the community setting, if the validation work was done in the hospital setting, and what does great spef and sens mean exactly. Being able to conduct the test at RT and 30-45 mins turnaround time are all good.
Their messaging around being able to free economic recovery are good.
https://www.ox.ac.uk/news/2020-07-08-oxford-scientists-form-spinout-launch-rapid-covid-19-virus-test?utm_source=miragenews&utm_medium=miragenews&utm_campaign=news
Paves the way for the Avacta test, less liable to sampling errors (saliva), RT use, and 15 mins turnaround, if it matches the "great spef and sens", it'll easily replace this Oxford test/out compete as something that can be widely used in the community.
In the early days, EUAs were being given on the basis of minimal validation, but the FDA have been raising the bar since stories of a number of assays just not performing in practice. I still think it's ridiculously quick, a matter of a few weeks. BD had between 200-300 clinical samples as part of their validation work, working on the tech to get to a stage of validation is what takes time.
Not a direct competitor to the Avacta test, but interesting to see the hospital use BD antigen rapid POC test receiving FDA EUA based on 84% sensitivity. They're aiming to produce up to 2 mil tests/week with each test at $20 each.
The Avacta proposition will be different, and for me shows the market is more than large enough market for multiple players, each offering different rapid POC tech for different end users.
https://www.bnnbloomberg.ca/becton-dickinson-wins-fda-approval-of-15-minute-hand-held-covid-test-1.1461069
Interesting read CO, thanks for sharing. This is the article I found in The Lancet.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30113-4/fulltext
Figure D being the one you want. The R2 values start at 0.5 and go to 0.95 (all stat sig) depending on days after exposure. In short, it gives me confidence the test will be of good utility at min TPP.
If I read Ophidian's question correctly, and asking about viral load required to infect, it is a good question. I'm not sure that can be answered at the moment, given the number of host variables e.g. age, gender, presence and number of co-morbidities, immunocompetence etc. Compared to what we have now, which are blunt tools of lockdown/no lockdown and isolate entire populations, I can see this test offering a more sophisticated approach. Those working for the government's test and trace scheme should be looking into how to incorporate this test into the system. It would enable them to do what they are looking to do - operate a more normal economy whilst this pandemic predominates.
Nice summary CO. I was also looking at this topic and found another pub in The Lancet showing a nice correlation between oropharyngeal swab and saliva samples in one cohort; there was one pre-sym patient who had a value of 647 copies/ml. Part of the problem, as you say is the small sample size in each of the reported cohorts and trying to make sense of each of them. Needless to say, pre-sym, asym and syms all produce viral loads which increase over the first few days of infection.
Having thought about this, and again looking at the bigger picture, even if the company have a test that meets the minimal TPP, it will be such a game changer compared to what we have right now. They're definitely doing the right thing by optimising the asset, but I think anything that meets min TPP will be in great demand. I'd like to see the company talk more about supply chain and commercial strategy now. For me, there's a big question on how to meet the demand and how to commercialise successfully.
The next couple of months will be telling. All of the early vaccine manufacturers will report results of their Phase I studies and from the reporting, I take it that AZ will have an interim on their Phase II/III study some time in the summer. If most/all of these demonstrate a strong antibody involvement and can start (and I emphasise start) to show immune responses, then the utility of any antibody test increases significantly. There are many unknowns still e.g. what antibodies are involved in immunity, how long does the immunity last, what other immune cells confer immunity etc.
Along with the ongoing longitudinal serological studies, we shall start to place the pieces of this jigsaw together.
With the impending data from the vaccine studies, I can only see the demand increasing for antibody tests.
@ophidian - I managed to get a little time to search and didn’t find anything much more than you did. There was another publication in The Lancet demonstrating pre-symptomatic sputum levels a day before onset generally resembled levels of the post-symptomatics, with the exception of one sample at 641 copies per mL. The limitations of the research being the small sample sizes (inherent variability) and little information on the clinical severity of the infections that pursued those who gave samples. I couldn’t find the article you mentioned about the zika affimer anywhere, do you have a citation or a link? There also appears to be very little published on the use of affimers in the clinical context, not unsurprising given the early stage of the tech.
Based on the available evidence, I’m inclined to think they will aim this test at the symptomatics and the assymptomatics, whilst build the evidence base for the pre-symptomatics. If your calculation on the LoD is reflective of the profile of the test kit, and if you’ve based that on the presence of zika in saliva, where zika is not thought to be a respiratory pathogen, then it gives me greater confidence to consider the affimer technology to detect a respiratory pathogen epitope with sufficient sensitivity to detect infected patients within a couple of days of exposure. Clearly, the clinical validation will tell us more. Such a proposition of being able to quickly identify assmyptomatic and symptomatics cases quickly, in itself would be phenomenal, and allow many businesses to run like normal, where they can’t do so now and travel to take place with much more confidence to name a few areas to benefit.
The next stage would be to also prove use in detecting pre-syms. For me, a useful study would involve the test, track and isolate setting, where if one identifies reference symptomatic cases, and then in a longitudinal fashion repeatedly test contacts over a 15 day period, with both the nasopharyngeal swab and affimer saliva test kit, and track the development and severity of symptoms in all the contact cases. Then identify the pre-symptomatic cohort and determine whether the utility of the affimer test could be extended to pre-symptomatic cases.
Looking forward to the testing of clinical samples, the market for assymptomatics as well as symptomatics will be large, be it use in the private/commercial +/-NHS/healthcare setting. The additional of pre-syms would give the added benefit particularly from a public health perspective of driving down case spread even further.
https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30113-4/fulltext
Many thanks Ophidian, I'll look up the post - you'll have saved me a lit search on a Friday :-). If I get time to do an updated search and find anything, I'll share it.
It will be interesting to know what recommendations will be placed on when to take the test, relative to the time of suspected exposure of the virus, in order to detect a 'true' result. I'm excited by the prospect of a point of care test that will enable us to live more normally than we are right now. I assume that the target profile of the test is such that it would enable detection of infection in symptomatic individuals as well as assymptomatic individuals who have been exposed for a couple of days. If the test is also being targeted to detect virus at levels before manifest clinical symptoms (pre-symptomatic), universal testing could be called for and consequently many individuals could live near normal lives. In any case, this innovation could transform how we live right now and I'm excited to learn more about the prospects of using it in the different patient types. Well done to the company for getting this far and look forward to the next news.
Thanks Pl75, I mentioned it yesterday. I’m inclined to agree, but it would be reassuring to see a roadmap to launch from the company, highlighting this important validation step on the journey. I’ve confidence in the test, and we’ve all observed how the various antibody tests have fallen short of the mark once they were independently tested.
In any normal development cycle, this sort of testing would be built in. For universal acceptance in the current climate, validation via CONDOR is essential. It would be the equivalent of a NICE recommendation for a new drug to be used by the nhs and will strongly drive demand.
Has any information been posted about whether Avavta have signed up to have their test evaluated on the CONDOR platform?
Maybe it is a little early, as proof of concept has just passed, but I suspect CONDOR will be the route to market for all of these tests now.