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22nd May CE approval. The company would not have known when this would materialise and could not have initiated discussion for approvals until this time. It looks like Indian submission was 2-3 weeks after this. Considering what's needed in terms of discussion (which could not happen before as no CE-IVD approvals were in place), this doesn't seem to be a poor timeline.

We have heard that there was equipment issues in the Indian lab doing the study and this caused a delay in the data being available for approval. Thats now completed and the documentation is going through a the final stage in the process. I should imagine that the department dealing with this are snowed under, plus having to work under semi-lockdown or reduced staffing.

Ahead of any approvals will be a considered view of what studies will be required, what materials are needed, where the testing will take place and shipping of materials, paperwork and discussions with the relevant parties. At which point you make the submission. It simply takes time.

Thanks LTH, doesn’t get better than that, we wait, we sell, we increase market cap

thanks Sattara, it's as expected so thank you for getting clarification.

CE-IVD or US FDA approvals is a prerequisite for Indian approvals unless you do more lengthy approvals in India, ie they take those foreign approvals into account to shorten the process

I look at the sales like this, the main opportunity for the business is one of the larger markets, like south east eases, Africa and the US. Cytiva can only manufacture a certain number. I think GDR are correct holding fire for the larger market opportunities and not selling into non-core markets and risking cannibalise their main markets longer term

Approvals for COVID tests will be given priority thats for sure. There are changes to the CE-IVD process that will make it a much more involved process but I think we are clear of those for the current tests.

I am not sure why the EUA and Indian approvals are taking as long as they are. The manufacturing process means the tests are consistent and robust. The additional software takes the 'human' out of the analysis. It should all be pain sailing so I suspect it's simply down to work load at these approvals centres.

Once approved we should see these do well, what will be interesting is what markets Genedrive focus on. They won't be able to go for every market, even at 10k tests per hour they wouldn't have capacity to sell into say India, US and Brazil. So I suspect we will see them only take one or two large markets and focus their attention on those.

Collection and stability. Normally when you collect a saliva sample the clock is ticking. Saliva contains all sorts of enzymes that are there to start breaking down bits of food you each. It also breaks down bacteria and virus particles over time, its a 'hostile' environment. If you're waiting 24 hours to test a sample the virus has already started to degrade. POC is difference because you are testing within minutes of sampling.

Yes, the aim is its a saliva test with no need for RNA extraction upfront, very neat and a game changer to coin an overused phrase

Worth reading through the Genedrive POC page, we are entering a period where we 'should' get updates about its development as part of any RNS that is put out

As the global spread of coronavirus infection continues, it is likely that a variety of diagnostic tools will be needed for direct clinical care via specialist laboratories, hospitals and in the community.
It is likely that millions of people will continue to need to be monitored and tested, and high accuracy point of care molecular testing in decentralised settings will play an important role.
genedrive will deliver a clinically verified, robust, easy to use assay that can be used on the Genedrive® instrument in decentralised laboratory settings.

Key Design Goals*:

Time to result:, <45 minutes

Point of care, Simple to use assay on maintenance-free, portable and inexpensive Genedrive PCR platform. Rapid results without the need for RNA extraction

Temperature stable reagents, Ambient shipping and storage

Globally accepted gene targets, WHO recommended E and N gene targets

Quality Control, Internal RNA controls to verify reagent integrity, and the presence and quality of the specimen to aid in SARS-COV-2 negative result assignment

Regulatory , Targeting CE-IVD mark

IT, Genedrive® Connect Smartphone connectivity

https://www.genedrive.com/assays/in-development-genedrive-sars-cov-2.php

agree geeforce, or medical AI acquiring businesses like google

woodaldo, the SARS-COV-2 virus is mutating all the time, there now many variants with different different mutations in their sequences. If you only have one target you increase the risk of a mutation occurring in the priming and probing regions of the test. Having 2 or 3 different locations minimises that because of you have a mutation in one, the other is still viable...

One of the key differentiators of the GDR test is that mutations don't throw the test off in the same way that other chemistries do, it's more tolerant to sequence mutations.

no problem.

I think NCYT did what they always do, their research background means that they can quickly get a test out the door day after tomorrow. They've recently moved into the world of clinical approvals, but still think they can develop a test entirely on the computer and rush it out of the door to supply a demand. But with clinical tests you can't. As frustrating as it is to wait for GDR to get through approvals you can rest assured that they will have gone through all the checks and balances to make sure its not prone to the same issues the NCYT test is. It's why they went with a 2 target test in the first place, that was planed and deliberate. NCYT just wanted to get something out the door. Time will tell which model is the correct one, but my money quite literally is on GDR!

@magsy, it's a great question.

Generally you include two targets to improve your chances of obtaining a positive test, your looking for two independent regions. This can be important if the efficiency of your test means that it's prone to inconclusive or indeterminate results.

The literature seems to suggest the NCYT test has been.

This can be down things like mutations in the priming or probing region that throw the efficiency, or carry through of inhibitors from your sample limiting the efficiency of the amplification. By having two independent regions you're minimising those impacts.

Part of the problem with rising out a test is that those factors will not have been taking into account. Primer Design do all of their work up in silico, it's their business model. Whereas companies like GDR go through a careful process of testing against known inhibitors and clinical trials. NCYT won't be able to get away with that second time around, they have to test with real samples so their timelines will be extended.

tighter spread too today which is always encouraging!

https://www.independent.co.uk/news/health/coronavirus-cases-latest-data-global-infection-rate-stats-a9630931.html

The world is on an accelerating rate of infection. Countries coming out of lockdown are seeing second waves. Test and isolate requires everyone to be tested and to isolate, not just those with symptoms - they've already infected others at that stage. Testing everyone means there will be lots of test suppliers. GDR in a good position as are others. The demand is going to be huge for a few years to come... :(

I know people will disagree but I strongly suspect discussions with partners in the background may result in an early sale of the whole business, time will tell.

There is lots in the pipeline being developed, great!

@Andy from that perspective the last few weeks have been good. I don't see the market cap staying at these levels once approvals are in, and I don't see why approvals will not be in shortly given the benefits of the test in all manner of settings... And then to top it all with have true POC, not a repurposed lab instrument, one that the US DOD use out in theatre and the NHS now using to test infants. Truly we are doing really great things here I think.

86.70p ;-D