Gtting additional CE Marking is a normal process followed by many companies to ensure their test is opened up to the widest customer base, particularly of course in Europe. According to Genedrive ......
"It’s very unlikely a customers will run the test if it isn’t CE marked or otherwise approved for their machine. Customer will ALWAYS validate ANY diagnostic test themselves, even if it is CE marked. It’s generally a lab accreditation requirement. The performance of the various PCR platforms in the market is not identical, so the performance of the test is not identical. You will see many companies provide performance data by platform for this reason."
So although the Roche Lightcycler 480 II is a very common PCR machine, it makes total sense to keep opening up the opportunities to customers who may use the ABI 7500 FAST and BioRad CFX96 systems. The fact that even if it is CE marked potential customers will still need to go through their own validation cycle within their own labs, goes some way to explain the length of the time it takes to get to first sales from potential customers.
I had one or two questions on the new Exporter tool, inlcuding if it is actually needed by customers, so I asked Genedrive to clarify. Here is the response I received.....
"It's free and downloaded with a code from our website. It is not mandatory to use but made available as an accessory. It’s much better that the basic software on the PCR machines and we expect most people would want to use it."
So, it was not something that was deliberately 'hidden', or kept secret from earlier sight as being something that was needed to make the test work, it was simply a great idea to further differentiate the better 'simplicity and useability' of the GDR test from others.
"The new Exporter software doesn’t actually run "on" these PCR machines. It just accept the data from them, and so the Exporter sits on any separate PC in the lab, or indeed on the PC for the PCR machine. It needs to be configured for each of the different instrument types as their output files are different formats, and their lasers and detectors they use drive different data ranges. The threshold values to do the interpretation (pos/neg) are derived by running clinical specimens of known type and calibrating the interpretation algorithm."
Disappointment today.....but it can quickly change because the company confidently expects to be 'delivering successful commercial outcomes in the near future', no doubt driven by the ICMR and FDA EUA approvals, which although both have been too long coming, when they do arrive will be the immediate catalysts to drive the all important first significant sales of the PCR test.
So I will patiently wait for the near term........
I have only just been able to catch up on this BB today as have been far too busy this week with 'work'. Can I express my thanks and appreciation to all those who have added new and valuable contributions to the GDR story today, great team work all round.
ST and technick, yes, the links between DIVOC, LHGP, GHIF and Genedrive have been discussed, confirmed and posted before.
I divulged too much previously so not able to get further updates unfortunately. Patience is key, still sipping my guinness....
There is a link between Global Health Investment Fund (GHIF), who now own 13.66% of Genedrive shares, and Dr Kanav Kahol who recently set up DIVOC in India, going as far back as 2013......
Dr Kanav Kahol was from the Public Health Foundation of India at that time. So it doesn't seem to be a a recent 'link up' but something that has likely grown from deeper connections......
At a non-technical 'helicopter level', for the Avacta POC LFT test, the risks and potential impacts in my mind (so imho) are :
1. Avacta, cannot deliver a working product - very low risk on the basis the AS has stated they have a working prototype. On that basis, an LFT should be delivered by the company. High negative impact if the risk materializes, but unlikely in my view.
2. It will not have the level of performance of Sona or other competitor tests - medium/high risk, because nobody knows what the level of performance the Avacta test will reach yet. Low impact because the Avacta test can still be very successful as long as it meets MHRA requirements. AS does seem confident of beating the minimum requirements.
3. It will take longer to pass all validation tests, since it is designed to be taken by a layperson - medium risk on the expectation that anything meant for use by a layperson will have more 'hoops' to jump through. Mitigated to some extent by working with the authorities. Impact is low, as mass screening does need this type of test and if it is delivered in the next market 2-3 months (likely). Any longer than that then impact may rise a little.
4. They cannot manufacture enough to meet demand - medium risk in the short term, but likely reducing over the intermediate term as manufacturing can be scaled up with more partners. Impact low, if Avacta sells all that can be made it will still be good for the SP and will improve over time.
5. More LFT competition arrives - medium risk, as I know of at least 2 other POC LFT antigen tests under development within the boundaries of the UK. Impact, low-medium, as long as Avacta's test meets MHRA requirements (very likely) then there is room in the market for all successful tests.
6. The Covid pandemic subsides - low risk through the next 6-9 months at least, you only have to see the resurgence in some countries and others that haven't even got through the 1st wave yet. Then winter may make matters even worse. Impact would be high but I think this is an unlikely scenario for the next 12 months.
7. A working vaccine is developed - associated with risk no. 6 above. Low risk within the next 6-9 months, probably longer because it does take time to make a safe working vaccine, even when all normal processes are expedited. You cannot short-cut 'safety'. Impact would be high but I think this is an unlikely scenario for the next 12 months.
If you believe risk 1, is low risk (which I do) then an investment in Avacta in the short to intermediate term at least should prove to be a good one.
I believe Avacta will produce their LFT test and will achieve the stated targets that AS mentioned in his video - at least 90% sensitivity and 95% specificity. For me, that will be good enough for the Avacta test to be successful and I believe AS believes that too otherwise he would not have mentioned these targets. It doesn't matter right now what Sona have declared for their test because it still has further validation steps to carry out, the results of these may be better or worse than the 96% they state today.
I would hazard a guess that every component, plastic or chemical, in the Avacta test will be different to the Sona test and even the sample used will be different. Nobody on the bb genuinely knows today if it will be better or worse than Sona's test in performance but not knowing does not matter today. It matters only when Avacta publish their own test performance figures and that they achieve their own target, if they just do that it will be a big win for shareholders.
One of the more interesting points in the SONA announcement was that it seems to be based on a using nasopharyngeal swab, not saliva which Avacta's will use. I think that could prove to be a key advantage of the Avacta POC test, even if AS's target is 90% sensitivity and 95% specificity.
That is probably where Avacta's test will definitely be more suited for the mass 'at home' consumer tests as it is already known that nasopharyngeal swab collection done by a layperson can be incorrectly done 30% of the time.
So, I don't think Avacta's test even needs to match the 96% S&S of Sona's test, 90%/95% S&S in Avacta's test will be good enough for mass screen testing as it is likely to be more reliable in the hands of a layperson.
Safy, it was confirmed to me by Lions Head Global Partners they are legit when I asked them about DIVOC's direct partnership reference to LHGP on the DIVOC website. No harm in getting it re-confirmed again by Genedrive though.
Safy, to exactly quote from my source....."My guys remain positive on the basis that they got the testing done very quickly, which either means we absolutely crashed or we flew through. Given our belief in the test we are telling ourselves that it is the latter."
With previous feedback reported by DB from other potential customers we have no reason to believe anything other than success, but until the fat lady sings etc......
Safy, yes, the Genedrive SARS-Cov-2 PCR test kit has been put through its paces by ICMR/DCGI with the intention to gain specific approval by the Indian authorities. The execution of test validation has been completed - the data and docs from that are currently with DCGI as I previously reported.
Newbie111, I am in email exchange with a stakeholder whose team have been directly involved in this process (not Genedrive). I previously reported that they were delayed because the India Govt testing machine broke. Take it, or leave it but I only report from credible sources and facts.
This is the latest information I have on India approval progress....
- the validation testing is complete
- the docs are with Drug Controller General of India (DCGI) now
- but then the DCGI closed for a 2 day deep clean after a group of employees got covid!
So timing is in the hands of the Indians right now, but logic would suggest that it is imminent (bar anymore Covid!)