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When I looked at previous WHO approvals it appeared that QMS desk assessment always occurred first, followed by Dossier review completion and approval appeareing around 3 weeks after that. So I am expecting WHO approval to land around about mid-October. The fact that more information had already been requested in the Dossier review hopefully means there will not be too much further delay that (to mid-October).

Directly from communication with GHIF, before they discovered I was reporting some information back on this board and cut my comms (that was unfortunate - lesson learnt).

It also makes sense to me the GHIF need to liquidate some shares in GDR to help preparation of subsidy for sale of GDR tests into the poorer sections of India market.

This was quoted to me back in mid-June....."we think we could recycle our finite amount of capital to both ensure a very significant cashflow for Genedrive, but also the biggest impact."

I am wondering if any RNS around BC/GDR test validation approval will occur in the afternoon, rather than 7am, since BC is listed in NYSE?

yes, just one week away from it being 4 months since the CE Marking of the Genedrive SARS-CoV-2 RT PCR test, so the LTHs here deserve the reward for their patience!!

A couple of key statements for me from today's RNS:

AS did not identify S&S or clinical validation as the key challenge for Avacta's LFT test - "The Affimer reagents that we have generated are very specific to SARS-CoV-2 antigen and we are confident of meeting and exceeding the clinical performance requirements for identifying the most infectious people." He is clearly indicating that the chances of clinical validation success are high - he knows the level that the S&S numbers are likely to be and is expressing confidence to investors.

Rather, Avacta understand the demand for this type of easily self-administered test for mass testing globally meaning that it is the manufacturing of the LFT that is their key focus currently - "Manufacturing capacity is therefore the key challenge that has to be met in achieving widespread roll-out of Avacta's saliva-based rapid antigen test. We therefore continue to actively seek additional manufacturing partners globally to be able to provide the volume of tests that will be required in the UK and elsewhere."
Avacta know the LFT test will succeed and they understand the demand for such a test globally. I expect there are many more manufacturing agreements globally yet to be announced as those manufacturers will know the significance of this kind of test and will want to scramble to participate in its success. Millions of tests per week, even per day, is the potential target for the Avacta LFT self-administered saliva test.

"Dental Life Sciences will be introducing four further tests including a saliva-based test for antigens, later this year".

I expect this to be Avacta's saliva test, no POC test instruments need to be rolled out to Dentists.

https://www.nature.com/articles/s41415-020-2107-4

POC test, there is likely to be some level of trade off between speed and accuracy.

Genedrive have already stated this about their forthcoming POC test.....
"The company’s technical development is on the premise that turnaround times of less than 30 minutes are desirable by end users, and input samples should be easy to obtain from patients (for example, saliva)."

Let's see what they can achieve.

Parkz, yes agreed, Genedrive POC test is going to have a significant impact also, meant to include that in the list so thanks for reminding me.

Waiting for the approvals and news seems to be like waiting for a bus when you need one, none turn up on time, then suddenly they all come along. Could this happen with Genedrive?......

- ICMR/DCGI approval
- FDA EUA approval
- WHO EUA approval
- Africa country approvals
- BC validation and FDA approval
- AIHL autumn launch

.....what are the odds? Which will land first, we need a bookie!

Affimers please.....not Affirmers.

@technik 16.34 post today.....I believe the DCGI is always the final authority for approval of test in India, irrespective of whether the validation tests have been done within India by the ICMR, or whether it is for approval of an FDA approved test. So I don't think that seeing 'DCGI' now assumes that we must be waiting for FDA approval to support India approval. The approval of the ICMR validation tests are still in the pipeline so DCGI could still arrive any day.

I am hoping so as I have been waiting for quite a while like everyone else and my earlier timeline estimates were totally off the mark!

....and in a 2% infection prevalence environment the PPV is much worse, only 14.8% (NPV would be 99.7%). So, a very high level of false positives which would necessitate PCR test confirm all positives.

Plenty of room for Avacta's LFT to beat these figures and based on saliva it will be a no brainer as long as enough Avacta LFT tests can be made to meet what everyone will expect to be very, very high demand!

So, according to AS's performance table, Sona's clinical validation of 85% sensitivity (rounded up) and 90% selectivity put's it in the mid-performance level, with a PPV of 48.6% and NPV of 98.2% within a 10% infection prevalence environment. That's a relatively high number of false positives which isn't too good.

Having looked at WHO EUL status updates since 21st April.......potential indication to look out for :

- QMS desk assessment will normally complete first (diamond triangle)
- followed by Dossier review completion minimum 3-4 weeks after QMS completion, or longer if additional information requested (R status) or follow up amendments requested (F status) during dossier review.

So I am not expecting WHO EUL until latter part of September at the earliest. Any R/F status appearing in dossier review will mean additional week delay, whenever such status appears in any week.

Government has committed today to have the capacity to run 500,0000 Covid-19 tests per day from October. This must be a great opportunity for Genedrive to participate in new contracts for the additional RT-PCR test supply to Gov, as well as displacing some of the current test supply incumbents whose current contracts are up for renewal around that time.

The French health authorities will not directly reimburse the NCYT test because it only looks for a single gene. The GDR test looks for the recommended two genes plus it has integrated RNA control to say if the sample was collected effectively.

Safy, good question but I don't know the answer. However, on the 1st July I was given the impression that the view was 'positive' and the trading update RNS, 9 days later on the 10th July, contained the expression of 'confidence' so doesn't appear to deviate from that impression.

samolly, not sure that's right (check the ICMR archive link below for details) :

25/06/2020 - 133 kits tested, 57 approved.
01/07/2020 - 146 kits tested, 66 approved.
07/07/2020 - 151 kits tested, 68 approved.
10/07/2020 - 154 kits tested, 70 approved.
14/07/2020 - 160 kits tested, 74 approved.

https://www.icmr.gov.in/pdf/covid/kits/archive/

Looks like a rate of ICMR validating about 1.5 tests/day.

Safy, the last I reported for ICMR was that the validation test docs were with the DCGI for review. Unfortunately I cannot give any further update to the status of the ICMR process since apparently I exposed too much on this BB, so that avenue is no longer open to me.

So, lesson to everyone:
- stakeholders can and do read these BBs.
- if you are lucky enough to open an avenue to 'useful' information, then think carefully how you would disclose it to fellow investors, to protect/disguise the source.