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@Trickymatters: I believe the bid stat contract you are referring to is the one awarded to Royal Mail on 3 July 2021, for £279 million. This is linked to NHS Test and Trace so will be for LFTs.
https://bidstats.uk/tenders/2021/W26/754057219
Under the successful PHE Framework contract award our products included are : 96 SARS-CoV-2 Kit, HCV ID Kit and MT-RNR1 ID Kit. (Source: https://www.lse.co.uk/rns/GDR/phe-national-framework-agreement-211uryfthovy4e9.html)
Our PoC product is not included as of now, as products had to be CE marked to be considered. HOWEVER, as stated on the PHE Contract Award Notice: "...successful Suppliers will be able to propose new and/or updated Goods and/or Services to be added to a Supplier’s range under the Framework Agreement ..." based on certain criteria.
(Source: https://bidstats.uk/tenders/2021/W15/748945953)
Our PoC is a very unique product in the market and under the framework, we are open to many division within the public healtcare system.
"The framework is intended to be accessed by: Public Health England; Department of Health and Social Care; Public Health Wales; Public Health Scotland; Department for Health for Northern Ireland; Health and Social Care Northern Ireland; NHS Authorities, NHS Trusts, NHS Foundation Trusts, Special Health Authorities, NHS Scotland Health Boards, NHS Wales Health Boards, NHS Northern Ireland Health Boards, Special NHS Boards and any other NHS entity; Local Authorities; any other bodies governed by public law (as defined in regulation 2 of the Public Contracts Regulations 2015 (SI 2015/102) (as amended); and academic or charitable institutions (including any such institutions that are not Contracting Authorities)."
(Source: https://bidstats.uk/tenders/2021/W15/748945953)
This being said, I believe having the PoC assessed in an independent UK Public Health England laboratory can only be described as a positive move from GDR for inclusion in the framework, as it gives PHE the ability to directly assess our product and puts our product front and center with PHE.
Yes, WHO have been surprisingly slow.
Its the FDA I almost feel lost for words but I have a very strong suspicion that politics is at play. The fact that we did not apply in partnership with BC or any other US company could be the politics I refer to. Considering our test has been proven to be best in class via clinical, real life trials and case studies as well as country specific authorisation findings, and the FDA did say they were prioritising multi-analyte, lower waste and high-throughput, then WHY DO WE STILL WAIT ON EUA????
Trickymatters: WHO is extremely slow such that on 19 Jan 2021, we were at the same exact stage
QMS Desk Assessment = COMPLETED and Dossier review = IN PROCESS.
Yes we take some +ve from the fact that they came back asking for info 3 weeks ago and now we are back in the IN PROCESS stage.
@Blueocean: the actual genedrive device was designed to be a one-stop shop for decentralised testing. All of the assays (except the SARS-CoV-2) are designed to work on the genedrive device: COV19-ID (launching soon), HCV, MR-RNR1, Military and the mTB (in development).
This very design spec is what gives it a competitive edge.
https://www.genedrive.com/genedrive-system/overview.php
@Blueocean: regarding sustainability, I'm not sure the POC does make a major improvement compared to LFT (unlike our PCR test and its 1-step process compared to other PCR tests). Our POC still requires nasal swab, sample collection tube - incl. buffer and dispensing cap, and assay cartridge.
This is always going to be a limitation for rapid point of care testing - unless a simple paper strip test is developed at some point for example.
That being said, our POC is quite an achievement that surpasses the competition in terms of rigour (2-gene target with all VOCs inclusive), bio-safety, ease of operation and accuracy.
This one? http://www.genedriveplc.com/investor-relations/index.php
@Hendi2 - I noticed a few vague and possibly inaccurate points in your last post, which I would like to address for clarity:
1) The 400k sales/order was related to Beckman Coulter and the PCR tests, not Mountain Horse
2) Where did you come up with "market for the US Military is 456k"? Not sure such a valuation is even possible. I also believe the Genedrive® BioPlex Pathogen Detection (Military) is a US DoD exclusive assay at the moment. That being said there is US DoD budget proposals for between 100-150 orders of the genedrive device which will thus drive a significant order for the assays
3) CE marking is not driven by an accreditation body. Its an EU self-certification directive, whereby the manufacturer bears sole responsibility for declaring conformity with all EU requirements. So the only timescales for this is set and controlled by genedrive themselves.
Thanks Inphobe for adding this.
And yes one very key difference to NCYT, is that these tests can run on various platforms, thereby increasing the customer base with already established lab equipment
- ABI 7500 Fast
- Roche LightCycler® 480 II
- Bio-Rad CFX96
Genedrive 96 SARS COV-2 Kit is being sold via Beckman Coulter in the US, UK and EU bet. £15-18 per test (in packages of 960 test, split in 10 pouches)
The major advantage of the kit:
1) Solid PCR bead format + simple 1-step process – eliminates the need for time-consuming and error-prone reagent preparation
2) Lyophilised reagents – stored at ambient storage (2-30°C) allowing for immediate use, no need for thawing reagents.
3) High volume manufacturing capabilities – meet global test demands >10,000 tests/hour
Longrun, appreciate this information. I accept their were duty bound, but what troubles me is the subjective viewing of what is price sensitive and whats not.
1) My argument is if you can RNS individual country approvals e.g. South Africa and India, why do you not RNS import licence approvals? Approvals and import licences are not of value without the each other, therefore it implies they hold the same significance.
2) While they may say they are protecting investors, they also failed to provide adequate insight into how they were working to address the issue of price controls - which fro one is related to public testing not private.
3) Now I also ask if there are sharp drops, why is the reaction not the same? Maybe someone has an answer for this one, but surely you have to protect investors in either direction of share price movement.
@serendipity: This is a DoD Budget document. It is simply a plan for their expenditures and justification for these expenses. Budgets have to be approved before any procurement takes place. But its still a good sign for GDR with a revenue stream.
@Invest4theLT: yeah, it's strange behaviour from Walbrook. I was getting replies from them earlier this month and just in the last 7-10 days = no replies. So I don't think you asked the wrong question, it looks like someone has been silenced to buy time.
Would be interested to know opinions on what is currently happening: depressed news flow, quick reactionary responses framed in a way to dampen sentiment and silence from Walbrook for many over the last week.
All as we approach the end of Q2 (which was meant to have some updates).
Trickymatters, I'm not sure how many times we have to say GDR already have full access to the EU via the CE mark since May 2020. READ the RNS: https://www.lse.co.uk/rns/GDR/genedrive-96-sars-cov-2-kit-receives-ce-ivd-mark-gy5g0vm7nhxxeub.html
I have been in GDR for more than 15 months and can say we have been ont he WHO list since middle of last year. WHO never had loads of PCR test approvals - you can confirm this by the number they have approved. They are just not putting much resources to test approvals as it does not necessarily bring anything major. The big markets - US, UK, EU, India all have their respective approval procedures and regulators. Ad they only update every Tuesday/ Wednesday so you will not get any more info until next week - unless we get an RNS.
Trickymatters - EU approval is already achieved since May 2020 with our CE mark status - this is all that is required to sell into all of the EU. Its on this basis we have been in discussions with an EU MoH for example (though it seems to be a dead horse customer right now) and why Beckman is our distributor into the EU.
WHO application has been in since the middle of 2020. Its too slow of a process - appears that WHO had less resources focused on the testing side as opposed to vaccine side of approvals. You can tell by how many approvals were processed on a monthly basis and the last PCR test approved in Dec 2020.
Roger65: this scenario has been a strong possibility to me for a while now.
1) Walbrook confirming to me and others that GDR has been in a closed position since last summer.
2) BC very much invested in their online presence for the PCR kit - testing the market with one product first (though some may disagree)
3) Delays to POC - which could be linked to BCs involvement now.
4) And just the pure lack of updates - seems to me as there could be other people pulling the strings.
All that said, £1 buyout (approx £63mil) is way too low for the product line of GDR.