Member Info for flyingmachine

The UK PCR test market is not a closed shop. DHSC is continually running a diagnostics efficiency improvement campaign (headed by Lord Bethell). Within that I know that Doris Ann-Williams, a key figure in that campaign, is leading the efficiency and speed of testing challenge group and she is already exchanging information with DB about the USPs of the GDR PCR test. Now that GDR PCR tests has the CE Mark DB is able to provide all the validation information requested from that group (yes, they have asked for it!). So watch this space....

UsersSteve, you certainly are no good at your research since the question you ask to confirm the two genes that the GDR test looks for is stated on the Genedrive website. I can't even be bothered to send you the link because I know your motivations are totally different to mine. Perhaps if youdo bother to look you will come across the USPs of the Genedrive PCR test, that will tell you why the Gendrive PCR test will sell well. But I don't think you will bother, will you....

Invalid comparison, then and now......NCYT had first to market advantage, in early stages of Covid-19 everything was rushed. Govs are wiser now to the fact there are good tests and not so good tests, they do proper evaluations now which only makes a few weeks difference in making sales. It is widely known now that NCYT did not get French Gov approval for test reimbursement because NCYT test only looks at a single gene, so nowhere near best in class.

The cream will rise to the top and GDR has USPs that were clearly shown in DBs presentation yesterday. In his final comments yesterday he expressed....""faith and confidence of significant orders and commercial contracts".

RT-PCR molecular testing and POC testing are going to complement each other in the Covid testing landscape. RT-PCR will still be the clinical 'gold standard' test in the future where this is available in the professional clinical setting (hospitals, labs etc). There is certainly still a gap for POC testing yet to be filled. In that space there will be two variants - mobile PCR and antigen tests. Each will have there place according to the use case and accuracy required for the test and the clinical setting. The difference between POC antigen and mobile PCR testing are where they might be deployed (use cases) which will be dependent on the final accuracy that POC antigen testing can achieve. In professional environment use cases (football or other professional sporting clubs, clinics, large companies etc) I expect mobile PCR testing to hold its own due to superior accuracy and importance of this higher accuracy and reliability in these environments. POC antigen testing will find its place in mass screening but to what extent will all come down to the final antigen testing accuracy, they are not as accurate as PCR molecular tests by their very nature. MHRA has not yet published the TPPs for POC antigen tests.

Ophidian, that's a very good sensible and realistic timeline. Give or take just a week or two, here and there, it aligns with my own expectations.

Part 2/2:

AIHL MT-RNR1 ID Kit Summary:

MT-RNR1 ID kit runs on Genedrive platform and can save total hearing loss of babies admitted to Neonatal Intensive Care that suffer from genetic mutation called MT-RNR1 and who are vulnerable when given the antbioticgentamycin.

- First to market with such a test, first company in the world to develop a gentic test for rapid testing of this sort.
- Result in 27 mins. Babies can be given alternative antibiotic if they have the MT-RNR1 gene mutation.
- Profound benefit to the baby for the rest of their life.
- Approximately 90,000 babies admitted to NICU in the UK
- Assume 'Western World' market opportunity 1.25m test/year
- Test economics - <£10 to make, £35 to distributors, £50-£85 direct depending on reimbursement/country
- Approx. 1 in 500 carry the mutation
- Based on this muttaion frequency approximately 2500-3000 babies could be prevented from going deaf every year in EU/USA
- Global market value estimated at £40m-£65m per year depending on route to market.
- USA market a great opportunity - consider the litigation culture over there and the situation where parent's baby has been made deaf by incorrect antibiotic being given, when not running a gene mutation test which is readily available!

USA DOD contracts :

500 Genedrives already sold/contracted to DOD. To be followed by multi-million contracts for tests - my notes on this were a bit slim but the upshot is that this should also be a valuable and on-going income stream for Gendrive.

Genedrive POC for Covid-19: Expect delivery towards end of this year.

Part 1/2
Here are the main summary points I gathered from DB's presentation yesterday. I'll start off with a final comments made by DB, he expressed......"faith and confidence of significant orders and commercial contracts"....

Gendrive 96 SARS-CoV-2 Summary:
- Huge market potential, vast majority of countries still in Covid infection escalation
- Much simpler than other PCR tests : 4 steps (vs 5 or 6), 1 pipetting step (vs 2 or 3),
- Unique product design with meaningful, valuable benefits to the user : unique Human RNA check (swab collection validity)
- Top tier clinical performance specifications - 100% sensitivity, 98.2% specificity.
- Temperature stable nature facilitates global distribution to global markets
- Competitive pricing (£8-£10 per test) with attractive margins (60%)
- Commercial scale manufacturing capability with Cytiva - 10,000 beads per hour
- Distribution routes established and even more being established : listed dozens of countries in Europe, Africa, Middle East as well as India and USA (see list below)
- CE Marking achieved, additional registraions in process (eg WHO, FDA and India)
- Global pandemic continues to grow, making global distribution capability important
- Covid-19 can only be controlled through constant monitoring (testing), social distancing, and treatment (vaccine)
- Genedrive anticipates recording first sales in June
- Current distribution agreements -
Europe (CE Mark approved): Austria, Germany, UK, Switzerladn, Turkey, Spain, Portugal, Belgium, Netherlands, luxembourg, Poland, Hungar, Czech Republic, Solovakia, Sweden, Norway, Denmark, France, Cyprus.
Central Europe (CE Mark Approved): Romania, Slovenia, Croatia, Ukraine, Estonia, Lithuania, Latvia, Moldova, Albania, Bulgaria, Serbia, Bosnia and Hercegovina, Montenegro.
Africa (WHO EUA applied): Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Congo, Democratic Republic of Congo, Cote d'Ivoire, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Morocco, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Seychelles, Sierra Leone, South Africa, South Sudan, Sudan, Swaziland, Togo, Tunisia, Uganda, Zambia, Zimbabwe.
Middle East: Iran, Iraq, Saudi Arabia, Yemen, Syria, UAE, Israel, Jordan, Palestine, Lebanon, Oman, Kuwait, Qatar, Armenia, Bahrain, Turkey, Azerbaijan, Uzbekistan, Tajikistan, Turkmenistan, Kyrgyzstan, Kosovo, Kazakhstan.
Desired Distribution Channels: USA (in progress, FDA approval applied), South America, Mexico.

For anyone that likes to know a little bit more about Covid diagnosis, how it works, the different types etc then this easy to read chart tells it all in a nutshell. It also has a list of FDA EUA approved Covid tests. I look forward to seeing v1.36 with Genedrive 96 SARS-CoV-2 listed on it very soon!

https://csb.mgh.harvard.edu/covid

Thanks sjpw. I appreciate that.

...and regarding my second (advantage) point for Avacta in the current delay with the TPP. As stated that the Gov knew about Avacta - this can even mean there is some collaboration with the Gov around the TPP requirements for antigen POC tests. No good MHRA setting such a high bar that cannot be met by any antigen POC test, ss perhaps that bar might be set by what Avact can achieve with the affimer driven LFT test.

sjpw, I have never praised Sona.

I didn't start this Sona thread.....I thought the question was 'how is our closest antigen test competitor doing?', so I was contributing what I knew.

There are actually advantages to Actava for the current delay in their LFT prototype. Firstly, if Sona do come out first with a validated test then Avacta know what they need to beat or at least 'equal'. Secondly, the MHRA has not yet published the TPP for antigen POC tests (not due till the end of June, though there was some talk of it being there today but it has not appeared). This is likely top be a higher bar than FDA EUA. So, it benefits Avacta to wait for the TPP to be published so that they can confirm the requirement that the MHRA sets.

So being first is not important.

Wiggly, not according to their Investor pack, slide 7, published on 25th May......"Process scalable to 10,000L per year current facility - will serve 100M lateral flow tests, further capacity can be added as necessary".

The Sona Nanotech Investor pack can be found here....

https://sonanano.com/wp-content/uploads/2020/05/Sona_Nanotech_investor_deck_May_2020.pdf

From David Budd's presentation :

MT-RNR1 ID kit runs on Genedrive platform and can save total hearing loss of babies admitted to Neonatal Intensive Care that suffer from genetic mutation called MT-RNR1 and who are vulnerable when given the antbioticgentamycin.

- First to market with such a test, first company in the world to develop a gentic test for rapid testing of this sort.
- Result in 27 mins. Babies can be given alternative antibiotic if they have the MT-RNR1 gene mutation.
- Profound benefit to the baby for the rest of their life.
- Approximately 90,000 babies admitted to NICU in the UK
- Assume 'Western World' market opportunity 1.25m test/year
- Test economics - <£10 to make, £35 to distributors, £50-£85 direct depending on reimbursement/country
- Approx. 1 in 500 carry the mutation
- Based on this muttaion frequency approximately 2500-3000 babies could be prevented from going deaf every year in EU/USA
- Global market value estimated at £40m-£65m per year depending on route to market.
- USA market a great opportunity - consider the litigation culture over there and the situation where parent's baby has been made deaf by incorrect antibiotic being given, when not running a gene mutation test which is readily available!

From the David Budd's presentation ....

- Huge market potential, vast majority of countries still in Covid infection escalation
- Much simpler than other PCR tests : 4 steps (vs 5 or 6), 1 pipetting step (vs 2 or 3),
- Unique product design with meaningful, valuable benefits to the user : unique Human RNA check (swab collection validity)
- Top tier clinical performance specifications - 100% sensitivity, 98.2% specificity.
- Temperature stable nature facilitates global distribution to global markets
- Competitive pricing (£8-£10 per test) with attractive margins (60%)
- Commercial scale manufacturing capability with Cytiva - 10,000 beads per hour
- Distribution routes established and even more being established : listed dozens of countries in Europe, Africa, Middle East as well as India and USA.
- CE Marking achieved, additional registraions in process (eg WHO, FDA and India)
- Global pandemic continues to grow, making global distribution capability important
- Covid-19 can only be controlled through constant monitoring (testing), social distancing, and treatment (vaccine)
- Genedrive anticipates recording first sales in June

the '*****' is v o x m a r k e t s with no spaces between letters.

Try this....

https://**********.brand.live/c/genedrive-plc

I am looking forward to DBs presentation this afternoon, not least to confirm the interest around potential India test distribution through Divoc Health. I am pretty certain he is aware of this, so should be able to talk about it on the 2pm call as it's in the public domain already. Everything we have found has pointed to Divoc Health being totally valid, even confirmation from Lions Head Global Partners but a final confirmation from DB will 'seal the deal' on this.

India, currently doing 100,000 tests per day with immediate plans to increase to 200,000 per day, but ultimately need to scale up by a factor of 10 (!!) to 1 - 2 million tests per day for their population size.....

"https://www.cgdev.org/publication/indias-covid-19-testing-capacity-must-grow-factor-10-heres-how-can-happen"

I think Genedrive and our two distributors can help with this!

I posted this on the 4th June, after the placing....

"Myles, the placing was a shock, but logical. I believe AS is a smart CEO andappreciates that there is still potential for the POC Covid test to fall flatter than people expect because since it is an antigen test, it will not be sensitive enough in clinical settings (a limitation of antigen testing) so would simply become a pre-screening test before a more accurate PCR test is taken. This is even the use case description in the investor literature (May 22nd) of their closest competitor, Sona Nantech, who are already in POC test validation. AS hedged his bets - raise the money from placing now to fully fund the precision cancer treatment trials to completion before the final results of the POC test development and validation come out, since it could be not as good as everyone has been lead to believe.