Member Info for Bobbyk

@jayhayes
I think you may be a little over optimistic on your figures!
You have to take into account there are already 53 authorised labs to do the testing. As of today the Indian population is shown as 1,379,567,062 and divided by 54 if Genedrive join the party they would only get circa 25 million tests giving an income of over £200 million at £8.00 a shot. But I suppose that would do for starters LOL

If we are to get a piece of the action in India we need that authorisation asap!
Covid-19: India enhances its testing capacity, ramps up to 3 lakh samples per day
Jun 17, 2020, 11:02AM ISTSource: TNN
India has stepped up testing capacity significantly for Covid-19 to three lakh samples per day with a network of 907 laboratories — 659 in the government sector and rest private labs — spread across the country. At present, India is testing around 1.5 lakh samples every day. In the last 24 hours till Tuesday morning, a total of 1,54,935 samples were tested. So far, the daily testing capacity was 2 lakh samples a day.

I do hope the development of the GDR POC test is making good headway. India is crying out for fast reliable antigen testing along with the rest of the world!
ICMR has asked other manufacturers and developers, who have antigen detection assays, to come forward for validation.
“Currently, there is just one manufacturer but we are hoping many will come forward so that this testing can be expanded in states,” said Sharma.
https://www.hindustantimes.com/india-news/icmr-advises-rapid-antigen-kits-for-speedier-diagnoses/story-PEcxZEDwxrQpQC2aLv8aBL.html

Why would one of GDR’s Assay Development Scientist II leave the company after 5 years at such an exciting time and go and work for Cytiva this month?
She states
“At Genedrive plc I've been responsible for the development, optimisation and validation of fast-cycling, multiplex PCR-based molecular assays for use on the company's point-of-care molecular diagnostics platform.”
https://uk.linkedin.com/in/agnieszka-kuzdzal-1a234966
Any significance!

I am beginning to think we are late to the party in securing/announcing sales. In relation to the attached article, Hibergene, which is a small company based in Ireland secured sales for their POC test with Russia last month pending CE approval, which they now have, and have since secured deals with other countries
https://www.irishtimes.com/business/health-pharma/rapid-covid-19-test-by-irish-group-hibergene-gets-eu-approval-1.4257587
I just hope that when we rock up with the finest caviar and champagne it will be like bees round a honeypot and all the beer and crisps get left on the table!
C’mon GDR. It’s party time.

I look forward to them topping this chart too!
https://www.icmr.gov.in/pdf/covid/kits/RT_PCR_Tests_Kits_Evaluation_Summ_12062020.pdf

Fair comment BB and I hope GDR can break into the market

No need for rudeness saint -tropez.
My only thought was if they are not generating cash from the tests then how do they afford the raw equipment/compounds/swabs)
I want GDR to do well so I'll wait and see what Friday brings

https://www.hindustantimes.com/india-news/after-sc-order-on-free-covid-19-tests-private-labs-explore-legal-options/story-grPxNiRK8iqIZT5Pc7y4BJ.html

Indian Testing capacity
https://www.icmr.gov.in/pdf/press_realease_files/ICMR_Press_Release_India_testing_story_20052020.pdf

Unless GDR have already applied for validation for their testing kit in India I would be surprised if it was accepted as it shows the last date for tenders was 25/05/2020.
https://www.icmr.gov.in/tender.html
To date 97 different testing companies have applied with 40 being found to be satisfactory. Back in April an order by the Indian Supreme Court made all testing available for free so wonder how GDR will break into the market. At that time there were 139 government laboratories and 65?private ones that were authorised.
Just a thought!

Before we have any sales we will need to feature on this list!https://www.icmr.gov.in/pdf/covid/kits/RT_PCR_Tests_Kits_Evaluation_Summ_05062020.pdf

The fact that we are already CE approved will hopefully stand us in good stead.
Real-Time PCR kits which are US-FDA and/or CE-approved can be used directly after due marketing approval from DCGI. The complete list of US-FDA and/or CE-approved SARS-CoV-2 real time PCR kits is available at (https://www.finddx.org/covid-19/pipeline/).

It's a tough market out there! India has already evaluated 86 Covid 19 RT PCR tests and found 38 to be satisfactory.
Lets hope GDR is added to the list very soon because of their superiority!
https://www.icmr.gov.in/pdf/covid/kits/RT_PCR_Tests_Kits_Evaluation_Summ_30052020.pdf

We just need to remind ourselves what the RNS said!
Following CE-IVD marking, the Company can commence commercial sales in the UK and across the EU immediately. The Company will now begin distribution to potential customers for initial clinical evaluations, and aims to record first commercial sales in June.

Brazil has struggled on many fronts – and importing testing kits at a time when they’re in demand across the world has been one of the biggest challenges. But there has also been bad planning by the government.
“In February or March there was a huge flood of Chinese tests arriving in Brazil,” says Dr Celso Granato, the clinical director of Fleury laboratories in São Paulo.
“We tested 11 different brands of rapid tests and nine of the 11 were complete garbage.”
But, says Dr Granato, the government bought them anyway.
“They thought it was better to test with these kits than nothing but that’s not true – worse than not testing is testing with a bad test, you have bad results.”
Beyond political decision-making, the sheer size of Brazil is also a challenge.
Most of the laboratories capable of processing the RT-PCR molecular tests are in the south of the country. Safely transporting the tests from isolated areas such as the Amazon, which is one of the worst-affected areas, isn’t always successful – many tests have been ruined.
“Amazonia to São Paulo is about 3,000 miles (4,828km) and you have to keep the temperature constant from the moment you collect samples until the moment you receive the samples in the laboratory,” says Dr Granato.

Translation!
It was published in the Official Gazette (D.O.U), last Wednesday (18/3), the Collegiate Board Resolution (RDC) 348/2020 with extraordinary standards to evaluate applications for registration of medicines and products for the prevention and treatment of coronavirus (Covid-19). The rules will have a period of six months.
Extraordinary procedures for post-registration alteration were also published (company that promotes change in the original registration of the drug or biological product). There is also extraordinary change to the registration of products for the performance of laboratory diagnosis of the virus.
The purpose is to increase the range of prevention and treatment alternatives, in addition to avoiding product shortages. However, the goal is not to evaluate and approve products automatically, but to give more dexterity to the order analysis process.
In RDC 348/2020 (which can be accessed by this address: http://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-348-de-17-de-marco-de-2020-248564332), the registration of drugs and biological products will only be granted if the specific therapeutic indication for prevention or treatment of the disease caused by Covid-19 or in vitro diagnosis for SARS-CoV-2 is configured. (With information from Ascom/Anvisa - 19.3.20)

When you look at the experience of Tom Lindsay on the Genedrive Board, you would assume that he has contacts in India and Africa, both of which were mentioned recently in DB interviews.
Tom has 35 years of global sales and marketing experience in the diagnostics sector. He most recently worked for Alere Inc. in Africa for 11 years before retiring in 2017. At Alere he held a range of executive posts including President of Africa, President Commercial Operations for Africa, and Business Development Director for Africa; and led the introduction and successful commercialisation of a number of key HIV screening and HIV patient management point of care diagnostics technologies.
Prior to joining Alere Inc., Tom held senior commercial roles at Trinity Biotech (Ireland) including Marketing and Sales Director (Global) and Business Development Director for Africa, Middle East and India. Trinity Biotech specialises in the development, manufacture and marketing of diagnostic test kits.
Incidentally, I recently looked at Trinity Biotech and they were developing a POC system for Covid but I can't seem to find any reference to it now. Perhaps GDR's is far more advanced and will be ready to bring to market sooner!

Two years after that RNS, GDR weren't flavour of the month in relation to TB testing and if the recommendations shown in the attached letter were taken up then I can only assume we have WHO approval for the COVID test so would like to see an RNS showing that.
http://www.tbonline.info/media/uploads/documents/dcgi_genedrive_letter_draft_final.pdf

An article highlighting the need for testing in Africa. Oh how they need GDR!
https://www.msn.com/en-gb/news/world/coronavirus-could-smoulder-in-africa-for-several-years-who-warns/ar-BB159gHE?ocid=spartan-dhp-feeds