Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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
Hopefully GDR are on board with this!
https://swachhindia.ndtv.com/delhi-government-issues-new-guidelines-for-covid-19-testing-45565/
The world needs reliable GDR testing now!
India's coronavirus infections surpassed 200,000 after cases jumped by 8,909 on Tuesday in one of the highest single-day spikes.
Brazil reported 1,262 deaths from COVID-19 in the 24 hours to Tuesday night, another daily record.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-1-2020I don't know if this has already been posted but the FDA are obviously very busy, so patience is key!
Testing updates: 01/06/2020
During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
To date, the FDA has authorized 117 tests under EUAs, which include 101 molecular tests, 15 antibody tests, and 1 antigen test.
I don't want to be a party pooper but have just been reading this article!
https://gulfnews.com/uae/covid-19-test-results-in-seconds-using-laser-instead-of-dna-in-abu-dhabi-1.1589962840167
Sounds too good to be true. Often the case!
https://www.basingstokegazette.co.uk/news/regional/andover/18354750.basingstokes-super-fast-covid-test-set-rolled-across-uk/
C'mon GDR - Give us the CE approved gold standard test for the world!
I started following GDR when the shares were around 30p but didn’t invest at that point as I have been stung on quite a few occasions with Aim shares. I have found all the positive posts and info really interesting and am convinced this share will do well. After my own research I dived in at 77p and haven’t looked back since. I can only assume that for the phase 2 rollout that would be a massive benefit to the care homes sector to keep staff and residents Covid free. Looking forward to next week. Exciting times ahead!