The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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Told you all this last week and got ****ged off for it.
LFT is a sideshow.
Oncology is the main play.
“Under Secretary of State for Vaccines and Public Heath” Says it all really. Vaccines now = public health. You can see your GP to get a jab and that’s about it.
Why anyone still expects this Gov to behave rationally in response to this pandemic is beyond me. They have done their level best to sideline LFTs. As I have said previously, they will only want to use them when it suits their agenda.
Anyway, I’m off to prep for the winter. When they tell you that there are no supply issues, you know they are coming (especially because the WEF has already wargamed it with project Cyber Polygon)
GLA.
SureScreen? The same Surescreen with the street trader's web site with dead links and the home made video? God give me strength.
Page 2
'We applied to the Medicines and Healthcare products Regulatory Agency (MHRA) for an ‘exceptional use’ authorisation for the Innova LFD, and Orient Gene independently applied. The MHRA provided the authorisations to fill short-term gaps in the market, as no CE-marked self-tests were available. Both devices have subsequently been deployed in the UK, with the authorisations providing the regulatory authority for deployment.
The process of applying for an exceptional use authorisation requires the applicant to provide data to support the intended use of the LFD test. In these instances, we, on behalf of Innova, and Orient Gene provided the MHRA with data in support of applications for LFD tests that use a lower nasal swab and are intended for use on asymptomatic individuals. Furthermore, we conducted field service evaluations before deciding to deploy the LFD tests. The results of these evaluations can be found at www.gov.uk/government/publications/lateral-flow-device-performance-data.
It is important to note that the approval for the exceptional use authorisations is time-limited and is granted on the condition that a CE mark for self-testing, the standard regulatory approval process, will be obtained by Innova and Orient Gene.
The UK was ahead of the world in embracing LFDs, and they continue to be a central part of the Government’s strategy to combat COVID-19. These innovative technologies will allow infectious individuals to be identified, isolate and prevent onward transmission, reducing illness and the burden on the NHS and saving lives.
I hope this reply is helpful.
MAGGIE THROUP'
Maggie Throup MP
Parliamentary Under Secretary of State for Vaccines and Public Health
The following letter was sent to me via OP my MP
'15 October 2021
Dear Owen,
Thank you for your correspondence of 25 June on behalf of your constituent, Ms XXXXXXXXXXX, about the manufacturing and validation of COVID-19 testing kits. I apologise for the delay in replying.
I am grateful to you for raising Ms XXXXXXX’s concerns.
Alongside the symptomatic testing service, NHS Test and Trace is using rapid-testing technologies for asymptomatic individuals and to improve our detection of positive cases. Roughly one in three people who have the virus do not have symptoms and could therefore be spreading the disease without knowing it.
We are committed to boosting UK manufacturing and demonstrated this with the award of a contract for 20 million devices to Derby-based test manufacturer, SureScreen Diagnostics. These lateral flow device (LFD) tests were the first British tests to be validated in the laboratory by Public Health England.
Collaboration between industry and Government continues to be a priority and we are hugely grateful to all the manufacturers and suppliers that have come forward to offer their assistance in producing LFD tests.
The valuable partnerships being created with companies such as SureScreen Diagnostics are further contributing to the resilience of the UK, both through supporting the work of UK diagnostics manufacturers and by harnessing the possibilities opened up by rapid regular testing.
Our Dynamic Purchasing System, a procurement tool that allows qualifying suppliers to compete for contracts, will diversify the supply of LFD tests through fair and transparent competition. Further information can be found at www.gov.uk by searching for ‘national technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests’.
To be purchased by the department, LFD tests need to have been validated by Porton Down and must have regulatory approval in the form of either an exceptional use authorisation (EUA) or a European conformity (CE) mark. None of the products for self-testing with Medicines and Healthcare products Regulatory Agency EUA approval or a CE mark is currently manufactured in the UK.
The process of deploying an LFD test, such as those supplied by Innova and Orient Gene, into the mass-testing programme is robust, consisting of detailed validation and evaluation of the LFD prior to deployment. LFD tests have been rigorously tested and are safe for regular use; any suggestion otherwise is inaccurate and potentially harmful.
All LFD tests that we procure undergo an extensive clinical evaluation by Oxford University and Porton Down. This is to confirm that the tests display performance characteristics desirable for mass-population and community-based testing. The desirable performance characteristics are high specificity and sensitivity against the viral loads associated with infectiousness, and the work performed at Porton Down assesses the clinical performance of LFD tests. '
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