Member Info for Timster

Are we able to state or at least firmly speculate which two tests avacta was trialled against ?

One of them had to be Innova surely. Then it's anyone's guess what the other was there are loads of commercially available tests. It may have even been surescreen or Mologic

Is he aware of which tests Affidx went up against when they confirmed 100% detection rate of the delta variant and the other two 0% and 50%

But let's be honest he's not going to give you anything other than the party line.

when you say open a dialogue, do you mean just send him an email which will probably be ignored?
or an actual conversation?

can he explain why porton down and MHRA thinking is so different from the FDA
https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-medical-group-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication

We've seen massive after hour sells and massive after hours buys.
Always made a big thing of, next day trading makes feck all difference...

I responded on several points but also asking why the MHRA could be so far away from the FDA's assessment of Innova.

an bighero is in, he's very rich don't you know!

Don't think it will move it as it's expected and known to be end of July

Twats

Feel for the people who sold when the goons were (allegedly) attacking the board on Monday

It would appear so pigster. So they can continue to use up the trash even though they are fully aware it's trash

with which their manufacturer has contracted with. This is to avoid potential issues emerging particularly this autumn due to the length of NHS contracts. This means where a pre-existing contract exists, it can continue to be honoured by the manufacturer even if the test has failed validation before all deliveries are completed under the contract. Going forward the improvement to the quality of all tests on the market as they meet the new standard will provide all consumers including public bodies with a better range of tests to choose from in their procurement and avoid the cost of their own assurance processes (see paras 7.7 and 7.8 of the EM).

The Department of Health and Social Care has published guidance on Covid-19 test performance – Technologies Validation Group: using tests to detect COVID-19 (17 June 2021) – but it is not clear from the document if/how it relates to the Government’s draft Regulations on validating private Covid-19 tests.


I hope that information is helpful and thank you for contacting me regarding this important matter.

we have taken the decision not to make the laboratory element of validation a mandatory requirement. Initially, we have decided to implement mandatory validation of COVID-19 tests via a desktop review delivered by DHSC. The government intends to introduce mandatory laboratory technical validation at a later date.

Further details are also given about the “desktop review”:

We are proposing an approval regime that would require persons seeking to bring a test to market in the UK to register via an online portal. CE marking will be a prerequisite for applying for validation. They would then submit data for a thorough desk-based assessment including evidence of laboratory validation already conducted. A register of all tests that pass the validation process would be published on GOV.UK, providing consumers with clear comparable data, making it easier to assess the performance of different tests on the market and make informed decisions when purchasing a test (DHSC, Private coronavirus (COVID-19) testing validation: government response, 17 June 2021).

The draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 were laid before Parliament on 17 June 2021. The draft explanatory memorandum accompanying the Regulations explains that, through the SI, the Government intends to establish:

a requirement that all COVID-19 tests placed on the UK market undergo a mandatory approval process, to validate them as meeting high quality standards. Following a transition
period, tests that fail this process would be barred from sale. Retailers, distributors and manufacturers of tests that attempt to sell unapproved tests would face sanction.

The draft Regulations, which would apply to the entire UK, are to be made under section 15 of the Medicines and Medical Devices Act 2021, following the draft affirmative procedure (meaning both Houses of Parliament have to approve the Regulations before they are signed into law). While the motion to approve the SI has been tabled by the Government in both the Commons and Lords, I cannot see that a date has been set by either House for the formal consideration of the SI.

Tests supplied by government will be exempt from validation. The draft explanatory memorandum states the following on this point:

To avoid duplication of work tests supplied by government will be exempt from validation. This is because the market validation is based on the validation DHSC [the Department of Health and Social Care] has been doing for public procurement of tests as such these two validation process are judged to be equal. As such DHSC will place tests onto to the market without undergoing the regulatory validation process conducted by DHSC to control access to the UK market.

Further to avoid potential supply issues in NHS hospitals where a contract exists for the supply of tests, those tests will be grandfathered and exempt solely for the life of that contract to the specific NHS hospital

Got mine too, from Chris ellmore labour
Following your contact, I have spoken with the House of Common’s Library specialist on medical testing. They have since provided the following information which I have shared below – that I hope is helpful and of interest:


Accuracy of lateral flow tests
The Parliamentary Office of Science and Technology has produced a briefing on the topic – Mass testing for COVID-19: January update on lateral flow tests (29 January 2021) – which you may find helpful.

Regulation of NHS Test and Trace LFDs
The Medicines and Healthcare products Regulatory Agency (MHRA, which is responsible for regulating all medicines and medical devices in the UK) recently extended “the Exceptional Use Authorisation (EUA) for NHS Test and Trace lateral flow devices (LFDs) used as part of the Government’s asymptomatic testing programme to 28 August 2021” (see MHRA, Following a satisfactory review, MHRA extends authorisation of NHS Test and Trace lateral flow devices, 17 June 2021).

The MHRA explains that it can issue EUAs under “exceptional circumstances” to allow “medical devices to be used that have not followed the standard approval process”. It added that the extension followed a “satisfactory outcome of [its] review undertaken as a result of recent action in USA. The US Food and Drug Administration (FDA) recently issued a warning about LFDs manufactured by Innova Medical Group Inc in the United States” (for further information about the FDA’s position, see FDA, Stop Using Innova Medical Group SARS-CoV-2 Antigen Rapid Qualitative Test: FDA Safety Communication, 10 June 2021).

Validating private Covid-19 tests
A Department of Health and Social Care consultation on Private COVID-19 testing validation ran from 8 April to 5 May 2021. In its consultation document, the “problem the government is aiming to solve” was set out as follows:

Consumers need to know that COVID-19 tests they buy are of satisfactory quality. This requires tests with sensitivity that is high enough to apply in ‘real world’ settings that provide accurate results and avoid spreading the virus.

Excluding self-test kits, there is currently no legal requirement available for independent validation of COVID-19 tests performance. Entry to the market is controlled by CE marking which is currently a self-declaration process for the performance of this type of test kit or equipment. This means performance is not independently verified ahead of sale (see DHSC, Private COVID-19 testing validation, updated 17 June 2021).

The Government Response to the consultation was published on 17 June 2021. It concluded:

we have decided to take steps to lay a Statutory Instrument under the Medicines and Medical Devices Act 2021 (MMDA) to create a regulatory requirement for the mandatory approval of antigen and molecular diagnostic tests for COVID-19. However, at this stage, we have taken the decision not to make the laboratory element of validation a mandato

Timbo did already see below

And no need to thanks me for passing on that today would be an RNS day.
No problem at all...

Lol, the sujood bot is back. Dates in your precious dairy 2019 - 2021

First bump, Ba-la-la-la-la

Definitely global the master hind sight imaginary trader

Glad mortgage is there to past every RNS as soon as released, really is a strange one, bashes the CEO all day (but not on twitter)

I like thought 2, that makes sense