Member Info for Bella6532

Was this the one:
'We're pleased to announce we've been selected for @NIH RADx program for the accelerated development of our #COVID19 rapid antigen self-test. Through the US initiative, our test will be supported in development and manufacturing, incl. regulatory guidance:'

Right now he's not profiting from the purchase of said shares should he have received a heads up that we have our CE. If the news breaks tomorrow and we get say a 50% spike and he sells his shares, then I guess you could say it would be classed as insider trading then. If he holds onto his shares for a year or so then no problems.
Fine lines...
All Directors have the inside track and many buy knowing something we mere mortals don't....but they do often buy in at least some days or maybe a week or so before they break the news...

They announced their Interims on 9 March so he's well outside the Closed Period which is a period leading up to Results being issued and a time when Directors are prevented from buying/selling their own company shares.

NOW WHO MEETS ALL THE CRITERIA...

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medically trained professional or have experience working in a laboratory setting
tests administered by a healthcare or medical professional
Other characteristics for lateral flow devices
DHSC has identified other desirable characteristics for lateral flow devices that are in addition to the selection criteria that are outlined above.

The desirable characteristics will not inform the prioritisation for validation, but are included to provide suppliers of lateral flow devices with a better understanding of DHSC's likely requirements for predicted future use cases:

the ability to supply lateral flow tests in various pack sizes - for example, pack sizes of 1, 3, 5, 7 and 25 tests
proof that the test was run with actual human sample - for example, the inclusion of a control line specific to human mucosal antigens
each sterile swab has an individual containment tube with recappable lid, providing the ability to store the swab for quality review
the ability to provide a response in 15 minutes or less
an individual QR code on the test cassette - this is essential.

Overview
The Department of Health and Social Care (DHSC) has concluded a review of the most likely future requirements and use cases for rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices).

The review has enabled the development of selection criteria. The selection criteria will be applied to decide which lateral flow devices should proceed through the validation process and the basis on which the validation of certain types of lateral flow devices should be prioritised.

The rationale for this approach is that DHSC will only seek to validate lateral flow devices that have predicted future use cases and that the resources available for validation will be best deployed to align with the national strategy for Test and Trace.

This page sets out the selection criteria for lateral flow devices. The validation will continue to follow the government protocol.

Sample type
DHSC will no longer validate lateral flow devices that only allow for a nasopharyngeal or oropharyngeal specimen collection method or both. Instead, the instructions for use (IFU) for the lateral flow device must contain a specimen collection method that allows for one or more of the following sample types:

anterior nares
mid-turbinate
saliva
This list is written in priority order: lateral flow devices submitted with a specimen collection method higher up on the list will be prioritised for validation. A lateral flow device will only be considered for validation when all lateral flow devices with a higher priority specimen collection method have been considered for validation.

Other sample types, which are not included in the list above, will be evaluated on a case by case basis.

Symptomatic and asymptomatic testing
Priority will be given to lateral flow devices where the IFU or other packaging labels do not restrict the use to symptomatic individuals only or other wording to this effect (for example, ‘patients suspected of having COVID-19’). Lateral flow devices will ideally allow for both asymptomatic testing and symptomatic testing.

Users and administrators of lateral flow devices
Priority will be given in the following order for lateral flow devices where the IFU and CE mark allow for:

self-test: a test that can be performed by any individual at home without receiving prior training – you can find out more about CE marks, UKCA marks and MHRA exemptions from medical device regulations that allow lateral flow devices to be used in self-testing
self-swab and the test is then performed by a trained individual: the IFU allows for a patient to collect their own sample, either supervised or unsupervised - the test procedure can then be performed by an individual who has received training
test performed by a trained individual: the test can be performed by someone who has received training - this person does not have to be a medically trained professional or have experience working in a laboratory setting

(Approx 55m adults in UK x 2 tests per week = 110m plus hospitals, care homes, test and trace, doctors, work places, schools etc etc...
UK production alone won't be enough...not yet anyway...
The Govt has to secure volume and chip to support locally produced...
Not going to be much, if any spare capacity to sell to other countries either...
So by the looks of it there's going to be room for several UK produced LFTs...
Now the point is..how many will actually contain our affimer...how many will or are looking to switch to an affimer to get much higher accuracy to catch the low viral loads/asymptomatic cases.
As soon as approval is given for our affimer based LFT there MUST be a clear definition made so we don't continue to be lumped in with the cheap and cheerful test which miss so many cases...

Great summary PSB123.
Have to say this mornings RNS was a surprise but very, very welcome. It now takes the pressure off Avacta at the Elisa end. It's a Global Distribution deal and I'm sure this has been put together on the back of high interest being shown out there, not just catalogue filling.

This para is very interesting and includes two key pieces of info:
'ABCAM is one of the world's leading suppliers of high-quality biological reagents and kits which are used in a wide range of fields including drug discovery, diagnostics and basic research. Under the worldwide, non-exclusive distribution agreement, ABCAM will enable the global research community to access Avacta's SARS-CoV-2 spike protein Affimer® research reagents through its on-line catalogue. This will allow scientists around the world to perform the ELISA test in their own laboratories and support the global fight against the pandemic.'

1. 'Under the worldwide, non-exclusive distribution agreement,...'
2. 'ABCAM is one of the world's leading suppliers..'

So this means the door is wide open for Avacta to discuss/to be discussing further agreements with those other leading suppliers and shows they are not prepared to just give away exclusivity regardless how big a company might be or their global reach...Nice one Avacta...

'The cryptocurrency space can reach its full potential only after bitcoin mining starts using 100% renewable energy, said Ripple’s CEO, Brad Garlinghouse.'

As Avacta is a listed company and now the Govt has announced their new free testing programme perhaps they will allow companies like ours in the consortium to give their shareholders an update/bit more info. Maybe not full disclosure but more than we've had to date.

ITS OLD NEWS ANYWAY...

'Monday, 8th February 2021, will surely go down as one of the proudest days in SureScreen Diagnostics’ history.

Prime Minister Boris Johnson visited our manufacturing site as the UK Government officially announced that we had secured an order for 20 million rapid COVID-19 antigen tests.'

Thanks Fastcar19...that's why I said I didn't think we would be included in this mass test roll out initially...unless of course we have been obtained both professional and nkn-professional at the same time and we get the announcement tomorrow...

Thanks hants...so either the Govt chooses to ignore the professional use only or due to non disclosure Avacta could only mention professional use instead of professional and non-professional or they just had to keep it as vague as possible...
Surely our test is easier to administer so why the professional reference...so odd...or are they referring to the EU CE mark not the new UK CEMark...
Professional use in EU but can be non-professionsl in UK...
Our RNSs have obviously been worded to avoid any slips when it comes to the non disclosure but at the same time keeping to regulatory news disclosure rules...fine lines and reading between the lines needed...

GMCC...Perhaps we aren't going to be part of the General public roll out as Avacta do keep referring to 'for professional use'...why...does this mean fir doctors offices and within hospitals and nursing homes etc where accuracy is far more critical???. Maybe the govt doesn't want to spend much on free mass tests but happy to pay more where accuracy really is key..ie in the places where you have vulnerable people...
'On the basis of these excellent initial data, the Company will now progress to a full clinical validation with a larger number of patient samples to CE mark the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year."'

TPNY...and I hope the push the new highly accurate element too since LFTs have undergone a knocking for their false negs etc...

'The partnership will provide a faster route to market for Avacta's rapid antigen test by CE marking it for professional use under Mologic's existing ISO13485 quality system. The CE mark will then be transferred to Avacta when it receives ISO13485 accreditation, which is expected by the end of March 2021.'

Let's hope we get RNS re accreditation tomorrow which will then open many other doors to low and middle income countries too...

Agree this is based on the Govts consortium bringing together several raw material suppliers/manufacturers.
Offering two tests per week to every adult (18+) in the UK is a huge amount and you have to add this to schools testing etc. Packs of 7 will be available from chemists so the amount manufactured will be enormous.
Avacta will be one of the companies for sure...it could be, and I hope not, that companies like Surescreen might be in the first batched of roll out with other being added as the scheme rolls out and demand increases.
We have to be careful we don't get too overly upset if we don't get that RNS tomorrow..it will come...

'At-home self Covid tests will be on sale in France from April 12
The tests will be available from Monday April 12, and will only be available to buy in pharmacies, Health Minister Olivier Véran has confirmed. Pharmacists will give buyers instructions and useful tips on how to use the tests.

The tests are done by nasal swab, but are less invasive and unpleasant than the deep nasal swabs needed for RT-PCR tests. Any positive at-home tests will need to be confirmed by a proper RT-PCR test, health authority la Haute autorité de Santé (HAS) has said.'

The EU is hoping to launch one by June for the whole block...the UK will have to launch one so people can use it to travel. I don't see what the fuss is about...they won't complain if they have to download to go on holiday but already complaining to go to watch their favourite football team...yet happy to give all sorts of info to get a store card, shop online etc...
https://www-thelocal-it.cdn.ampproject.org/v/s/www.thelocal.it/20210328/eu-vaccine-chief-hopes-for-tourism-boost-as-he-unveils-covid-19-passport/?amp_js_v=a6&_gsa=1&&usqp=mq331AQHKAFQArABIA%3D%3D#aoh=16174459873908&referrer=https%3A%2F%2Fwww.google.com&_tf=From%20%251%24s&share=https%3A%2F%2Fwww.thelocal.it%2F20210328%2Feu-vaccine-chief-hopes-for-tourism-boost-as-he-unveils-covid-19-passport%2F

So Boris will be giving an update on Monday...could this lead to news on Tuesday morning if he mentions new Govt tests going to be made available...
Our broker will know if news is imminent...any deramping now is pointless if Tuesday morning is the day...