Member Info for oftinhope

Excellent. DBay still have 29%, bought at 150p, and a seat on the board. Presumably the sp will be held at that until they exit that position. Look forward to an rns confirming a reduction in the holding.

https://www.londonstockexchange.com/news-article/AZN/saphnelo-approved-in-the-us-for-sle/15081233
They get the first new treatment for 10 years accolade.

TechFT review
"As Facebook talks about immersive experiences, Samsung is providing one, with this 49in curved gaming monitor available for pre-order from today. The Odyssey Neo G9 features the first Quantum Mini LED display, with the LEDs a fortieth of the height of conventional ones and the tech making dark areas darker and bright areas brighter — a peak brightness of 2,000 nits and a static contrast ratio of 1,000,000:1 are cited. The screen has a 32:9 aspect ratio that offers Dual Quad High-Definition 5,120×1,440 resolution, a rapid 240Hz refresh rate and 1ms response time. The G9’s coolness factor is increased by a customisable lighting system for it, although Engadget swoons at the $2,500 price tag."

For more info :-
https://www.samsung.com/us/computing/monitors/gaming/49--odyssey-g95na-gaming-dqhd-led-monitor-ls49ag952nnxza/

Is this document
https://www.gov.uk/guidance/covid-19-test-approval-how-to-apply?utm_medium=email&utm_campaign=govuk-notifications&utm_source=08b8bf3b-5a84-4d08-affc-0bdb795d3871&utm_content=daily#outcome-reporting
and the linked documents relevant to Avacta's LFT? Seems more like a lab test from text below...
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005924/Test_performance_guidance.odt

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1005922/TVG_test_threshold_guidance.odt

Test Performance Guidance
This TPP is for laboratory based SARS-CoV-2 Viral detection tests.
Intended use
Desired
Multiplex - Determining current infection by detecting SARS-CoV-2 virus in samples from people of all ages at any point during active infection and differentiating from other respiratory infections
Acceptable
Determining current SARS-CoV-2 infection by detection of SARS-CoV-2 virus in samples from people of all ages during the active phase of infection.
Target user
Desired
Trained healthcare / public health professionals (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority ) and suitably trained and assessed as competent lab technician or scientist.
Acceptable
Trained healthcare / public health professionals (i.e. one of the 10 health and social care professional bodies that are overseen by the professional standards authority ) and suitably trained and assessed as competent lab technician or scientist.
Comment
A target user will perform the assay, interpret and communicate the results.
Full training appropriate to the intended user is required.
Target use Setting
Desired
Healthcare and Medical Laboratories
Acceptable
Healthcare and Medical Laboratories
Comment
These exclude Point of Care (POC) testing environments which will utilise test types that are appropriate for that setting.
Turnaround time
Desired
Less than 90 minutes from sample to result.
Acceptable
Less than five hours from sample to result
Comment
The time is from receipt of sample in test laboratory.
Throughput
Desired
More than 200 tests in unit per 4 hours
Acceptable
More than 50 tests per unit in 4 hours
Hands-on time
Desired
Less than five minutes per sample
Acceptable
Less than 20 minutes per sample

I was pleased to see a response to my Q22 which was looking to see whether there was an application for an AVA6000 derivative to destroy CTCs before they metastasize and become new tumours. An engineering approach rather than an oncological approach. It seems not, but there maybe scope for another CTC-specific affimer to be developed which can latch on to and damage that CTC. Of course, it is easy to capture CTCs with another techonology from ANGLE (AGL), in which I have an interest, so evolving an appropriate affimer should be relatively straightforward.!

The Avacta RNS says one thing, the BSI scope says similar. Avacta manufacture and supply Affimer reagents.
The RNS statement ”ISO 13485 certification means that the CE mark for the AffiDX® SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner, Mologic, and Avacta will be legal manufacturer of all future in-vitro diagnostic products.” is troubling. If Avacta was able to demonstrate evidence of its capability to design, develop and manufacture an LFT then the scope should include these activities.
My understanding of ISO 9001 and 13485 etc does not extend Avacta's capability to the design, development and manufacture of LFT's. Perhaps there is an overriding government EUA for UK demand but I struggle to see how a market in the EU or elsewhere can be fulfilled with LFT product supplied by Avacta given the information I have to hand. It will be interesting to see how Calibre react.
Acquisition of an LFT developer/manufacturer with ISO 13485 would be a solution to this issue. Licensing an LFT developer/manufacturer is another. Either way, capital costs/lower income have not been factored in by the posters on this board in recent months.

Avacta have not sought the ISO 13485 scope for design and manufacture of devices. For example, Mologic's scope is
"Design, development and manufacture of professional and self-test immunodiagnostic (lateral flow) IVD devices for the detection of infectious disease, inflammatory biomarkers and human Chorionic Gonadotropin (hCG). "

Avacta's scope is "The manufacture and distribution of Affimer reagents for use by third parties for Lateral Flow, ELISA and immunodiagnostic in-vitro diagnostic devices." It is limited to reagents. It is possible that control of design and development falls under some other regulatory controls that have not been described on the website or in previous communications. But even if Avacta subcontracted the design and development of the LFT and its manufacure they are still responsible for the activity and it should be within the scope of their accreditation.

I thought perhaps the RNS had sloppy wording. But no. This is the BSI site scope for Avacta's ISO 13485:-
"The manufacture and distribution of Affimer reagents for use by third parties for Lateral Flow, ELISA and immunodiagnostic in-vitro diagnostic devices."
Not quite the design and manufacture of devices etc which one might have expected.
The ISO9001 issued by QMS has a scope "THE DEVELOPMENT, MANUFACTURE AND SERVICES FOR VETERINARY TESTS AND PRODUCTS, INCLUDING THE PROVISION OF ALLERGEN-SPECIFIC IMMUNOTHERAPY AND OTHER RELATED SERVICES." Again not quite what we need here. There may be other certifications but they do not show up on my searches.
I wonder who is advising Avacta on these matters.

This topic may have been posted before, in which case apologies.
On 7 May two tender awards were published for the Manufacture of Lateral Flow Antigen Tests. They were awarded to Omega 374M and GAD 1.2B. Both are required to manufacture products of any specified Test Developer. Govt is funding tooling etc. Browsing the detail, as one does, I see a difference shown below. I recall Mologic and Avacta entered into an agreement where Mologic was to be the legal manufacturer for Avacta. There is also scope for govt IPR to be licensed and used for a product.
I still think that there will be Avacta product manufactured for the NHS. But Avacta’s take will be very small, affimer and a royalty. There are intangible benefits in credibility etc but the sales of Avacta sourced product through distribution will be the most rewarding.
Omega
3.1.9 If so required by the Test Developer, enter into a confidentiality agreement with the Test Developer in relation to the confidential information contained in the Licensed IPR and Licensed Know How and other information provided by the Test Developer relating to the manufacture of the Goods.
GAD
3.1.9 If so required by the Test Developer, enter into a confidentiality agreement with the Test Developer in relation to the confidential information contained in the Licensed IPR and Licensed Know How and other information provided by the Test Developer relating to the manufacture of the Goods;
3.1.10 If so required by the Test Developer procure tha enters into a contract on terms required by the Authority for the Test Developer to grant a licence to Mologic of the Licensed IPR and Licensed Know How to enable it to carry out its obligations as legal manufacturer of the Goods and such other terms as the Authority may require; and
3.1.11 If so required by the Authority procure that enters into a contract on terms required by the Authority to protect the Authority’s Confidential Information and/or for it to licence to the Licensed IPR and Licensed Know How to enable it to carry out its obligations as legal manufacturer of the Goods and incorporating such other terms as the Authority may require including but not limited to an indemnity in relation to any IPR Claim and product liability claims.

https://eandt.theiet.org/content/articles/2021/06/covid-19-accurately-detected-in-samples-from-smartphone-screen-swabs/?utm_source=Adestra&utm_campaign=New%20EandT%20News%20-%20Automation%20FINAL%20-%20NON%20MEMBER&utm_medium=Newsletters%20-%20E%26T%20News&utm_content=E%26T%20News%20-%20Non-Members&utm_term=732195
Is a really ugly link but gives insights into two other methods for virus detection - smartphone swab and air sampling.

Had to run it twice, couldn't read the captions for laughing so hard my eyes were closed. Hilarious

The SP fell dramatically on a delayed final results announcement last year. The reasons for the delay were never clarified. The market reaction was typical. However, the business seemed to be successful. Then they got caught up by DBay and I suspect that relationship has not been what the founders expected. The SP has drifted for a year.
"the status...under consideration" statement in the RNS about the two founders is a bit odd to me. Do not recall seeing such before.

This is my second encounter with DBay in a company. Destroyers of value. Been here since the initial offering. The founders should have realised this could happen. I did, but the share price has not recovered enough to encourage me to sell. With DBay on the board they are in tricky position. Unlikely anyone else will make an offer.

The Toyota link actually ends up with the Flowflex UK home page. Flowflex is connected to a Chinese company called ACON Labs with an HQ in San Diego Ca. https://www.aconlabs.com/
That appears to be a subsidiary of ACON Biotech in Hangzhou, China.
The Azure Institute that performed the verification of the lateral flow test has a website, https://azureinstitute.com/
I did not learn much there but did discover it is co-located with the ACON Labs HQ. ACON holds the MHRA product registration here. The Flowflex LFT product is not available for sale in the US....
The Flowflex site in the UK has the Azure report. https://www.lateralflowtest.co.uk/wp-content/uploads/2021/03/Clinical-Study-Report.pdf
I do not recall seeing Flowflex mentioned in the Porton Down studies but would be pleased to see a link.

Put the FDA links into a comment under the FT's Covid "News you might have missed" section.

67p Jan 2018

I came across this statement which I trimmed a bit.
DAMIEN O'CONNOR, NEW ZEALAND TRADE MINISTER
"New Zealand supports the waiver of IP ….
It is crucial that the waiver not just apply to
preventative vaccines, but it should also cover other medical
tools for COVID-19, including treatments for people who fall ill
and diagnostics to help curb the spread, as originally proposed
seven months ago."…
"For the remaining countries that continue to oppose the WTO
waiver... they must drop their objections and put people’s
health before pharmaceutical profits, and waive IP on all
COVID-19 medical tools, including vaccines."

We have shares in a charity/NPO if this sentiment gathers momentum.

I watched the interview and thought this is much better than I expected, even unto loadsalft imminent. I come back three hours later to find the SP down 22.5p. Usually one can rationalise negative market movement based on over-inflated expectation, really bad performance etc but what have I missed here?

From Reuters

* OMEGA DIAGNOSTICS GP - UK PUBLIC SECTOR CONTRACT
DISCLOSURE
* OMEGA DIAGNOSTICS GROUP PLC - NOTES THAT IN PUBLIC GOVERNMENT
DISCLOSURE CONTRACT IS STATED TO HAVE AN ESTIMATED TOTAL VALUE
OF £374 MILLION
* OMEGA DIAGNOSTICS GROUP PLC - COMPANY STILL AWAITS CONFIRMATION
THAT A COVID-19 LATERAL FLOW ANTIGEN TEST HAS PASSED NECESSARY
PERFORMANCE EVALUATION
* OMEGA DIAGNOSTICS GROUP - THERE ARE NO COVID-19 LATERAL FLOW
ANTIGEN TESTS THAT CAN BE MANUFACTURED BY OMEGA, ON BEHALF OF
GOVERNMENT, AT THIS TIME.

The Affimer binds to the spike protein - "Avacta has generated a large number of Affimer binders to the SARS-COV-2 virus spike protein including Affimer pairs for sandwich assays and Affimer inhibitors of the spike-ACE2 interaction."

https://avacta.com/diagnostics/covid-19/