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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.
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.
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/
The Department of Health has chosen Omega Diagnostics, SureScreen and Global Access Diagnostics to produce up to 2m lateral flow devices (LFDs) per day for the UK, according to two people briefed on the decision. In a separate development on Sunday the government announced that SureScreen would supply 20m tests on top of another 2m it procured from the Derby-based company last month.
Will get the SP off to a good start this week....
Avacta's Diagnostics Division works with partners world-wide to develop bespoke Affimer reagents for third party products. The Company is also developing an in-house pipeline of Affimer-based diagnostic assays including the AffiDXTM SARS-CoV-2 Lateral Flow Rapid Antigen Test and a BAMSTM SARS-CoV-2 Assay in partnership with Adeptrix Inc.
FDA just approved Ellume’s mid-turbinate nasal swab Covid-19 home test. Antigen test correctly identified 96 per cent of positive samples and 100 per cent of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91 per cent of positive samples and 96 per cent of negative samples.
https://www.ellumehealth.com/products/consumer-products/covid-home-test
Small print says “Not available in Australia” on another page.
A blue-tooth connection to a phone is required to get the result. Interesting…