Proposed Directors of Tirupati Graphite explain why they have requisitioned an GM. Watch the video here.
BioServUK (a Calibre Scientific, Inc. company) continues its successful partnership with Avacta Life Science in distributing their high-performance AffiDX® SARS-CoV-2 Lateral Flow Test which is developed and manufactured in the UK, based on their proprietary Affimer® technology.
Top Features of the Lateral Flow Test:
- 98% sensitivity
- 99% specificity
- CE IVD marked
- MHRA registered
- Patient-friendly: Anterior nares (nasal) swabs samples for a more comfortable collection
- Monitored against emerging Variants: Proven to detect the new Delta variant (B.1.617.2) as per a recent study
- Rapid & Simple: Easy to use, simple work-flow, results in only 20 minutes
Ordering Information:
Product code: BSV-COV-11711125
Product name: AffiDX® SARS-CoV-2 Antigen Lateral Flow Test
Pack size: 1 Pack (25 Tests)
https://lnkd.in/g9YfCrk
info@BioServUK.com
+44 (0)114 224 2235
LFT’s, what do we know?
There are currently 3 LFT’s approved by HMG, (Roche, Life Technologies, Clent Life Sciences).
The 3 approved LFT’s are made by companies based in the USA.
Each of the 3 companies has a UK operation.
The tests were only approved during October 2021, (approx. 4 weeks back).
There are no Chinese tests approved at this time.
Avacta
Data for CTDA and HUA was submitted prior to 1st September 2021.
Avacta approval is pending. Possibly imminent.
When Avacta is approved, demand will be considerable.
Manufacturing capacity is in place to meet UK, European and global demand.
LFT sales will support Avacta during this important development and growth period.
This can only go one way? We are nearly there?
@Nickmc, Bella6532, Howzaty
All rants forgiven.
Many people, not just on this board, feel exactly the same.
The UK needs more commercial people with manufacturing backgrounds making more these important decisions and policies. We should encourage more heading to Uni to study engineering, science, medicine.
@Mr Adventurous
Possibly conflating, possibly asking an important question?
No source, but I do have direct experience in the medical diagnostic market and have experience of the CE (Conformitè Europëenne) mark being abused by overseas suppliers.
A number of tests do not meet their specified performance figures and, for me, that’s raises the question, what else is not correct? If all the current tests are reviewed, the manufacturers supplied documentation will confirm either full CE (Conformitè Europëenne) or CE (China Export). The question needs to be asked.
Sadly, where there is an opportunity for money to be made, there will always be unethical opportunists.
@Timster
Government has published a list of approved tests that includes many from China with a CE (?) mark. Wonder if they will publish a list of tests that are failing to perform and are causing concern.
If they did, …… MASSIVE month could come before Christmas?
We have multiple LFT’s that are CE marked (Chinese Export) but don’t achieve what they claim. These tests will be suspended from February 2021, (if not before).
https://www.gov.uk/government/consultations/validation-of-covid-19-tests-laboratory-validation/validation-of-covid-19-tests-laboratory-validation
https://support.ce-check.eu/hc/en-us/articles/360008642600-How-To-Distinguish-A-Real-CE-Mark-From-A-Fake-Chinese-Export-Mark
Meanwhile, Germany Struggles with Covid:
https://www.worldometers.info/coronavirus/country/germany/
Austria is considering a lockdown for unvaccinated while numbers rise.
https://www.bbc.co.uk/news/world-europe-59245018
Covid has not gone away and accurate LFT’s offer a means to monitor infections efficiently. Avacta has capacity in place and is adding to this. We also have HUA pending.
No RNS today but there will be major news relating to LFT’s approvals / sales along with AVA6000 life changing performance shortly.
Current share price is painful but, IMO, this is only going one way.
Have a good weekend and DYOR, ;-)
What does CE approval mean?
On commercial products, the letters CE mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark.
Extracted from: https://www.gov.uk/government/consultations/validation-of-covid-19-tests-laboratory-validation/validation-of-covid-19-tests-laboratory-validation
“Prior to the introduction of the new validation regime, entry into the SARS-CoV-2 (COVID-19) test product market was controlled by CE marking alone. This means that manufacturers of self-certified devices will affix the CE marking to their devices, without any independent audit or conformity assessment from another body, either a UK approved body or an EU notified body.
The performance declaration made as part of CE marking is not required to be independently verified ahead of sales.
Evidence has shown that a significant number of COVID-19 tests have failed to replicate their stated performance”.
This is criminal!
If there is money to be made, there will always be opportunist who will produce rubbish and put a CE mark on it. Avacta will obtain UK approvals soon and we will have an LFT product that works.
For our friends in Asia, CE = Chinese Export
Germany Struggles with Covid
https://www.worldometers.info/coronavirus/country/germany/
Avacta can sell in to the German market while waiting CTDA & HUA.
Medusa 19 are exhibiting at the Medica Fair in Dusseldorf next week.
UK sales restricted at the moment but there are other greater opportunities for the best LFT’s
11th August 2021
https://avacta.com/avacta-announces-first-patient-dosed-in-ava6000-pro-doxorubicin-phase-1-clinical-trial/
Avacta Group plc (AIM: AVCT), is pleased to announce that the first patient has been dosed in the Company’s Phase I multi-centre trial evaluating AVA6000.
Avacta’s pre|CISION™ pro-drug approach is designed to reduce the systemic exposure of healthy tissues to the active chemotherapy, leading to improved safety and therapeutic index, potentially resulting in improved dosing regimens, better efficacy and better outcomes for patients.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented:
“The initiation of the first in human Phase I clinical study for AVA6000 marks the transformation of Avacta into a clinical stage biopharmaceutical company.
“We are delighted to be working on the AVA6000 study with global key opinion leaders in oncology drug development at world-class oncology clinical trial sites in UK on this important pro-drug approach to improving the safety and efficacy of chemotherapies.
“If the study shows that the pre|CISIONTM technology is effective in reducing systemic toxicity of Doxorubicin in humans, then that would open up an extensive and proprietary pipeline for Avacta of next-generation pre|CISIONTM pro-drug chemotherapies with significant clinical and commercial advantages in a chemotherapy market that is expected to exceed $74 billion by 2027.”
Comments:
It is now almost 3 months since the patient was dosed.
No news, (positive or negative). The trials escalate and continue.
This is ground breaking science which will make a major difference to so many people who are suffering from cancer.
It is life changing, lifesaving and a multi $bn market.
https://avacta.com/update-on-uk-availability-of-affidx-sars-cov-2-lateral-flow-rapid-antigen-test-following-implementation-of-ctda-regulations/
As of 1 November 2021, the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA regulations”) have come into force.
The new CTDA Regulations stipulate that all suppliers of COVID-19 tests must submit information regarding their products for desktop review if they wish to remain on sale in the UK.
As of 1 November 2021, there were only 3 products for which the Agency had completed its desktop review listed on the CTDA register for approved products.
Additionally, the UK Health Security Agency has published a temporary protocol which lists 48 tests (both PCR and antigen based) which passed the Public Health England validation process at Porton Down earlier in the year that can remain available for sale in the UK whilst their validation is completed until a cut-off date of 28 February 2022.
Avacta submitted, ahead of the 1 September 2021 deadline, all the information required for its AffiDX® test to be validated under these new regulations. Avacta waits an update from the UK Health Security Agency.
As previously noted, Avacta continues to focus on opportunities outside of the UK for the sale and marketing of its AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test including markets in Europe and further afield.
Comments:
48 tests are being given an amnesty until 28th February 2022. If they do not pass the new criteria, there will be 3 approved products along with Avacta’s best in class test, (subject to approval).
If the other tests fail to meet the new criteria, there will be a shortage of LFT’s requiring the approved tests to increase their manufacturing capacity. This would include Avacta.
AS has stated that Avacta are making direct sales to large corporates, elite sports clubs, travel sector, etc. Avacta continues to focus on overseas sales.
Medusa 19 will be exhibiting at Medica 15th to 18th November. Medica typically attracts 125,000 global visitors.
@Bella6532
"If approvals aren't forthcoming quickly then LFT shortages could be on the near horizon as the 40 odd only have a few months grace period and how many overall approvals will there be when all deadlines are reached..."
Don't disagree and we have been in the queue since 1st September or before.
Should hopefully have CTDA and HUA approvals soon?
The pre|CISION™ and Affimer® platforms
03 Nov 2021
Interview with Fiona McLaughlin – Avacta Chief Scientific Officer, Therapeutics
https://avacta.com/interview-with-fiona-mclaughlin-avacta-chief-scientific-officer-therapeutics/?utm_content=185902177&utm_medium=social&utm_source=linkedin&hss_channel=lcp-3342419
The pre|CISION™ and Affimer® platforms are both very exciting, offering the potential to advance treatment options for patients. I hope to continue to work with the team to bring novel, effective cancer therapies to market, particularly addressing areas of high unmet clinical need, such as pancreatic cancer.
Previously posted but worth the reminder at this time, ..
WHO warns Europe once again at epicentre of pandemic
https://www.bbc.co.uk/news/world-europe-59160525
Europe is once again "at the epicentre" of the Covid pandemic, the World Health Organization (WHO) has warned, as cases soar across the continent.
The WHO's technical lead on Covid-19, Maria Van Kerkhove, said over the past four weeks cases across Europe had soared over 55%, despite an "ample supply of vaccines and tools", and colleague Dr Mike Ryan said Europe's experience was a "warning shot for the world".
It came as Germany recorded almost 34,000 daily Covid cases in the past 24 hours, a record rise.
While the Covid numbers in Germany are below the UK's latest daily case numbers of more than 37,000, public health officials are worried that a fourth wave of infection could lead to a large number of deaths and pressure on the health system. In the past 24 hours 165 deaths have been recorded, up from 126 a week ago.
But as Hans Kluge pointed out, the surge in cases is not confined to Germany.
The most dramatic rises in fatalities have been in the past week in Russia, where more than 8,100 deaths were recorded, and Ukraine, with 3,800 deaths. Both countries have very low rates of vaccination and Ukraine announced a record 27,377 new cases in the past 24 hours.
UK is 1% of the LFT market. The other 99% of the market is our immediate opportunity. There is still a need for LFT’s and we have one of the best.
Trying to digest yesterday’s posts and comments.
Avacta Group PLC and Novacyt SA said (Tuesday) that they have pulled some Covid-19 testing products from sale in the UK, as new regulatory measures come into force. ODX doing the same today.
Can we expect other manufacturers to follow (withdraw)? Timster (07:27) suggested yesterday that only 3 have passed the desk top review so far, (Roche, Life Technologies Ltd, Clent Life Science).
There is a possibility of LFT shortages which will require a push to approve pending (Avacta) tests for personal and home use. HMG should be looking for a UK developed and manufactured product to keep the public safe.
Avacta submitted their application before 1st September. There is also an application for HUA. Will these be receiving priority to bring the best in class LFT to the UK market? Avacta LFT can still be sold to the other 99% of the market.
LTH’s are waiting for news on CTDA approval, HUA and also AVA6000 progress.
Can we of discuss the possible implications (positive or negative) that the new regulations may have for Avacta and other LFT producers? Will there be LFT shortages? Is this a big opportunity to support the UK demand?