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I'm not surprised the IFU is unavailable larry, - too many trade secrets in there.
IMO this assay is now in use, together with Q32 instruments and the PROmate e484k easy (RUO) assay, in as many research establishments as possible.
Every research lab must have a set of positive swabs marked 'most urgent' for sequencing, and if Co-prep is available, then the efficiency and accuracy with which these labs can sequence has improved, allowing staff to get on with other work.
Automated workflow for Q32's processing a PROmate assay.
Hope they've been stocking up on theses assay's.

Apologies if posted before:

Novacyt video to support virtual attendance at ASHG21 https://www.youtube.com/watch?app=desktop&v=6V-etfFdFJM :

Gemma Stokes: "Sequencing technology has advanced hugely in the last decade.
So one project we're looking into is speeding up nucleic acid detection from around an hour to about ten minutes.
The other project is so that we can detect more assays in one tube, which will give a lot more flexibility to our customers.
Of course our surveillance programme will continue, but we're also looking at ways of automating that completely so that we can focus on these other projects."

+++

NCYT has stated that Co-prep has been developed to further automate and streamline the workflow process of the Company's near-patient PROmate® test.

Gemma Stokes stated "Of course our surveillance programme will continue, but we're also looking at ways of automating that completely"

At the beginning of 2021, 'next generation sequencing' was standard in the industry and took days to get a sampling test processed.

Our SNP-sig assays take < 2 hours to run.

One SNP-sig assay uses the PROmate workflow:

https://genesig.com/assets/files/mm142_issue_2_snpsig_sars_cov_2_e484k_easy.pdf - takes 80 mins (this time includes the PCR set-up and the PCR run time) to process samples in a Q32 instrument, and to date, this is the only SNP-sig test to be based on the PROmate workflow. The leaflet does not say open platform, so the assumption is that Q32 is the only instrument to process this assay.

My theory is that the Co-prep cabinets are suitable for this PROmate assay, and that NCYT is trying to get them out to the following partners:

From RNS 02.02.2021 -
"...Of note, the first three SNPsig® assays are also being deployed to an international consortium of leading academic and public health laboratories in the UK, Europe, US and Latin America7,
assembled by Novacyt to support a global variant diagnostic surveillance study."
Note 7-
"UK: University of B'ham, Cambridge, Edinburgh and QMUL, Europe: Gibraltar; USA: Oklahoma, Texas; Latin America: Mexico, Colombia and / or Dominican Republic"
+++
So does "Of course our surveillance programme will continue, but we're also looking at ways of automating that completely" mean that Co-Prep is part of the process to identify e484k mutations in 80 minutes?

This might also explain that there has indeed been a lot of interest from other sources in acquiring these cabinets, (and for some, more Q32 instruments) to the extent the cabinets are spoken for before any are available for retail, thus derailing the expected launch date last month.

From Full Year 2020 results and Strategy Update:
Strategy update highlights
Novacyt has continued to build on its strategy for delivering long-term growth, with the following organic and R&D growth opportunities identified
· Test menu expansion: Continue to leverage the Company's strong bioinformatics and design expertise to develop tests in three areas of focus
o COVID-19 testing - expanding test menu for new variants and innovate to support testing efficiencies and results delivery
o COVID-19 Plus testing - targeting expansion into closely adjacent areas of COVID-19, and biomarker monitoring to predict COVID-19 progression and to diagnose conditions in affected patients
o Post-COVID-19 testing - addressing unmet testing needs, such as pathogens resistant to antimicrobials, sepsis, and transplantation, for central laboratory and near-patient testing

++++
The first two bullet points are partially addressed, as we were advised that the bioinformatics process was to be automated as a priority on the video recently, and the latest 4,000,000 sequences completed has just popped up on https://twitter.com/Larry64450205/status/1456191791837945856

There is a definite increase in sequencing evident, and I assume that means that automation process is nearing completion, and full focus could move on to the 10 minute PCR test.

Third bullet point, - we have already done a lot of work on Sepsis:
From - Final Results for the year ended 31.12.2019 -

"In addition, during the year, Primerdesign expanded its assay development contract with Immunexpress, Inc., a U.S.-based molecular diagnostic company, with the first FDA cleared host response test for suspected sepsis patients. This is to further support the development of rapid diagnostic assays for the detection of sepsis. Sepsis is a potentially life-threatening complication in which a person's immune system inappropriately responds to an infection by triggering a broader inflammatory response, which could cause damage to multiple organs and ultimately lead to death. Left undiagnosed or untreated, a patient could die within a matter of hours. This contract expansion adds further momentum to our B2B segment and provides further validation of the expertise our clinical assay development service offers."

Oriens1, HarChris -
From 27.09.2021 -
"Chief Executive Officer's Review

Continued strong momentum in H1 2021

Novacyt has continued to experience strong demand for its COVID-19 products during 2021, following its early mover advantage in 2020 and continued innovation, strengthening the Company's reputation as a global clinical diagnostics player. This has been demonstrated by the launch of 18 new products since the beginning of 2021 and the generation of £54.0m in revenues from customers, excluding the DHSC.

Novacyt has continued to drive revenue growth from new customers, particularly in private testing markets which is expected to be a key part of the Company's future success. Alongside strong sales into private testing in markets, such as the UK and Germany, the Company secured, post-period, new or extended supply contracts with non-governmental organisations, including with the World Health Organization (WHO) for the supply of its genesig® COVID-19 tests and UNICEF, where the Company has received confirmation that its existing Long-Term Agreement with the organisation has been extended by 12 months to July 2022. The Group has also signed a new contract with the DHSC under the PHE National Microbiology Framework, as announced on 18 August 2021, for the supply of PROmate® COVID-19 tests to the NHS until 31 March 2022.
"

+++

Private Testing Markets - particularly UK and Germany - Not sure how many contracts would be expected here, - more likely emphasis on generating repeat orders and capturing new customers.

Nature of contracts (post period end) revealed here, but not the value except - "18.08.2021 RNS - The DHSC contract is valued at up to £4.7m and will last until 31 March 2022. There are no minimum purchase levels as part of this contract.

So if DHSC want more than £4.7m of tests on a PHE Framework deal,
1 Company not obliged to announce anything until > £4.7m of tests delivered.
2 Company cannot say what revenue has been achieved before 31 March 2022.
3 The company can then say what revenue prior to 3

+++

From Full Year 2020 results and Strategy Update:
Strategy update highlights
Novacyt has continued to build on its strategy for delivering long-term growth, with the following organic and R&D growth opportunities identified
· Test menu expansion: Continue to leverage the Company's strong bioinformatics and design expertise to develop tests in three areas of focus
o COVID-19 testing - expanding test menu for new variants and innovate to support testing efficiencies and results delivery
o COVID-19 Plus testing - targeting expansion into closely adjacent areas of COVID-19, and biomarker monitoring to predict COVID-19 progression and to diagnose conditions in affected patients
o Post-COVID-19 testing - addressing unmet testing needs, such as pathogens resistant to antimicrobials, sepsis, and transplantation, for central laboratory and near-patient testing

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