Member Info for B2HS2L

I think you missed all the debt and property charges we no longer have, (don't you read RNS's?).

If there's positive spin it's that we might not hear as much tosh from you as before.

Experience in designing and validating SNP genotyping assays
Previous experience in pathogen detection PCR assay design

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Note:

Working closely with internal and external collaborators to define the bioinformatic requirements for assays, set timelines and perform design reviews.

Might be a sign of third party work or white labelling or JV's ?

Fresh position: https://careers.novacyt.com/jobs/2182579-senior-pcr-design-scientist

The successful candidate will support the development of diagnostic qPCR kits, using their qPCR design and bioinformatics expertise, in a fast-paced and friendly biotech company with global reach.
Main duties and responsibilities

Developing qPCR assays: designing PCR primers and probes for targeting bacteria, viruses and parasites to contribute towards new product development. Multiple sequence alignments to select a suitable target for assay design, ensuring inclusivity and exclusivity requirements are met.
Curating sequence data and mining public databases for sequence content periodically.
Producing Bioinformatics Files to include in IVD-R Technical Files for new diagnostic kits, ensuring compliance with all applicable regulatory standards.
Contributing to the daily surveillance of SARS-CoV-2 sequence information to ensure Primerdesign CE-IVD assays/kits continue to detect the mutating virus. Reviewing data analysis and monthly reports for regulatory bodies.
Writing scripts in an appropriate programming language to automate routine tasks such as BLAST searches and design reviews.
Working closely with internal and external collaborators to define the bioinformatic requirements for assays, set timelines and perform design reviews.
Owning and delivering on multiple work packages to develop new products project management timelines.
Provide expert technical support for customers when required.
Ensure the completion of research-related documentation (including technical summaries) in line with ISO 13485 and ISO 9001 quality management systems.

Qualifications and experience required

Essential

MSc in a Life Science Subject
Experience of primer and probe design for qPCR and/or other primer/probe-based assays.
Proficient with bioinformatics analysis tools: multiple sequence alignment, BLAST analysis, open reading frame analysis, MAFFT and databases such as SQL.
Understanding of the biology behind genotyping, gene expression profiling, comparative genomics and genetic mapping.
The ability to work well within a team and have excellent written and verbal communication skills, organisational skills and outstanding attention to detail are crucial for this role.
Experience in using a suitable programming language such as Python or Perl.
Desirable
MSc in Bioinformatics, Computational Biology, Genomics or related field
Expertise in mining public databases for genomic sequences.
Expertise in sequence analysis tools for mapping and comparative genomics.
Experience of working in industry, particularly with a customer focus or technical support role.
Experience of working within a quality system is highly advantageous, particularly ISO 13485.
Previous experience in scientific product development or creating complex study designs desired.
Previous statistical data analysis experience would be beneficial.
Experience in designing and validati

Not sure, but I think this would be the Gensig assay required to test for H5N1 bird flu.
Not sure if the requirement to test bird flocks would mean large orders for this assay.
The effect on our bottom line is a total unknown, and not discussed in previous presentations.
£530 for 150 reactions / box, or £3.53 / test
https://www.genesig.com/products/9266-h5n1-bird-flu
https://www.genesig.com/assets/files/path_h5n1_avian_influenza_advanced_ruo_handbook_t_hb10_01_13.pdf

Doc.
FWIW, this seems to be the place Shionogi might officially place news it was on STRIVE.

https://www.shionogi.com/eu/en/news.html#anc-month10

From 03.06.2021 RNS: 'Launch of two new PCR COVID-19 assays' - "genesig® COVID-19 3G is a CE-Marked three-gene assay to detect the ORF1ab, M gene, and S gene targets of SARS-CoV-2, enabling fulfilment of certain international testing requirements, including Fit to Fly Certificate, Test to Release and US Food and Drug Administration regulations."
I recall other nationalities also requiring 2G or 3G capability.

For me this is the same assay the company have just placed inside genesig SARS-CoV-2 Winterplex 3G.
So we had a 1G Winterplex, and in order to satisfy the above potential customers, we had to develop a 3 gene Covid-19 assay within Winterplex, so we should now satisfy many foreign health regs.

Not sure how many manufacturers have a 3 gene Winterplex equivalent, but WHO UNICEF and the NGO's will be interested.

Perhaps we have applied for an EUA for this product from FDA.

A transcript from the 20.07.22 AGM investor Q/A session: DA "We have the broad respiratory portfolio, which includes Covid-19, but we also have developed Winterplex, which goes beyond the pandemic into respiratory testing which is launched and ready for this winter, and that's what we are seeing governments paying interest now looking beyond covid testing into broader respiratory testing.
We already have that product and we continue to develop a Promate version."

Latest from Mandy tonight:

"We can confirm the PROmate version of Winterplex is in development."

Kind regards,
Mandy Cowling
Corporate & Investor Relations Manager

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Still in development, as in not pending evaluation with CTDA yet.
: ¬ {

Good post EXMEX, from which I got this link:

https://www.gov.uk/government/news/significant-milestone-reached-as-extra-2-million-scans-tests-and-checks-delivered-to-bust-the-covid-backlogs

Community diagnostic centres (CDCs) have delivered more than 2 million vital tests, checks and scans for patients, with a further 10 centres now approved, the Health and Social Care Secretary has announced today (11 October 2022).
These centres are busting the COVID-19 backlogs by speeding up access to lifesaving tests.

apologies - We were told in the JULY 2022 AGM investor Q/A session that Promate Winterplex was in development.

Sharestack - The question is whether Novacyt have been stock piling the assay.
The IFU issue 5.01 is dated 04.08.2022, so the freeze on changes to this assay occured prior to this date.

We were told in July 2020 AGM investor Q/A session that Promate Winterplex was in development.
Where is it? -
It's nearly November, labs worldwide want this type of product now.
It's not pending CTDA evaluation as per yesterdays RNS, so we are only going to sell it outside UK?
That isn't likely.

In todays RNS we have:

1 RNS - "Winterplex® 3G is a high throughput multiplex screening assay (with 96 reactions per kit) for the detection of influenza A, influenza B, respiratory syncytial virus (RSV), and SARS-CoV-2 (COVID-19) (specifically the detection of ORF1ab, S and M genes targets) from oropharyngeal, nasopharyngeal OR SPUTUM SAMPLES."

2 IFU issue 5.01, Mandy has confirmed this is applicable to the new Winterplex product:
"The genesig® Real-Time PCR SARS-CoV-2 Winterplex CE IVD kit is a CE marked, in vitro diagnostic, real-time, reverse transcriptase
PCR (RT-PCR) multiplex assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 (ORF1ab, S and M gene targets), Influenza A (Flu A), Influenza B (Flu B) and Respiratory Syncytial Virus (RSV A and B) in COMBINED OROPHARYNGEAL / ANTERIOR NASAL SWAB SPECIMENS"
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Worst case the IFU is incorrect.
This is so important to our sales of this assay, that I shall be emailing David Allmond asking for clarification.
A number of posters I have contacted, stated they have no answer from Mandy on this question.
Would you please consider emailing David, so that shareholders get clarity concerning the use of SPUTUM as a specimen for this assay.

I shall also be asking whether plans are in hand concerning a PROmate version.

He's filtered HC. - Hoping to hear from Poidster?

Instructions For Use:

From what I think to be the prior Winterplex IFU issue3:
https://www.genesig.com/assets/files/genesig_real_time_pcr_sars_cov_2_winterplex_assay_ce_ivd_ifu_issue_3_00.pdf

"RNA isolated and purified from nasopharyngeal or oropharyngeal swabs is reverse transcribed to cDNA and subsequently amplified using a validated Real-Time PCR
instrument:

genesig® q32 Real-Time PCR instrument, or
BioRad CFX Opus Real-time PCR Detection System (Maestro software 2.0, version 5.0)."

From present Winterplex IFU issue 5:
https://www.genesig.com/assets/files/genesig_real_time_pcr_sars_cov_2_winterplex_assay_ce_ivd_ifu_issue_5_01.pdf

"RNA isolated and purified from combined oropharyngeal/anterior nasal swab specimens is reverse transcribed to cDNA and
subsequently amplified using a validated Real-Time PCR instrument:

genesig® q32 Real-Time PCR instrument,
Bio-Rad CFX Opus Real-time PCR Detection System (Maestro software 2.0, version 5.0),
Roche LightCycler 480 II and
Qiagen Rotor-Gene Q thermal cycler."

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ie. Swabbing and applicable instrument changes.

..So R&D have been busy after all :¬}

So do any doctors on here know if the following new instruments are used widely in the NHS?

Roche LightCycler 480 II and
Qiagen Rotor-Gene Q thermal cycler.

Er, well they've never mentioned it. It's not in any presentation or transcript. But it 's not impossible.
There was or is LFT expertise if Microgen. Developing one would be the easier bit, but production may have to be outsourced, unless the equipment to manufacture was to be made available.

New post advertised:
https://gb.bebee.com/job/20221025-b9a9eb37e5149186538bf794e1431800

neilrich3 - Sarah Humphreys rather enlightening resume on LinkedIn:

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Head Of Sales - Clinical, UK & IHead Of Sales - Clinical, UK & I
Novacyt Group · Full-timeNovacyt Group · Full-time
Feb 2022 - Present · 9 mosFeb 2022 - Present · 9 mos
Reporting into EMEA, brought in to build the UK & I sales team from 3 to 7 team members, to focus on a hunter-gatherer model though 2022, transitioning team to an Account Management model in 2023

Leading a sales team selling a portfolio of molecular diagnostic PCR and lateral flow products across to the NHS and private laboratories, engaging with clinicians, lab team members and procurement.

Agile working required to reverse declining revenue due to the relaxation of COVID testing regulations and support the team in pivoting customers to new portfolio within a competitive established market

Established much needed internal processes to improve the customer experience by re-organising cross functionally to reflect the customer experience – Sales, Customer Service, Technical & MarketingReporting into EMEA, brought in to build the UK & I sales team from 3 to 7 team members, to focus on a hunter-gatherer model though 2022, transitioning team to an Account Management model in 2023 Leading a sales team selling a portfolio of molecular diagnostic PCR and lateral flow products across to the NHS and private laboratories, engaging with clinicians, lab team members and procurement. Agile working required to reverse declining revenue due to the relaxation of COVID testing regulations and support the team in pivoting customers to new portfolio within a competitive established market Established much needed internal processes to improve the customer experience by re-organising cross functionally to reflect the customer experience – Sales, Customer Service, Technical & Marketing
Skills: Recruiting · Coaching · Change Management · Consultative Selling · Training · Analytical Skills · Customer Loyalty · Time Management · Business Strategy · Teamwork · Customer Experience · Business-to-Business (B2B) · Sales Presentations · Direct Sales · Negotiation · Sales Processes

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She may have been a catalyst for change not a long term hire.

Nice to see activity in USA at last.

Thank you for your efforts Wilson.
The point of the publicity was to jolt the company's marketing team out of complacency.
I hope they are truly aghast at making such a basic error, and I only hope that all of the Microgen products advertised are still available.
I'll be watching to see any changes on that link between now and lab-innovations opening early next month.
The marketing team is not yet the asset it needs to be despite the recent high profile staff additions.
Currently it is as much use as a one-legged man in an *rse kicking competition.

Link here for Twitter users: https://twitter.com/b2_hs2/status/1584280359046258688
Link here for non-twitter users: https://www.lab-innovations.com/exhibitor/novacyt-group/
From this it's evident how far Novacyt marketers are willing to stretch to make the companies presence at the 'UK’s only trade exhibition for the entire laboratory industry' a success, with old brands on display.

54 retirement PAHOO,

QED it works.