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the lack of investment by directors stands out, you can't fake that. belief shows but there is something suppressing it, government blocking tests with desktop review, lack of plan, poor plan, undisclosed informal agreement gone wrong with DHSC, enquiry, who knows whatever it is, the Poidster perspective of excellent products hasn't induced the board to invest somehow.
BYP - How can you say this - That's incorrect Nick. I've been saying since November 2020 that Novacyt's communications are appalling. I've never swayed away from that message.
There has been no communication BAD/UGLY or GOOD!!!
I'm not with you Amers! Its very clear that since November 2020, the communications out of Novacyt have been very poor. I have watched this share daily for two years, I can assure that I know about all of their comms and those of similar diagnostics companies.
I half wish we were less squeaky clean then we might win some more contracts (at least with UK Gov)! I'm joking btw, the company's bioinformatics report / general whiter than white approach gives me the resolve you need on days (weeks) like these.
It’s a big blue planet & the U.K. government is just a little ant on the ant hill
DRB I love your optimism but we’re some 52% down on Novembers high. And all that’s happened in that time is a massive wave of covid cases.
How can we not be worried and/or suspicious?
Gazman, I wholeheartedly agree our bioinformatics table with millions and millions of analysis(they should just Rns the table) or Jimmy somervilles lookalike(good singer) whistleblower story!! Which one dyou believe.
Nick smith hi, I don't think the story assists our plight, I in this instance concur with Byp it's all very coincidental.
Kaeren, I would be interested on your opinion on this quote from PE's "expert on molecular biology"
"The ability to pick up one genome copy is NOT the same as clinical sensitivity in detecting true positives"
This is like saying apples are not the same as oranges surely?
No idea not a scientist .
Bullraider go to page 21 of this ifu link
https://www.genesig.com/assets/files/path_genesig_covid_19_3g_ce_sted_ifu_issue_5_00_for_december_dhsc_submission.pdf
Which is from neilrich3 recent post there are various tables but there is mention of what you questioned. Nothing to see here and PE are a bunch of......rascals:))
And in my non scientific opinion this is the passage the "whistleblower" and the scientific commentator are picking on, to a layman like me you can see the explanations for why some samples have been left out by Gateshead nhs
16. Clinical Performance Evaluation
An initial clinical performance validation aimed to evaluate the in vitro diagnostic performance of the genesig® COVID-19 3G assay compared with a comparator assay, TaqPath (ThermoFisher). Combined oropharyngeal/nasal swab samples were previously collected from patients suspected of having COVID-19 at the Queen Elizabeth Hospital, NHS Gateshead, both symptomatic and asymptomatic. These were analysed by TaqPath assay, and the eluates frozen at -70oC prior to the commencement of this study.
493 frozen patient sample eluates were tested, with 415 giving a concordant result with the original TaqPath assay result. The 78 discordant samples were then analysed by a resolver assay, the genesig® Real-Time PCR COVID-19 (CE-IVD) assay. 1 sample was excluded due to a lack of eluate for the resolver assay, 20 samples were excluded as they were below the LoD of the assay under investigation (Cq>34). All other samples were determined to be True Positive (2), True Negative (54), or False Negative (1).
The contingency table below illustrates the total positives and negatives that were used to calculate the Diagnostic Sensitivity (PPA), Diagnostic Specificity (NPA), and the 95% confidence interval (CI) for sensitivity and specificity. Of the 472 samples, 157 gave true positive results and 314 gave true negative results. This resulted in diagnostic sensitivity of 99.4% (95% CI 96.5% - 100%) and diagnostic specificity of 100% (95% CI 98.8%-100%).
Contingency table for genesig® COVID-19 3G Clinical Performance Evaluation – Queen Elizabeth Hospital - NHS Gateshead
Also, upon page 32 they quote the Clinical Sensitivity which Private Eye's one expert suggested was missing.
Interesting that the DHSC submission document is dated 31 Dec 2021 (issue 5), clearly there has been a number of amendments, however does not equate to wrong doing, just that the document has been updated as more information has become available.
I would guess that IFUs have been getting updated recently to support the CTDA desktop review process. Reading the private eye write up and re-reading the initial draft CTDA put forward it looks like novacyt (and other testing companies) will be performing validations and updates to fit in with the new process.
https://publications.parliament.uk/pa/ld5802/ldselect/ldsecleg/40/4003.htm
12.Asked for further information about the new validation process and how it differs from the CE marking process, DHSC told us that:
“The CE marking process is far less rigorous than the CDTA desktop review. CE marking requirements do not specify sample size, sample type (clinical v contrived) or present the raw data from which an accurate assessment of the performance can be made. Many of the CE marked products that have been reviewed previously have insufficient and poor data sets that do not accurately reflect how a test product performs. This data and evidence does not facilitate accurate assessment of the product by the end-user and can be misleading. A common example is “front-loading” of data, whereby the CE marked instructions for use will provide performance data based on a selection of samples with a very high viral load thus the test appears to be highly sensitive but in fact may have a poor sensitivity. Other products have used clinical symptoms as the comparator method rather than a gold-standard PCR comparison. [ … ]
The desk top review is undertaken by an independent expert and ensures the validity and quality of the data used by the manufacturer for their CE mark self-certified claims. The pandemic has highlighted the inconsistency in the data behind such claims; for example using sets of samples that will make the performance of their test look better than if it was used on all samples, or not providing information on how their test works for all Variants of Concern. The data is then compared to defined performance thresholds for different testing technology types, as set within the legislation.”
Wilson I just can't stop laughing at your guessing game about Woody it seems you just love to slate people
Keep up the good work
PI100, sentiment and traders are driving the SP. Fundamentals are sound. I appreciate next week will be an anxious wait but I'm comfortable the accounts will be strong. The Outlook is the key and if they don't give clear guidance then the SP wont sustain any gains. However, just because the guidance might be unclear doesn't mean ncyt won't be growing. Imo they have all the right ingredients to grow massively in 2022.
Have you noticed the name of the IFU document shared by Wilson At 16:15 ?
"For december dhsc submission"
Feels like they want to get approval from dhsc to prove the test works well and has no problem At all ?
Thanks for pointing that out wilson and note from it that the "s" or spike gene detection, on which many tests rely, is 100%,PE is acting on rumour and unscientific "random" conclusions,grasping at straws as usual.The traders love it.
The whole CTDA process appears a well-crafted ploy by government to stop introduction and purchase of British-made LFTs. Remember, the approved LFTs on the temporary protocol register (e.g. $hite like Innova, Flowflex) expire end of Feb 2022 and these never underwent any 'rigourous' desktop testing.
The govt's plan was always to ensure continued purchase of these back-hander Chinese tests until end Feb and then rule that govt-paid free LFTs would stop and businesses can purchase privately if they want but we won't really need LFTs apart from care homes, hospital workers etc as the disease is endemic and we'll just live with it.
By that time, unless a more virulent strain arises, LFTs will be largely redundant, although PCR tests will still be important to identify VOCs etc.
Price purely price , if the UK tests were crap but a quid the govt would have shown favouritism for buy British. IMO