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Those two may amount to one and same thing highlandmatt.

My understanding, is that certification comes via the lab being approved by Clinical Laboratory Improvement Amendments (CLIA) (Corepath is approved) and certain analytical validation being done on the test. There is no FDA approval required for a LDT currently (though there are proposals for such that are under consultation and are unlikely to impact ciz this year).

Have a read of this:

CLIA Overview… - CMS https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ldt-and-clia_faqs.pdf

In brief, CLIA "regulates laboratories to ensure accurate and reliable test results when laboratories perform testing on patient specimens."

"The analytical validation under CLIA looks at the performance characteristics of a test used to describe the quality of patient test results, and includes an analysis of accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference interval, and any other performance characteristics required for the test system in the laboratory that intends to use it. This analytical validation is limited to the specific conditions, staff, equipment and patient population of the particular laboratory, so the findings of these laboratory-specific analytical validation are not meaningful outside of the laboratory that did the analysis. "

"The CMS’ analytical validity review is intended to determine if a specific test finds what it is supposed to find (i.e. the analyte it is intended to detect) when laboratories perform testing on patient specimens. Therefore, the analytical validation must be performed by the laboratory intending to use the test on patient specimens. Furthermore, the laboratory’s analytical validation of a LDT is reviewed during its routine biennial survey – after the laboratory has already started testing."

So that reads to me, once the performance characteristics have been determined (there are CLIA guidelines on how that should be done https://www.govinfo.gov/app/details/CFR-2022-title42-vol5/CFR-2022-title42-vol5-sec493-1253), the certified lab can start to use it immediately.

This is my understanding based on reading. If someone with better knowledge thinks this is wrong, do please let me know.

You did miss out this bit, which is relevant i think to the real underlying risk.

"The counterparty’s core business is not that of a software developer or reseller neither the Company nor ARM is aware that the counterparty has sought to access the source code or exercised, or intends to exercise, any of these rights"

Sounds to me like corporate legal messed up here in the past, and your questions are reasonable. If you are concerned, I'd suggest you ask the company.

Like Joe Bloggs?

Agreed Techtonic. Allan says "in the near term". A year wouldn't fit with that.

I've not seen any other biomarker tests for lung cancer being developed, but if you know of others in progress, do let us know. First is good, but Best would be even better. The market should also be large enough for mulltiple solutions.

These things take years, which is one reason I'm confident in Cizzles test - because it has decades of Prof Coverley's research behind it.

It don't think we are too far away now.

Was waiting for Wiiddy to appear, lol.

And yet you're still here Widdy. Still unable to sell up just in case you become the guy who sold and missed the buyout at £1.

Like I said, if I'd waited 3 years, now wouldn't be the time I'd be selling.

I have no timetable, so happy to wait another year if necessary. Its not the like the wider market is doing much better, with a few small exceptions.

Pharma is slow, that's for sure. But the rewards when the outcome is successful are very high.

In a better market, the reduction in risk as each step forward is made might be reflected in the SP and a constant influx of new investors would keep the SP high.

But we're not in that better market. We're in a market with small caps generally down and out of favour across the board, competing for the same restricted set of cash, and many 'investors' now being very risk averse, often having a very short term trader mentality (selling at small losses to avoid larger paper losses). This in turn drops the share price into an uncomfortable for many, even greater 'paper loss' situation, and encourages others to sell, and so the cycle of SP decline continues.

As others have said on this board before, the price is meaningless until the goal is achieved, when there should be a major rerate (though in this market who can tell, there are undervalued companies all over IMO). But large biotech players will know the value of an accurate lung cancer test and i would expect the market to understand that too.

Personsonally I am very bullish about the chances of success. They would not be at the stage of clinical trials and partnerhips with Biotechne if they thought it wouldn't work. In my mind, they are now deep in the mechanics of making it work operationally, protocols, storage of assays, etc. and testing of the accuracy. We just need to let them get on with it.

If the test is commercialised, we know it can work at scale and that in itself is a huge re-rate as it leads to revenue. The extension to an LFT style test would again be a huge re-rate, and at any time someone could decide to buy us.

How long you choose to wait is of course up to you. I have no end timetable at this point. But if I'd waied three years, personally I wouldn't be selling now.

Anyone buying now is getting a bargain IMO. Less tiem to wait, ans still at a price less than our agrees loan facility, should we decide to use it! Incredible.

But the market is sh*t . Ciz was actually one of my better shares today!

Bobat123

"The stock market is a device for transferring money from the impatient to the patient.” WB

Nothing goes up in a straight line. CDT is still in an uptrend, making higher highs and higher lows (so far).

Would need to close at about 2.7p to break thay trend.

I'm relaxed about updates. Only update I need is we have a commercial test, or we've had an offer. I've set an alert fpr an SP over 10p which should tell me when one of those things happens, and an alert for sub 2p (when I buy more).

Agreed AsiaMarket.

The price was higher to buy that volume. One might suspect the sneaky MMs of dropping the price to collect shares in sufficient quantity to sell to the large buyer...

I think we'll see some consolidation between 5 and 6 after Fridays traumatic day for the SP. But 5 looks solid to me. Slow build from there to attempt a higher price.

The gap phsychology will be in play here though, and I still expect a rise over the week to attempt that. But it needs a solid base of buys at higher prices.

My own view is we may find out about the trials when they are finished, since the intention to conduct them is already known. We even know where they will be conducted and have video footage of Alan pep talking their staff! So it wouldnt be material price affecting news.

AS states he won't release news unless its important.

We could of course have news on the progress of the simultaneously developed LFT style test.

An offer for the company might come at any time, but realistically, I think trials would need to be almost done for that too, since any buyer basically wants to know the sensitivity and specificity of the test. As a partner whose machine they are using, Biotechne should know that before anyone else, including us!

And welcome to LSE xyzInvesting 👍

🤣 lol, yeah I dont really buy US stocks. You can tell.

CDT at 10p per share is certainly not priced in. It was expected, and failed to materialise (and might still).

Plus, if it hits 10p,it may not stop there. Sentiment in the US is inproved on the macro, so could go even higher. Regardless, its more liquid funds for ciz.

Just another piece of good news to add to every other piece of good news delivered.

I'm expecting no update until its done. Try buying at 2.25p then :-)

Really strong close on CDT this evening. I think the gap will be attempted next week.

This would be a really good time for CDT to release some news 😉

Sadly Deacs1970, lottery numbers are random, whearas share trading is human psychology.

Mighty strong bounce into the close. That gap is prime target for next week. 🎯

There we are. Bounced at 5.01.

Reset, ready and primed for next week's gap attempt.

👌

MM's running it down to 5. Watch for the bounce.

The volume at 7 looked too weak to support a rise upwards.

There is some support at 6, and stronger support again at 5. The pullback looked inevitable. So far 6 is holding. If it drops further I think 5 will hold and bounce.

No doubt in my mind that we will see an assault on the gap, most likely next week.

This was held at the end of November:

https://investors.bio-techne.com/press-releases/detail/395/bio-techne-to-present-at-the-6th-annual-evercore-isi

But the folowing caught my eye:

"Bio-Techne also develops and manufactures diagnostic products including FDA-regulated controls, calibrators, blood gas and clinical chemistry controls and custom assay development on dedicated clinical instruments. Bio-Techne's genomic tools include advanced tissue-based in situ hybridization assays (ISH) for research and clinical use, sold under the ACD brand as well as a portfolio of clinical molecular diagnostic oncology assays, including the ExoDx® Prostate test for prostate cancer diagnosis. These diagnostic and genomic products comprise Bio-Techne's Diagnostics and Genomics Segment. Bio-Techne products are integral components of scientific investigations into biological processes and molecular diagnostics, revealing the nature, diagnosis, etiology and progression of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2023 and has approximately 3,200 employees worldwide."

Ciz's lung cancer test would be a fine addition their prostate cancer test. And extension to other cancer types would give them a whole suite of cancer tests.

I dont see them on the list of major shareholders on the cizzle website?