Member Info for DugWalker

Https://wadsworth.org/regulatory-programs/regulatory-programs/clinical-laboratory-evaluation-program/about-the-program

"The Clinical Laboratory Evaluation Program (CLEP) seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State (NYS) through on-site inspections, proficiency testing and evaluation of the qualifications of personnel of state permit-holding clinical laboratories and blood banks".

Couldn't be clearer really. It nothing more than a formal process to regulate labs that want to use Laboratory Developed Tests in New York State. It checks the proficiency of the lab and does a basic check that the test does what is claimed. It is not remotely the same as clinical validation at scale which requires a large cohort of patients to be tested to ensure the test functions consistently over all age groups. ethnic backgrounds and genders. For CiRT this will necessarily be a prolonged process as it will be necessary to check the efficacy of immunotherapy treatments for those patients identified as receptive by the CiRT test. It is the lack of this type of Clinical validation that is a major barrier to sales of CiRT and this shortcoming is not addressed by NYS CLEP nor will it be addressed by partnerships with distribution companies.

Norovirus may be 5hit (and puke) Dusty but it ain't as bad as immunotherapy if you are not responsive.

From BBC News.

Trials of a potential norovirus vaccine will see 25,000 patients recruited.

I'm away for a game of golf now peeps.

Feel free to fill your boots with 'cheap' shares if that's your hearts desire.

If your head is telling you otherwise read the NYS CLEP test approval documentation.

NU

True.

But will oncologists use it to make life changing decisions based on a cohort of a couple of hundred? I doubt it very much. Indeed the evidence of all those expensive workshops in the US suggests so too.

Mannan

None so blind as those that will not see.

So true!

K3V.

As I have already mentioned dig deeper!

What this NYS CLeP process requires is that the lab submit documentation to demonstrate that their laboratory procedures and admin are to a required standard. It is validation of those. It does not mean that thousands of tests have suddenly been done on patients at a scale and diversity to satisfy the medical community. Besides CiRT would also require months of follow-up to demonstrate that the tests have accurately predicted immunotherapy outcomes.

NYS CLeP accept the evidence submitted that the test appeared to.work on the very small cohort tested (a couple of hundred if memory serves) but doctors will want evidence from thousands of patients of different ages, ethnic backgrounds etc before the test is deemed clinically validated.

'Laboratory validated' is a much abused term in this industry and that is why this 'final ruling' has been made by FDA. Their next move will be to require full scale clinical trials of future LDT's. This is just an interim step towards that.

NU.

I told you where to look. You need to dig deeper!

NU.

Go read the link.in that document that outlines the test approval requirements. 😉

Pure smoke and mirrors Dusty. Just like the BUPA/London Clinic announcements .

Aimed at me NU?

Then I suggest you read the NYS LiN document and perhaps research the background on the FDA's interest in LDT's.

I asked Burrows about this in one of his webinars months ago 😉

"News digested" following a spike that suggests most retail investors didn't read the NYS CLiN documents underpinning the RNS.

I doubt this announcement will suddenly see oncologists rush to buy CiRT. It seems to me that it is nothing more than a check on the lab procedures used by OBD which is a million miles from. Clinical Validation by a randomised trial at scale with diversity of the cohort.

SCM

AIM is a horrible market precisely because of the tendency for folks to view it as an alternative bookies.

It certainly doesn't serve as a market that encourages new commercially or technologically innovative companies by providing a source of reliable investments into them.

Of course the ridiculously bad management of some companies doesn't help. OBD had every chance of rapid growth and could also have had proper validation of PSE financed and facilitated via the largest trial of prostate screening technologies in decades. Our inept US based management team appeared to be hopelessly unaware until it was too late. For me, that sealed their fate.

Well anyone buying prior to the outcome of their strategic review is either daft or not viewing their buy as an investment. Buying here is just taking a punt that you choose the right colour on the roulette wheel.

The Teodorica news simply reaffirms the Italian government's determination to exploit resources to increase domestic energy security. That in itself is good news for Prospex.

Surely we will get an RNS announcing the outcomes of this imminently. Money is running out fast, and there won't be much time to arrange a car boot sale of IP assets or negotiate partnerships in time to avoid a cash raise or loan notes.

My sense is they will look to grant IP rights to a spin off US business and look for private funding there. Hopefully they will explain how that will generate value for UK investors.

Direct quote from the Trinity website;

" Our research is paid for by our corporate clients and we do not carry out any execution business".

🤣

Laura for goodness sakes do some research. They have been talking about licencing of tests to keep the gravy train moving for such a long time. Claimed to 'be in talks with veterinary industry an age ago.

Nobody wants unvalidated tests.

Only 10% 🤣

Laura.

Opening spread is 16%.

Should I buy? 🤣