Member Info for DugWalker

One small but important addition. The NSC document mentions 'recruitment', in the context of the patients, to begin autumn 2024. When the response to you mentions recruitment might they mean patients or is it definitely a reference to research organisations/companies?

You couldn't per chance copy the reply you got in here? I'll happily do the same if and when I get a reply from NICE.

@JimiHendrix

Thanks for that info. Very helpful.

The problem I have or had is that the information about Transform is very ambiguous. The NSC link I posted this morning talks about an annual call for proposals and the six sub-groups identified for inclusion in the programme apparently derive from those proposals. The budgets have been proposed by those submitting the proposals and budget negotiations are either underway or will take place soon. My direct experience as a reviewer of research proposals (core science not medical) is that once the call for proposals is closed that is it! You can't submit a new application for funding thereafter.

If you are saying Prostate Cancer UK are explicitly saying OBD could still be included that would be great news because I have been consistent in my view that the science/technology behind episwitch seems sound and extremely promising.

"...if I was a doctor in the us..."

Enough of the nonsense indeed.

I just said the doctors wouldn't be the ones signing a disclaimer. What's so difficult for you to grasp here?

Correct Fangkat. Typing on a phone and cap locks didn't activate. Dyslexic fingers but didn't think that would be hard to realise.

It's not a claim its a potential scenario and what is your basis for ruling it out?

Good for you uncle. Except I said it was the doctors that might demand a disclaimer not the patients.

True Krull and if I was being threatened with a biopsy I'd want as much justifying info as possible. Would medicare pay for 3 tests though? I don't know.

Of course I'm aware of the potential rewards if a decent market share is attained and purely from a technical perspective, I have already pointed out that PSE looks a better option than PSA, MRI or Stockholm3. If however they get validated with much larger cohorts they pose a real threat to the commercials.

dibs,

you clearly misunderstand my point. given the highly litigious nature of society in the us i can't envisage a clamour from doctors to recommend their patients rely on a test ( pse ) that is only partially validated and where the evidence that it works for all ethnicities and age groups is sp****. fall off your chair if you like, but if i was a doctor in the us and a patient insisted i base his treatment plan on a pse test that i considered inappropriate to them( pending further validation), then i'd either tell them to find another doctor or sign a disclaimer. at no point did i say a disclaimer would be linked to obd's participation or otherwise in a screening trial. what a bizarre notion. lord knows how you jumped to that conclusion.

nor have i said obd has changed strategy. i do however believe pse would be a significantly easier sell if us doctors had the comfort that the british regulators thought the technology merited inclusion in the biggest screening trial in decades.

if you think us oncologists are unaware of stockholm3 or advances in mri imaging i'd love to know what you base that assertion on.

@Sitain.

I sent the below to Medtech at Nice Monday morning. As yet no response.

Dear Sir/Madam ,

I note that NICE has developed an MIB for Stockholm3 and that this blood test is specifically mentioned in the NSC's preliminary list of technologies to be included in the TRANSFORM study of potential screening technologies for prostate cancer.

I am concerned that there is apparently no consideration being given to the inclusion of Oxford Biodynamics' Episwitch PSE blood test in the TRANSFORM study. Episwitch is a British precision medicine technology and the initial results from the PROSTAGRAM study indicate that it is 94% accurate and that it may well prove to be significantly superior to both MRI and Stockholm3 options.

I would appreciate your thoughts in relation to what appears to be a startling omission or oversight in relation to this apparently ground breaking technology

Luke,

Suggest you read the forum posts Iver the last few months. I have been a very strong advocate of the technology . I frequently defended/promoted it by highlighting information that was apparently not known to others. I have done nothing different today. I believe in the technology, but have reduced my holding because of the info in the NSC blog posted yesterday. Nobody else in here seemed aware of it. So make up your own mind, stay invested or sell, but don't complain about folks highlighting information that has a bearing on the company's ambitions. It does you no justice.

GMS.

For info Stockholm3 is reported to have been validated on 75 000 men in Scandanavia yet the NSC want to see it tested on a more diverse cohort and say they will recruit hundreds of thousands to Transform. The men will sign up to the project and agree that data arising can be used for research/validation purposes.

I don't see how OBD compete with that by commercial sales to individual agents and doctors since patient confidentiality would be a significant consideration

They need to be part of a proper Cluster Randomised Trial to do that and Transform has come to early for them.

I agree CiRT is now more than ever. OBD's lead offering, but until they demonstrate substantial and sustained sales the fact is the company is loss making. I had hoped PSE would help improve finances in the short to medium term but I no longer believe it has the potential it had when first launched. To my mind Transform is a huge blow to the company's ambitions for one of its showcase products. As I said, I continue to have a (significantly) reduced holding in recognition of the potential for CiRT and other products in the product development pipeline. The Transform story is so typical of the risk of investing in AIM.

404.

I was posting about the Transform project weeks ago. Specifically in relation to.the inclusion of Stockholm3 which is a competitive blood test already adopted in Scandanavia and tested on thousands of patients. Yet there it is on the Transform project list because the NSC think.it needs further validation via ethnic diversity.

Look at the link.I posted. The call for proposals was back in 2022 and ended in August 2022. Submissions were asked to specify budgets so the proposals are very specific, have already been peer reviewed and we ain't included!

Hi GMS.

I do agree they have said focus would be the US. However they were too late to submit a proposal to the biggest screening review in decades so it is no surprise that they have shifted focus elsewhere.

My fear is that if patients ask their doctors to get them a PSE the doctors will state that this test isn't fully validated nor is it included in the Transform review. Maybe in the US they will ask patients to sign a disclaimer?

I agree about CiRT and that's why I have kept a smaller holding. I just think the share is now overvalued as to my mind they have a major uphill battle ahead to get market acceptance of PSE. That's a crying shame.

As you know I have been a string advocate of the technology, but there are other factors to consider and missing out on the Transfom project is a significant blow for commercialisation of PSE.

Best of luck moving forward.

Good luck

@Luke

Double edged sword Luke. PSE is not fully validated. It will be a very long time before they can match a cohort of hundreds of thousands if reliant on individual sales through the website.

There's nothing to prevent the company issuing a statement to the effect that they welcome the launch of a review of screening options. The 6 studies have been peer reviewed and retrospective inclusion of ta technology from a company that did not submit a proposal is most unlikely.

I change my mind. What do you do?

I had previously harboured a misconception that the National Screening Committee would have the ability to select tests for inclusion in the Transform study and that PSE would be involved. The following link clarifies that there was in fact a call for proposals followed by peer review that has led to the list of 6 objectives/studies to be included in the trial.

Https://nationalscreening.blog.gov.uk/2023/11/20/uk-nsc-welcomes-major-new-prostate-cancer-screening-research/

Note that OBD's Episwitch is not included in the list of projects to be funded. The call for proposals

closed before OBD published the prostagram results for PSE back at the beginning of this year.

OBD have apparently missed out on an opportunity to validate PSE via a trial that is expected to involve hundreds of thousands of men. The company's silence since the announcement of the Transfom project may be an indication that they are aware of the potential consequences. Had it been otherwise I would have expected an RNS by now.

In light of this I have now sold the majority of my stake in the company. My reasoning is that roll out of PSE in both the UK and the US will be severely hampered by its absence from the Transform study. I expect doctors will be reluctant to endorse the use of PSE to patients when it is not included in this major study and other options such as Stockholm3 or mpMRI will be available (particularly in the UK).

My sense is it now difficult to justify the rise in SP that followed OBD's announcement of the launch of PSE. I have retained a smaller holding as it is still possible that CiRT will transform the company's finances in the coming year or two.

I'm very disappointed by this turn of events. I still believe that PSE is probably the best screening option out there, but sadly it has been overtaken by events.

Https://intheloop.oxfordbiodynamics.com/blog/time-to-rethink-prostate-cancer-testing-a-q-and-a-with-obds-cso-alexandre-akoulitchev-phd-frsm?utm_source=social&utm_medium=blog&utm_campaign=nov-post

Only recently posted. I wonder if the company knew an announcement about Transform was imminent?

The comments about MRI are especially noteworthy.

On what grounds do you conclude that a single paper about mpMRI means there will be no room for PSE in the Transform study?

First of all the announcement of Transform makes it clear that 'other screening methods' WILL be part of the study.

Secondly had you done your research more diligently you would be aware that the very preliminary selection of technologies already listed by the Naional Screening Committee already includes the Stockholm3 blood test which is an advance on PSA but that is inferior and cannot match the Prostagram study results for PSE. Since a blood test is likely to be included why would the NSC preclude the most recent and most promising blood test available? Samples of blood will be readily available at no additional cost.

Finally the UK lab of OBD will have ISO certification early in the new year and OBD's collaborators include the imperial college NHS trust. Quite frankly it will be astonishing if PSE is not on the final list of technologies when it is released.

Your welcome Prion.

By the way the downloadable requisition form to order a PSE test gives the UK price as £750.

Unless the mpMRI improves significantly the cost to the NHS will be substantial due to biopsies linked to false positives.