Member Info for DugWalker

See you're still pushing you nonsense about OBD needing a US listing. Why don't you tell us all which AIM listed pharmas have a dual listing? It won't take you long. I promise.

A quote from our Chief Scientific Officer.

"While tests like the PSA can be helpful in specific cases, their limited accuracy has prevented the NHS from implementing a prostate cancer screening program in the UK. This is why we fast-tracked the development of the EpiSwitch PSE Test"

I'm sure a few shareholders writing to investor relations to enquire about our interest in a screening trial won't interfere with commercials or materially impact the timing of break even .

Since the last blog on the company website, written by a director, was all about PSE's outstanding potential for national screening programmes the board is going to look a tad silly if they are not actively pursuing participation in a trial on their own turf. I suspect you are right and they will be significantly better informed than me. We might even see the share price tick up if and when they announce our role in the trial.

I have listened GMS and you are right. Peer to peer is the preferred sales route in the US for CiRT and most probably for PSE.

All I'm saying here is that securing wider validation by participating in a properly designed CRT that is funded and that starts next year should be a no brainer. It opens up other sales channels and provides a contingency against changes to legislation in the US that could well have an impact on our dependence on CLIA status. I'm really not sure why this seems to be contentious. There's nothing to lose and lots to gain.

A large scale Community Randomised Trial is the only way to ensure adequate representation of all age groups, ethnicities, symptomatic and asymptomatic participants. The vast majority of men paying for a PSE are likely to be symptomatic. Patient confidentiality is another issue to consider if intending to use data for validation purposes.

True GMS but it's a numbers game too. Look at Stockholm3. More than 75,000 tests done in Scandanavia but it's still specifically included the NSC review (and probably in the Transform trial) on grounds that the Scandanavian trials were not sufficiently diverse from a genetic perspective.

@Dibs

I not sure the FDA would take that view. Basically they are saying tests that have not been fully validated and approved by them are potentially harmful and they are responsible to ensure tests are reliable and approved. That's why they are looking to stop CLIA exemptions.

In any event I think such changes are still some time to become reality but it definately makes sense for companies using CLIA exemptions to develop a contingency plan and there can be none better than validation from a large scale CRT trial, especially if it's externally funded, imminent and likely to be accepted as valid by FDA. Since the technology used is common to the Episwitch suite of tests, a CRT trial for Episwitch PSE might also be seen as validation of other tests if there is some additional supporting evidence, as there would be for CiRT. As you rightly say there will hopefully be many eminent medics willing to vouch for the value and validity.

It's all speculation for now and I only raise the issue because it does provide another good reason why OBD should be getting involved in the screening trials. I suspect they will be actively pursuing participation, I can't see any downside short of the unlikely possibility that the test doesnt work as well for a larger population.

Https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests

Note they are looking to increase regulation of tests, not laboratories. If this legislation comes through then having prior clinical validation would avoid any potential implications. The FDA review has been a long time coming but they are now looking to avoid approval by Congress where it has been a political football. Put simply its another reason why participation in TRANSFORM makes sense.

I know what CLIA exempt means. The definition doesn't change the FDA action. The issue here is will they apply any new legislation they bring in retrospectively? Being clinically validated is a safeguard against that.

OBD's products are there by virtue of CLIA lab exemptions. As I have said (links provided earlier on the forum) the FDA are increasingly concerned that sophisticated tests are getting to market with inadequate regulation in place. They are looking to abolish CLIA exemptions.

Thanks Steve!

Budgets, partnerships and work.programmes for TRANSFORM are being established now. Can't imagine a better time for OBD to get involved.

Since the FDA are fixated on the abolition of CLIA lab test exemptions, clinical validation is an important safeguard for future markets both in the UK and the US. Participation in a national screening programme is the quickest most cost effective way of getting there.

Hi Steve,

I have written to them twice. First time I asked explicitly about involvement in Transform and got the standard 'news announced via RNS' response. I tried again simply asking for their thoughts on TRANSFORM and they chose not to reply. I had hoped they would have said something to the effect of 'we are aware and welcome efforts to introduce a national screening programme', but nothing.

Shareholder pressure can do no harm here.

It seems to me that the door to participate in Transform is open and we simply need the company to walk through. I cannot imagine why they would not. It would be negligence on the part of the board to ignore an opportunity to quickly get clinical validation and I don't believe they are negligent.

So we make private sales now, adding to the growing revenue stream from CiRT whilst leveraging a National trial funded by charity and government to hopefully emerge as the first accurate screening technology for a cancer that impacts 1 man in 8. That would not only transform screening, it would transform OBD to a premier league player in pharma diagnostics.

Contact OBD to press for their involvement and get your wallets our to increase your holdings.

It is clear then that OBD have a route to ensure involvement in the Transform trial. For example they could partner with an NHS trust involved in the PSA element of the trial. There would be negligible additional costs as blood samples will already be available.

The benefits to OBD would be that hundreds of thousands of men from diverse ethnic groups and varying age ranges are to be involved. This will facilitate full clinical validation of PSE and potentially position it as the preferred technology for a National Screening Programme.

Based on this knowledge I have increased my holding back to where it was a week or so ago.

I would still encourage shareholders to contact investor relations at the company to encourage them to participate in the trial. It would be worth mentioning the ongoing review of CLIA regulations that has been initiated by the FDA in the US. Participation in Transform would ensure that OBD is safeguarded against potential changes to legislation in the USA.

Prostate Cancer UK also explicitly state that they wish to encourage partnerships in the trial and that they are aware of companies (OBD?) with promising technologies that require validation via a large scale Community Randomised Trial.

"We are keen to make progress as quickly as possible in this key strategic area of need and believe that the way to do that is to work in partnership as widely as possible. We will continue to have funder-to-funder conversations with relevant organisations but would welcome applicants also exploring and introducing opportunities for partnerships to support this programme.

Partnerships with existing or emerging infrastructure and programmes will be essential to leverage expertise and funding already committed, reduce duplication and, crucially, maximise the likelihood of success.

We are aware that several companies have prostate cancer diagnostic assays that require further evidence from large-scale prospective trials such as this, and we are keen to engage with those companies. We encourage companies who may be interested in this initiative to engage with the charity as early as possible so that we can discuss options and put you in contact with the applicants if relevant".

The relevant quote is;

"We are now seeking to fund this research: a modern trial designed to provide definitive evidence for diagnostic approaches that could replace the current pathway, with flexibility to include or add future interventions or comparisons (or elements downstream of initial diagnosis,such as refinements to our ability to prognosticate or predict optimum treatments), and the collection of biosamples to power discovery and future-proof the trial"..

What you find in the announcement is Prostate Cancer's ambition that the study iis designed to be flexible enough to include future developments that could emerge following the deadline for the call for proposals of August last year.

So following the response I got from the National Screening Committee I did some digging. It transpires that the government representative on the Transform programme is the National Institute of Health Research, not the National Screening Committee.

Here is a link.to the NIHR announcement ofvthe Transform study. It contains a link to the call for proposals that was issued by Prostate Cancer UK ( the main funders of the study).

Https://www.rds-wm.nihr.ac.uk/prostate-cancer-uk-research-to-transform-prostate-cancer-diagnosis