PEB - Pacific Edge Ltd

[Minerbarejet]

The US is fighting a war with Covid.
A mate of mine pointed out at one stage that when you are fighting a war you will not be waiting around for government or bureaucratic approval on the latest whizbang instead of using your supplied ammunition.
The same applies to PEB, they have the ammunition to deal with Monitoring Bladder Cancer patients away from overloaded medical facilities thereby saving a lot of unnecessary expense and helping reduce exposure to Covid.
I think it has finally dawned on KP, CMS et al that this is a viable option under the current circumstances and I would not be surprised to see a fairly brisk uptake.
If it turns out to be a satisfactory and useful addition under Covid, Monitor could well become the go to application overall once and if Covid ends.

Hope there is enough space at the US Lab - it seems to be in a rather large building so probably no worries there.

[Minerbarejet]

Agree.....would hate to see it happen...but if it does happen I would expect a huge premium on recent prices and pocket the gains.

I believe PEB has the rights to all Cancer research developments conducted by the University of Otago.
Would expect a rather large "over my dead body" from them if that is the case
Cant really see the University of Otago sending their research outside the country to some "BIG PHARMA"

[tango]

I believe PEB has the rights to all Cancer research developments conducted by the University of Otago.
Would expect a rather large "over my dead body" from them if that is the case
Cant really see the University of Otago sending their research outside the country to some "BIG PHARMA"

I don’t see the research going to big pharma as a problem. The University will want the best possible uptake from their research.

[nevchev]

Agree there Nevchev .. I bounced into this one a week or so back, only regret: not buying more

Not to late to get a few more in my opion.I think good news will come thick and fast over the next 12 months but not sure that the sp will stay at these prices for long.cheers

[psychic]

Hi Psychic
This is from an interested bystander in reply to your Monitor results query.

GenomeWeb: Pacific Edge Bladder Cancer Recurrence Test Outperforms Others in Head-to-Head Comparison.

CxBladder Monitor Trial finished in 2016, follow the link and you will see there were 803 enrolled participants.

https://clinicaltrials.gov/ct2/show/...&draw=1&rank=1

If you follow this link:

https://www.cxbladder.com/nz/news/20...ad-comparison/

you will find the associated study, the researchers collected a total of 1,036 urine samples from 803 patients undergoing surveillance for urothelial carcinoma. Of these, 1,016 samples were directly assessed using Cxbladder Monitor, cytology, NMP22 Bladderchek, and NMP22 ELISA.

Many thanks & hi Miner
Yeah I had the feeling that this trial had lead to the Monitorining Study. But I was more intrigued by the entry on the Clinical Trials site that the results had not been posted. The thing for me is that the AUA has just come out saying Monitor should not be used because it requires further validation and (or as?) Specificity had not been reported. (Well, that was my take from it anyway)

Both Primary and Secondary Outcomes from the Trial were to report Specificity (and Sensitivity etc.) It hasn't been. And the AUA seem to want this.

Any ideas why they would not/ could not report on Specificity or what PE are doing about further studies? I know that there was that Study in from the DHB's here in NZ and I 'm guessing that was the one needed for LCD to demonstrate Clinical Utility but it doesn't sem to have satisfied the AUA. Cheers

[Minerbarejet]

Many thanks & hi Miner
Yeah I had the feeling that this trial had lead to the Monitorining Study. But I was more intrigued by the entry on the Clinical Trials site that the results had not been posted. The thing for me is that the AUA has just come out saying Monitor should not be used because it requires further validation and (or as?) Specificity had not been reported. (Well, that was my take from it anyway)

Both Primary and Secondary Outcomes from the Trial were to report Specificity (and Sensitivity etc.) It hasn't been. And the AUA seem to want this.

Any ideas why they would not/ could not report on Specificity or what PE are doing about further studies? I know that there was that Study in from the DHB's here in NZ and I 'm guessing that was the one needed for LCD to demonstrate Clinical Utility but it doesn't sem to have satisfied the AUA. Cheers

The "interested bystander" was quick to respond with the information below.

The published results from Clinical Trial Reference: NCT02700659 were published in the Journal of Urology June 2017.

Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study.


Results:
Cxbladder Monitor showed an internally validated sensitivity of 0.93 with a negative predictive value of 0.97 and a test negative rate of 0.34. Sensitivity was 0.95 for recurrent disease with a high risk of progression (all high grade disease and low grade, stage T1 or greater disease) compared with 0.86 for low grade Ta disease. Subgroup analyses indicated that diagnostic performance was not significantly different in different age groups, or by gender or tumor stage. Sensitivity was not affected by adjuvant bacillus Calmette-Gu鲩n treatment within the last 6 months. False-negative findings were reported in fewer than 1.5% of all samples collected.

Conclusions:
The Cxbladder Monitor test offers combined high sensitivity and high negative predictive value to rule out urothelial carcinoma. This test has clinical utility as a confirmatory negative adjunct to cystoscopy, potentially justifying the postponement/avoidance of Cystoscopic investigations to monitor recurrence in patients.

All good
Miner

[Davexl]

Thank you Miner and "interested bystander" whoever you are...Most reassuring statements...

[nevchev]

Cheers miner.The tide is obviously turning in favour of non invasive diagnostics

[psychic]

The "interested bystander" was quick to respond with the information below.

The published results from Clinical Trial Reference: NCT02700659 were published in the Journal of Urology June 2017.

Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study.


Results:
Cxbladder Monitor showed an internally validated sensitivity of 0.93 with a negative predictive value of 0.97 and a test negative rate of 0.34. Sensitivity was 0.95 for recurrent disease with a high risk of progression (all high grade disease and low grade, stage T1 or greater disease) compared with 0.86 for low grade Ta disease. Subgroup analyses indicated that diagnostic performance was not significantly different in different age groups, or by gender or tumor stage. Sensitivity was not affected by adjuvant bacillus Calmette-Gu鲩n treatment within the last 6 months. False-negative findings were reported in fewer than 1.5% of all samples collected.

Conclusions:
The Cxbladder Monitor test offers combined high sensitivity and high negative predictive value to rule out urothelial carcinoma. This test has clinical utility as a confirmatory negative adjunct to cystoscopy, potentially justifying the postponement/avoidance of Cystoscopic investigations to monitor recurrence in patients.

All good
Miner

Thanks Miner, but If I recall correctly NPV depends on prevelence, we still do not have Specificity and this is what the AUA has said is missing.

[Lewylewylewy]

Does anyone have any opinions they'd like to share around how many tests they expect peb to sell in the next 12 months, given recent developments?