PEB - Pacific Edge Ltd

**Markymarknz** · 31-03-2016, 12:38 PM

Originally Posted by When the bass drops

CJ, you need to be a paying subscriber to read these. Are you able to provide a better link or explain the jist?

Google "canterbury-moves-to-new-tool-in-bladder-cancer" then click on top link, seems to work fine for me by doing that...

**When the bass drops** · 31-03-2016, 12:51 PM

Originally Posted by Markymarknz

Google "canterbury-moves-to-new-tool-in-bladder-cancer" then click on top link, seems to work fine for me by doing that...

Thanks. Yes, that works.

**Minerbarejet** · 31-03-2016, 02:07 PM

Here you are, saves a lot of phaffing about.

Canterbury DHB has entered into a 12-month agreement with cancer diagnostics company Pacific Edge Diagnostics Ltd to use its Cxbladder technology, a diagnostic tool that checks urine samples in evaluation of haema*turia (blood in the urine).

The technology may eventu*ally replace the long-established use of cytology to assess urine samples for bladder cancer, Canterbury DHB general manag*er planning and funding, Carolyn Gullery says.

Whether Cxbladder will for*mally replace cytology will de*pend on the 12-month trial and conclusions of an audit of the initial 200 to 500 tests once the system is introduced on 1 April.

Clinical adviser to Canterbury DHB’s planning and funding team, Graham McGeoch, says the introduction of the new technology will not result in a big change for general practic*es. GPs will have to request the new test alongside the other tests they have previously always requested.

As happens now, patients’ urine samples will be collected by laboratory collection centres. In rural areas, practices will be sent a special sample kit for nurses to use; samples will then be couri*ered to Pacific Edge’s laboratory in Dunedin for analysis.

“The biggest change is that this will enable more accurate and prompt diagnosis for peo*ple with bladder cancer,” Dr McGeoch says.

Pacific Edge commercial di*rector Brent Pownall considers Cxbladder a powerful tool for GPs because of its high sensi*tivity. Mr Pownall says this will better assist GPs in deciding whether or not to refer patients for specialist assessment.

Ms Gullery says the move is consistent with the DHB’s strategy to deliver more care in the community, closer to where people live.

Clinical trials have proven Cxbladder is superior to cytolo*gy and Ms Gullery expects more accurate testing will result in few*er patients having to go to hospital for cys*toscopy.

B e c a u s e t h e Cxbladder test is high*ly sensitive, it can rule out the presence of bladder cancer and do away with the need for a cystoscopy – where a specialist examines the lining of the blad*der and urethra – which is cur*rently carried out if there is un*certainty following the cytology.

“This is just absolutely consistent with the direction of travel at Canterbury DHB,” Ms Gullery says. “If we don’t have to send someone to hospital, why would we?”

The technology has the potential to lower overall costs in eval*uating haematuria and detecting blad*der cancer, she says.

“Accessing the Cxbladder technolo*gy is not cheap, but it is still less expensive overall and better for the patient. You get a rapid turnaround of results and they don’t have to have a proce*dure," Ms Gullery adds

Pacific Edge is an NZX-listed company developing cancer di*agnostic and prognostic products for better detection and manage*ment of cancer. Its initial focus has been on the US because of the size of the market, but eventually the company hopes Cxbladder will have a place in New Zealand as a DHB-funded pathology tool.

Christchurch urologist Peter Davidson says local urologists have been involved in evaluat*ing the Cxbladder products for some time, and they support its adoption.

MidCentral DHB began using Cxbladder in 2013, and urolo*gists in the Bay of Plenty and Lakes DHB regions began using it a year later.

**Snow Leopard** · 31-03-2016, 02:11 PM

Originally Posted by Markymarknz

Google "canterbury-moves-to-new-tool-in-bladder-cancer" then click on top link, seems to work fine for me by doing that...

"Whether Cxbladder will formally replace cytology will depend on the 12-month trial and conclusions of an audit of the initial 200 to 500 tests once the system is introduced on 1 April"

I did a guestimate that they would do about 2500 tests over the year (I think based on everybody with micro and macro hematuria) and there would be approximately 100 bladder cancers amongst them).

I always thought 200 tests was rather low to make any form of decision on.

Best Wishes
Paper Tiger

**When the bass drops** · 01-04-2016, 10:32 AM

Originally Posted by Bing

Good news. Funny how the last 2 announcements are not price sensitive but the share price jumps.

On that, you could put any announcement out there and the market may react to it, whether you class as price sensitive or otherwise. A typical disclosure to the NZX may, rightly or wrongly, cause the price to jump 5 cents in that day. The market is a funny old thing.

**When the bass drops** · 01-04-2016, 11:03 AM

Originally Posted by When the bass drops

On that, you could put any announcement out there and the market may react to it, whether you class as price sensitive or otherwise. A typical disclosure to the NZX may, rightly or wrongly, cause the price to jump 5 cents in that day. The market is a funny old thing.

They could announce a picture of a giraffe or Pee Wee Herman and the market may react materially. You just don't know.

**Minerbarejet** · 05-04-2016, 12:09 PM

PI-LBA07

THE DEVELOPMENT AND CLINICAL VALIDATION OF A HIGH

SENSITIVITY URINE BIOMARKER TEST FOR THE

DETERMINATION OF RECURRENCE IN UROTHELIAL

CARCINOMA PATIENTS

Yair Lotan*, Dallas, TX; Jay Raman, Hershey, PA; Shahrokh Shariat,

Vienna, Austria; Laimonis Kavalieris, Dunedin, New Zealand;

Chris Frampton, Christchurch, New Zealand; Henry Crist, Hershey, PA;

Elsie Jacobson, Jimmie Suttie, David Darling, Dunedin, New Zealand;

Scott Asroff, Mount Laurel, NJ; Doug Scherr, New York, NY;

George Adams, Birmingham, AL; Evan Goldfischer, Poughkeepsie, NY;

Jeffrey Thill, Orlando, FL; Joseph Williams, Meridian, ID; Joshua Stein,

New Britain, CT; Paul O’Sullivan, Dunedin, New Zealand

INTRODUCTION AND OBJECTIVES: To develop a high

sensitivity, urine based, gene expression test for the determination of

recurrence of Urothelial Carcinoma (UC) and to assess the performance

of this test for the segregation of patients with a low probability of

recurrence from those requiring further investigation.

METHODS: 1093 samples were collected from 803 patients prospectively

recruited at 11 community and tertiary centres the United States.

Voided urine samples were collected pre-cystoscopy for urine dipstick,

NMP22 Bladderchek, NMP22 ELISA, urine cytology and Cxbladder. Local

cytology and FISH were also collected where available.

Patients were partitioned into either a training or validation set based on

demographic and risk factors. The training set (n¼354 patients) was used

to develop a novel algorithm (Cxbladder Monitor) encompassing gene

expression data and previous tumour occurrence information. Cxbladder

Monitor was validated using an independent validation set (n¼449 patients).

Final model parameters were derived on all data and bootstrap

methods used to estimate 95% CIs and performance characteristics.

RESULTS: Incidence of confirmed UC within the recruited population

was 11%. Confirmed tumour stage was as follows : 64% Ta, 14% T1,

22% Tis. Grade was confirmed as 50% low grade and PUMLMP and 50%

high grade disease. Final model Cxbladder Monitor exhibited a sensitivity of

93% (95% CI 82, 97), outperforming all direct comparator tests and locally

obtained FISH results, across all stages and grades of tumour; see table 1.

Cxbladder Monitor demonstrated an NPV of 97% (95% CI: 93, 98).

CONCLUSIONS: Cxbladder Monitor has been developed in

response to the limitations of current urine based tests, and the unmet

clinical need for a high sensitivity, high NPV test to enhance the clinical

investigation of recurrent UC. Cxbladder Monitor demonstrated potential

to rule out those patients with a low risk of having recurrent disease and

therefore to reduce cystoscopy burden on patients undergoing routine

investigation. Use of Cxbladder Monitor could reduce the number of

invasive procedures required for the evaluation of recurrent UC.