PEB - Pacific Edge Ltd

[850man]

How about less waffle and more discussion? Counter my findings, that is why I post. It is healthy to research and discuss these things, it is what the site is all about.

I have argued that the four announcements giving rise to the SP are all misleading and that the market has been duped. Tell us all why I am wrong.

Well said Psychic! Exactly why we should be welcoming opposing views to ensure we have a balance. Sometimes the gloss is too good on the outside to see the rust underneath

[Balance]

PEB needs to get cracking on getting the test numbers in the US up in a big and meaningful way.

Pays to keep an eye on what's happening out there with competitors and potential competitors :

1. Veracyte

https://www.genomeweb.com/reimbursem...e#.YMJ0Dy0Ro6o

https://www.cms.gov/medicare-coverag...AAAABAAAAAAAAA

Veracyte announced on Friday that its Decipher Bladder test for cancer will be covered under a future local coverage determination from Medicare. (LCD to apply from 18 July 2021.)

2. KDx Diagnostics

https://www.360dx.com/cancer/kdx-dia...s#.YMJ3SC0Ro6o

URO17 is a urine-based test that uses the oncoprotein keratin 17 as a biomarker to detect new and recurrent bladder cancer. It received CE marking and a breakthrough device designation from the US Food and Drug Administration in 2020.

https://news.yale.edu/2021/06/04/stu...bladder-cancer

A revolutionary new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine, according to a study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for relapse.

[psychic]

Very interesting , thanks for posting Balance.
I have yet to see any of the Cxbladder tests being specifically approved by CMS as the Decipher test is in this proposed LCD and in what circumstances it should be used.

I know Cxbladder Monitor and Detect have CPT codes, but this is an administrative thing only and does not mean the tests are approved. Admit I don't fully understand this LCD review, but it almost now seems to approve the use of biomarkers when considered medically necessary and if the test has passed the MOiDx Technical approval process. I don't recall Pacific Edge have ever trumpeted this achievement and wonder if any of the tests have it?

[psychic]

From memory NZ gets the tests at a substantial discount to the US hence the financial is very small.

There was a clinical advisor of Hawkes Bay DHB I spoke with about bladder cancer and he said in Hawkes bay there would be very few customers suffering from bladder cancer. Maybe similar in other DHBs

Yes, using ROW (ie NZ) commercial test lab throughput and revenue I get around NZ$245 per test. Do the Americans feel a bit prickly at the US $760 price point when it costs so little to complete?

[850man]

PEB needs to get cracking on getting the test numbers in the US up in a big and meaningful way.

Pays to keep an eye on what's happening out there with competitors and potential competitors :

1. Veracyte

https://www.genomeweb.com/reimbursem...e#.YMJ0Dy0Ro6o

https://www.cms.gov/medicare-coverag...AAAABAAAAAAAAA

Veracyte announced on Friday that its Decipher Bladder test for cancer will be covered under a future local coverage determination from Medicare. (LCD to apply from 18 July 2021.)

2. KDx Diagnostics

https://www.360dx.com/cancer/kdx-dia...s#.YMJ3SC0Ro6o

URO17 is a urine-based test that uses the oncoprotein keratin 17 as a biomarker to detect new and recurrent bladder cancer. It received CE marking and a breakthrough device designation from the US Food and Drug Administration in 2020.

https://news.yale.edu/2021/06/04/stu...bladder-cancer

A revolutionary new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine, according to a study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for relapse.

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

[Leftfield]

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

Thanks 850 - good to have more info' on this.

[Retired Doc]

I put this to PEB's investor Centre and received the following responses:

Decipher Bladder, which is manufactured and sold by Veracyte in the US, is not a diagnostic test in that it does not indicate the presence or absence of disease. Instead it is a prognostic test to identify the likely patient survival benefit from neo-adjuvant chemotherapy prior to surgery for selected bladder cancer patients.

Pacific Edge does not consider Decipher Bladder to be a competitor to Cxbladder, rather completely complimentary. The target customer for ‘Decipher’ is a small subset of bladder cancer patients - those with Muscle Invasive Bladder Cancer (MIBC) and for those that are post-treatment (TURBT) but prior to possible cystectomy. These patients would typically not be candidates for testing with Cxbladder.

The URO17 test (KDx) is still in development and is an immunocytochemistry test that claims a high level of performance (sensitivity), superior to cytology. The mode of operation is to be used in conjunction with cytology. However the development and validation of URO17 has been performed on a small cohort of 179 patients in total (development: n=81, validation n=98) where the incidence of disease is abnormally high (nearly 33%) and does not reflect a real life population. This ‘enrichment’ of the study cohort will invariably overstate the performance of the test and will require further large-scale clinical studies, with prospectively recruited cohorts from real-world patient populations to validate these results. Equally the number of high grade / late stage vs low grade tumours, and the ratio of males to females in this study is inconsistent with what would be expected from a prospectively recruited patient cohort. The overall conclusion is that this single biomarker test has performance that is inferior to Cxbladder.

We don’t consider this level of performance competitive as it is based on a very small study and accordingly the URO17 test does not currently represent a threat to Cxbladder. There may well be other new tests developed over time, however all will have to complete many years and many 10’s of millions of dollars of evidence development to achieve adoption and reimbursement recognition.

Over time, however Pacific Edge continues to observe and evaluate these products on their merits while maintaining our marketing, and R&D efforts on expanding clinical adoption and product improvement (respectively).

Thanks for doing the mahi on that. That is reassuring re CxBladder’s leading position over the competition.

[thegreatestben]

PEB
21/06/2021 09:33
GENERAL
PRICE SENSITIVE
REL: 0933 HRS Pacific Edge Limited

GENERAL: PEB: Kaiser Permanente to Commence Use of Second Cxbladder Test

KAISER PERMANENTE TO COMMENCE COMMERCIAL USE OF SECOND CXBLADDER TEST

Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) is pleased to
announce that it has been informed by Kaiser Permanente that it intends to
commence the commercial use of a second Cxbladder product, Cxbladder Triage,
from the beginning of July 2021.

In June 2020, Kaiser Permanente approved the commercial use of Cxbladder
products by its urologists for patients being evaluated and managed for
bladder cancer. Kaiser Permanente commenced its commercial use with Cxbladder
Monitor for patients being monitored for the recurrence of bladder and
urothelial cancer.

Kaiser Permanente has now informed Pacific Edge that it intends to commence
the commercial use of a second Cxbladder product, Cxbladder Triage for
patients presenting with haematuria (blood in the urine and a key indicator
of bladder cancer).

Kaiser Permanente will start its commercial use of Cxbladder Triage in a
single clinic comprising six urologists. This initial clinic is also using
Cxbladder Monitor. Kaiser Permanente plans to progressively roll out
Cxbladder Triage, alongside Cxbladder Monitor, across their network. Kaiser
Permanente will use Pacific Edge's Patient In-Home Sample System for
Cxbladder Triage, as is currently being done with Cxbladder Monitor,
providing a simple and convenient way for both the patient and the physician
to manage urine sample collection.

CEO of Pacific Edge, David Darling, said: "We are delighted to continue the
growth of our commercial partnership with Kaiser Permanente. Since reaching
commercial agreement with Kaiser Permanente we have focused on working with
them to provide their urologists with a great user experience. This requires
successfully integrating Cxbladder into their internal electronic medical
records systems to ensure that our products and services are easily
accessible to their urologists and patients. While Covid-19 continues to
impact the speed of the Cxbladder rollout across the Kaiser Permanente
network, going forward we expect that their demand for Cxbladder will
continue to increase as Covid-19 related restrictions ease and they expand
the use of the use of two Cxbladder products."

ENDS

[Alpha]

https://www.nzx.com/announcements/374228

[tango]

Woohoo
Just saw this on my email. I have no idea the profit margin on this product but I am seeing lots of $$$

Disc: holding