Panel Expresses Support for Urine-Based Biomarkers

23 February 2026
EXPERT PANEL EXPRESSES CLEAR SUPPORT FOR URINE-BASED
BIOMARKERS IN HEMATURIA EVALUATION
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
summarizes the opinions expressed by the panel of experts during the Contractor Advisory
Committee (CAC) meeting organized by Novitas
1
on Thursday 19 February 2026 (US time)
regarding the use of urine-based biomarker tests in the evaluation of hematuria. CACs are
typically convened ahead of developing new or substantially revised Medicare policy.
Pacific Edge considers the weight of the opinions expressed by the panel was a clear
endorsement of urine-based biomarkers as medically reasonable and necessary, and
appropriate for coverage by Medicare. The evidence supporting Cxbladder Triage and Triage
Plus was mentioned regularly throughout the call (most notably STRATA
2
and the Kaiser
Study
3
), and among other things, the panelists called for appropriately validated biomarkers
to be covered for expanded indications beyond intermediate risk microhematuria patients.
Specifically, the panelists noted the value of clinically validated biomarkers for:
• routine evaluation of all risk categories of hematuria to rule out bladder cancer
• reflexive use (after cystoscopy or cytology) when those methods do not yield a result
• limited adjunctive use (at the same time as cystoscopy) in situations where it is difficult
to visualize the bladder due to inflammation, redness or blood, including some cases
of gross hematuria
• repeat use to rule out bladder cancer in patients with recurrent microhematuria of
unknown origin
• providing patients who may be resistant to undergoing a cystoscopy with a non-
invasive and medically reliable alternative
Similarly, the panelists highlighted the logistical and economic benefits of urine-based
biomarkers, particularly when tests are ordered from primary care, including:
• improving the healthcare outcomes for patients living in the 63%
4
of rural counties that
do not have urological care
• prioritizing referral of higher-risk patients to urologists
• earlier detection of bladder cancer through increasing compliance and referral thus
reducing the potential of more invasive disease (MIBC)
5

• better serving women, who frequently have hematuria symptoms dismissed as UTI

1
Novitas is the Medicare Administrative Contractor (MAC) with jurisdiction of Pacific Edge’s laboratory operations
in Pennsylvania
2
Lotan et al., (2024) The Journal of Urology Vol 212 1-8 Jul 2024
3
Filson et al., (2026) doi: 10.1097/UPJ.0000000000000972
4
Nolaszco (2025) Curr Urol. 2025 Jul 7;19(5):357–358. doi: 10.1097/CU9.0000000000000292
5
MIBC is muscle-invasive bladder cancer

2
Pacific Edge Chief Executive Dr Peter Meintjes said: “The clear sentiment from the panelists
was that the sum of the published evidence available to Novitas, and the 2025 update to the
AUA Microhematuria Guideline demonstrate that Cxbladder Triage and Triage Plus
6
are
medically reasonable and necessary under the Social Securities Act and given their
demonstrated clinical utility, these tests would be appropriate for Medicare coverage”
Panelist Dr John Sfakianos, Assistant Professor of Urology from the Ichan School of Medicine
at Mount Sinai in New York, echoing the views of many of the panelists, said: “In the setting
of a primary care office, family medicine office... something like Cxbladder that has a [high]
Negative Predictive Value, I think could be useful because we could avoid referrals that are
not necessary.”
Dr Meintjes said the meeting featured several important and meaningful highlights.
“Many of the comments were notably positive, because they reflect the strength of the
underlying evidence and the genuine clinical need. The support from the panel to use
biomarkers for hematuria patients of all risk categories, including gross hematuria in select
cases; the endorsement of their use to support a wide range of clinical decision making, the
specific endorsement of Cxbladder Triage and Triage Plus and the evidence-based plea for
access to these tests as medically necessary in the management of hematuria patients was
encouraging.”
Dr Meintjes said the dialogue was constructive and balanced, with panelists’ responses to
Novitas’ questions firmly based in clinical evidence, including references to STRATA, the first
ever randomized control trial of a urine biomarker and the Kaiser Study, the largest real world
comparative study on urine-based biomarkers for hematuria evaluation.
“We thank Novitas for lending credibility to the ongoing process of establishing Medicare
coverage policy for urine-based biomarkers in hematuria evaluation. We sincerely thank all
CAC members for providing their expert opinions to advance the standard of care available to
Medicare patients,” Dr Meintjes said.
The panel was comprised of seven urologists and one pathologist
7
covering private practice,
academic institutions, the Veterans Administration and Kaiser Permanente. Dr Megan
Landsverk led the Novitas Medical Affairs Team on the call and asked a series of questions
made available to the panelists and the public in advance.
Pacific Edge noted the panelists were aligned regarding the utility of biomarkers, the strength
of the evidence for urine-based biomarkers, with specific mentions of Cxbladder Triage and
Triage Plus, the need for Medicare to cover the tests (often referred to as “access” [to the

6
Cxbladder Triage has analytical validation (AV), clinical validation (CV), clinical utility (CU) and AUA
Guideline inclusion while Cxbladder Triage Plus has AV and CV, and is yet to be reviewed for inclusion
in the AUA Guideline.
7
The participants were: Prof Yair Lotan at UT Southwestern; Dr Bogdana Schmidt at University of Utah and Salt
Lake City VA Medical Center; Dr Abhishek Srivastava at Atlantic Urology Specialists; Prof John Sfakianos at Mt
Sinai; Urologist Dr Terrance Regan; Dr Jason Hafron at Michigan Institute of Urology; Dr Katy Rezaei at Moffitt
Cancer Center and Dr Chris Filson at the Southern California Permanente Medical Group.

3
tests]), and the desire to implement these tests for maximum impact to patient care by
implementation in primary care.
Highlighting the critical need for non-invasive alternatives panelist Dr. Jason Hafron, Chief
Medical Officer and Medical Director of Clinical Research at Michigan Institute of Urology,
noted: “only 13% of patients with high-risk hematuria actually underwent cystoscopy... so that
is why a biomarker could be so appealing”, meaning that biomarkers are the ideal diagnostic
tool for physicians concerned about bladder banker.
UT Southwestern Professor Yair Lotan, a principal investigator on a number of Pacific Edge
trials, and a member of the committee that wrote the update to the 2025 AUA Microhematuria
Guideline noted: "The vast majority of patients with microhematuria in the US are not getting
referred to urologists or any evaluation whatsoever... the consequence is that many patients
are getting delayed in diagnosis”.
In an unanticipated conclusion of the panel, Dr Lotan initiated a direct appeal to Novitas for
Medicare reimbursement given the clinical significance of these urine-based biomarkers and
several other panelists followed that lead summarizing the clinical significance of these tests.
“We're all used to using markers in prostate cancer for many years. There's quite a plethora
of them. If you look overall, they don't perform as well as most of these urine markers, but they
have been widely available.... we are all fairly frustrated when we find this disease [bladder
cancer] late and these patients don't do well because this is a very aggressive cancer,” Dr
Lotan said.
“So, I'm very hopeful that this [session] does lead to access to these markers, which I do think
will help identify this disease early. Most of our patients accept cystoscopy, but prefer not to
have it. And if we have ways to increase efficacy of evaluation and also at the same time
reduce cystoscopy, I think there will be a lot of potential benefits.”
At the conclusion of the meeting, Novitas’ Dr Megan Landsverk said the feedback from the
panelists, alongside the published evidence and the AUA Microhematuria Guideline would be
used to determine if LCD development is warranted.
Pacific Edge does not control if or when Novitas will develop a new or substantially revised
draft LCD supporting the reimbursement of Cxbladder. Pacific Edge maintains the view that
generating compelling clinical evidence in a rigid framework of analytical validation, clinical
validation and clinical utility and the unmet clinical need as articulated by the expert panel
provides Novitas with the appropriate evidence and motivation to develop this policy
expediently. Pacific Edge estimates the timelines for draft coverage are within approximately
six months and final-effective coverage within a further approximately six months, noting
Novitas has up to 12 months from the published draft to finalize or retire any draft LCD.
Novitas is expected to publish a full transcript of its meeting to its website in the coming
months.
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
Pacific Edge: www.pacificedgedx.com

4
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the
way in the development and commercialization of bladder cancer diagnostic and prognostic
tests for patients presenting with hematuria or surveillance of recurrent disease.
Headquartered in Dunedin, New Zealand, the company provides its suite of Cxbladder tests
globally through its wholly owned, and CLIA certified, laboratories in New Zealand and the
USA.
Cxbladder: www.cxbladder.com
Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with microhematuria and those being monitored for
recurrent disease. The tests help improve the overall patient experience, while prioritizing time
and clinical resources to optimize practice workflow and improve efficiency.
Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
30 peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned
studies designed to generate further clinical utility evidence.
Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.