CMS Recommends US$1,328 Price for Triage Plus

10 September 2025


CMS RECOMMENDS US$1,328 PRICE FOR TRIAGE PLUS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes
today that the recommended final ‘Gapfill’ price for Cxbladder Triage Plus
1
has been published
by the US Centers for Medicare & Medicaid Services (CMS) proposing a US$1,328.32 price –
a higher price than the US$1,018 draft price proposed in April this year.
The CMS price sets the amount Pacific Edge will be reimbursed for all patients with Medicare
and Medicare Advantage insurance for Triage Plus subject to Pacific Edge’s Medicare
Administrative Contractor (MAC), Novitas, providing coverage of the test. The test is currently
listed as non-covered on Novitas’ ‘Genetic Testing in Oncology: Specific Tests (L39365)’ Local
Coverage Determination (LCD), but Pacific Edge is preparing to submit a reconsideration
request for Triage Plus shortly after the publication of the DRIVE Study
2
that is currently in peer
review.
Hematuria evaluation tests currently represent around 83% of Pacific Edge’s total US laboratory
throughput
3
. The US$1,328.32 price is a meaningful increase compared to the US$760 CMS
price of our existing tests and compared to the $1,018 draft price proposed by MolDX in April.
When coverage of Triage Plus is established, Pacific Edge will make migration from Triage to
Triage Plus a priority, noting that Detect tests have already been migrated to Triage tests since
the February 2025 inclusion of Triage in the American Urological Association’s microhematuria
guideline.
Pacific Edge Chief Executive Dr Peter Meintjes said: “We are very pleased that MolDX has
recognized the novelty of Triage Plus in their pricing determination with an increase to $1,328.32
and that CMS has recommended this as a final price. We have invested significant resources
in Triage Plus – a multimodal test that combines DNA and RNA workflows with the outputs
analyzed by a novel algorithm that provides dramatic performance improvement over existing
tests and can be used on a broader patient population to assist clinicians to manage their
hematuria patients as high, intermediate or low risk.
“The resources needed to develop, validate and operate Triage Plus commercially are
substantial, thus necessitating a higher price, but importantly when Triage Plus’ performance

1
Cxbladder Triage Plus has CPT Code 0420U and has not yet completed the administrative name change from
Cxbladder Detect
+

2
Detection and Risk stratification In Veterans presenting with hematuria: Savage S.J., et al (2025) The Prognostic
Performance of Cxbladder Triage Plus for the Identification and Priority Evaluation of Veterans at Risk for Urothelial
Carcinoma: The Drive Study, Abstract submitted to the AUA 2025 meeting.
3
Half year to 30 September 2024.

characteristics
4
are used in our existing budget impact model
5
we observe that the improved
performance characteristics has the potential for even greater savings to the Medicare system
by reducing more unnecessary procedures and allowing clinicians to spend more time and
clinical resources on those who need it most.”
The CMS final price for Triage Plus is still subject to 60 days of notice and comment but is
typically not expected to change, and is expected to become effective from 1 January 2026.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge +64 21 645 643
+64 22 032 1263 richard@theproject.co.nz

OVERVIEW
Pacific Edge: www.pacificedgedx.com
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
25 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.

4
Lotan Y, Raman JD, Konety B, Daneshmand S, Schroeck F, Shariat SF, Black P, de Lange M, Asroff S,
Goldfischer E, Efros M, Chong KT, Huang E, Chua HL, Wu QH, Yeow S, Lau W, Yong J, Eng M. Urinary Analysis
of FGFR3 and TERT Gene Mutations Enhances Performance of Cxbladder Tests and Improves Patient Risk
Stratification. J Urol. 2022 Dec 30:101097 JU0000000000003126
5
Tyson MD, Abouassaly R, Durant A, Smith AB, Seemann K, Shoskes DA. Budgetary Impact of Including the
Urinary Genomic Marker Cxbladder Detect in the Evaluation of Microhematuria Patients. Urol Pract. 2024
Jan;11(1):54-60. doi: 10.1097/UPJ.0000000000000489. Epub 2023 Nov 1. PMID: 37914255.

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.