Triage Plus Price Set to Lift Pacific Edge's Economics

29 April 2024


TRIAGE PLUS PRICE SET TO LIFT PACIFIC EDGE’S ECONOMICS
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes
today that the draft ‘Gapfill’ prices for Cxbladder Triage Plus
1
have been published by the US
Centers for Medicare & Medicaid Services (CMS) proposing a draft price for the test of
US$1,018.44.
When finalized, the CMS price for Triage Plus sets the amount Pacific Edge will be reimbursed
for all patients with Medicare and Medicare Advantage insurance. This will be 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). Private health insurance companies make
separate coverage and pricing decisions based on their own medical policy and contracting for
a test.
In the Gapfill process CMS asks each MAC to propose prices for any new testing services based
on estimates of the resources needed to develop and run the test, then recommends the median
of those prices as its final price. The seven MACs responsible for processing Medicare claims
across various jurisdictions in the United States have published their draft pricing for Triage
Plus. While Novitas priced Triage Plus at US$1,587.69, due to its agreements with multiple
MACs, the price provided by MolDX
2
is the de facto median price, because MolDX pricing is
used in 28 of the 50 states. The draft pricing for MolDX was US$1,018.44, and subject to public
comments that are due by 28 June 2025, and some possible adjustment based on those
comments, CMS is expected to make that price effective on 1 January 2026.
Hematuria evaluation tests currently represent around 81% of Pacific Edge’s total US laboratory
throughput
3
. The US$1,018.44 price is a meaningful increase compared to the US$760 CMS
price of our existing tests, because it increases the margin and margin percentage per test and
improves the profitability of operating our front-line sales force. When coverage of Triage Plus
is established, Pacific Edge will make migration from Triage a priority, noting that Detect tests
are being migrated to Triage tests effective immediately given the February 2025 inclusion of
Triage in the American Urological Association’s microhematuria guideline.
Pacific Edge expects to submit a reconsideration request for coverage of Triage Plus as soon
as the analytical validation (AV) and clinical validation (CV) studies have been published. The

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

2
MolDX is a coverage and reimbursement program run by the Palmetto MAC that provides unique test
registrations and technical assessments for molecular diagnostics products to which other MACs can
subscribe. The majority of MACs have elected to do so, but Novitas and National Government Services
do not.
3
Half year to 30 September 2024.

AV publication is being reviewed by the submitting authors and the CV publication, the DRIVE
study
4
, has already been submitted for publication.
Pacific Edge Chief Executive Dr Peter Meintjes said: “We are very pleased that both MolDX and
Novitas have recognized the novelty of Triage Plus in their pricing determinations with prices of
US$1,018.44 and US$1,587.69 respectively. 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
characteristics
5
are used in our existing budget impact model
6
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.”
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


4
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.
5
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
6
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.

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.
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.