United Healthcare Issues Positive Coverage Cxbladder

NZX Announcement
9 April 2021



UNITED HEALTHCARE ISSUES POSITIVE COVERAGE DECISION FOR CXBLADDER
US’ largest healthcare insurer publishes coverage of Cxbladder tests

Cancer diagnostics company, Pacific Edge Limited (NZX: PEB) is pleased to advise that its Cxbladder bladder cancer
diagnostic tests are now covered by United Healthcare, the largest healthcare group in the US.

Effective from 1 April 2021, Cxbladder is now being covered as a ‘medically necessary bladder tumor marker test’, under
United Healthcare’s Molecular Pathology/Molecular Diagnostics/Genetic Testing (Medicare Advantage) - Medical
Policy.

United Healthcare has over 50 million members with more than 5.7 million Medicare Advantage members. In 2019,
UnitedHealth Group had a 14.1 percent share of the U.S. health insurance market, with direct premiums written
amounting to approximately US$107 billion
1
. The organisation partners with 6,500 hospitals and care facilities
nationwide, and more than 1.3 million physicians and other providers.

Including the positive coverage decision issued by the Centres for Medicare and Medicaid Services (CMS) in 2020, more
than 110 million Americans now have coverage of Cxbladder non-invasive, highly accurate tests for the detection and
management of urothelial and bladder cancer.

Pacific Edge CEO David Darling states: “Gaining coverage with the US’ largest insurer is a significant achievement for
Pacific Edge and will be of benefit to millions of Americans seeking better clinical solutions and health outcomes for
bladder cancer diagnosis.

“This positive coverage decision reflects the validation that comes from independent published clinical evidence,
inclusion in guidelines and coverage with other providers such as the CMS. It adds further validation of Cxbladder and a
point of inflexion for other healthcare insurers.”

Jackie Walker, the CEO of PEDUSA, Pacific Edge’s US business, said: “Over the last six months, we have been expanding
our US sales team to deliver on the growth opportunities available to Cxbladder. These specialist sales people will now
be working closely with urologists associated with United Healthcare to encourage and support them in their use of our
Cxbladder products.”

ENDS

For more information contact:

David Darling, Chief Executive Officer, Pacific Edge Ltd, P: +64 (3) 479 5800
For media assistance, please contact: Jackie Ellis on +64 27 246 2505 or email jackie@ellisandco.co.nz





1
https://www.statista.com/statistics/216518/leading-us-health-insurance-groups-in-the-us/

NZX Announcement
9 April 2021


OVERVIEW www.pacificedge.co.nz www.pacificedgedx.com
Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer diagnostic company specialising in the discovery and
commercialisation of diagnostic and prognostic tests for better detection and management of cancer. Its Cxbladder suite of
non-invasive, simple to use and accurate diagnostic tests provide actionable results, and better detection and management of
urothelial cancer. The company is developing and commercialising its range of Cxbladder bladder cancer tests globally through
its wholly owned central laboratories in New Zealand and the USA. The company’s products have been tested and validated in
international multi-centre clinical studies.

ABOUT Cxbladder Triage www.cxbladder.com
Cxbladder Triage combines the power of the genomic biomarkers with additional phenotypic and clinical risk factors to
accurately identify patients with haematuria who have a low probability of bladder cancer and may not require a more
extensive urological evaluation. Cxbladder Triage is a tool for use by clinicians and physicians in primary evaluation of patients
with haematuria and is intended to reduce the need for an expensive and invasive work-up in patients who have a low
probability of having urothelial carcinoma.

ABOUT Cxbladder Detect www.cxbladder.com
Cxbladder Detect enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of a
patients’ urine. Cxbladder Detect provides clinicians with a quick, cost effective and accurate measure of the presence of the
cancer as an effective adjunct to cystoscopy.

ABOUT Cxbladder Monitor www.cxbladder.com
Cxbladder Monitor allows urologists to monitor bladder cancer patients for recurrence of the disease. Bladder cancer has a
recurrence rate of 50-80% and requires life-long surveillance. Cxbladder Monitor accurately identifies patients with a prior
history of urothelial cancer (UC) whose Cxbladder Monitor score shows that they have a low probability of recurrent urothelial
carcinoma. Cxbladder Monitor is designed to be used as the preferred adjunct test to cystoscopy in the management of patients
for ongoing evaluation of recurrent bladder cancer.

ABOUT Cxbladder Resolve www.cxbladder.com
Cxbladder Resolve identifies those patients who are likely to have aggressive or more advanced bladder cancer. Cxbladder
Resolve, when used as part of the primary evaluation of haematuria and/or in conjunction with other Cxbladder tests (Triage,
Detect), is designed to assist clinicians by accurately identifying patients with a high probability of having high grade or late
stage bladder cancer, for whom alternative or expedited treatment options may be warranted, or who can be prioritised for
further investigation in high throughput settings.

Refer to www.cxbladder.com for more information.