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PE Receives Approval for New CPT Codes from AMA

Operational Update9 March 2018PEBHealthcare

9 March 2018
Company Announcement



PACIFIC EDGE RECEIVES APPROVAL FOR NEW CPT CODES FROM AMA


Cancer diagnostics company, Pacific Edge Limited (NZX:PEB), advises that the American Medical Association (AMA)

Current Procedural Terminology (CPT®) Editorial Panel has granted Administrative MAAA CPT codes for Pacific

Edge’s Cxbladder Detect and Cxbladder Monitor tests.

The granting of these dedicated codes is a key component of the reimbursement process in the US and will help

with access to the Cxbladder tests for urologists and their patients across the United States.

“The CPT Category Administrative MAAA code approval is recognition by the leading panel of medical experts in

the United States that the Cxbladder tests are now established diagnostic tests addressing an important unmet

medical need,” said Jackie Walker, CEO of Pacific Edge Diagnostics USA Ltd.

“The multiple peer-reviewed clinical studies and the growing adoption of the tests in the United States were key

factors in the decision by the CPT Editorial Board reviewers.”

CEO of Pacific Edge, David Darling, commented: “This positive reimbursement code award continues to reflect the

growing acceptance of Cxbladder as effective, non-invasive and highly accurate tests for the detection and

improved management of urothelial cancer. Having unique codes in place will facilitate reimbursement for

Cxbladder in the US, minimising barriers for urologists who order Cxbladder tests for their patient care.”

For more information contact:


David Darling

Chief Executive Officer

Pacific Edge Ltd

P: +64 (3) 479 5800


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.


9 March 2018
Company Announcement


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.

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