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Pacific Edge Diagnostics Notified of CMS LCD Coverage for Cxbladder®
[October 12, 2020]

Pacific Edge Diagnostics Notified of CMS LCD Coverage for Cxbladder®

DUNEDIN, New Zealand, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Bladder cancer diagnostics provider, Pacific Edge Diagnostics, has been notified by Novitas1 that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder (0012M and 0013M) for tests performed on or after July 1, 2020 that are medically necessary. This LCD coverage enables national reimbursement for Cxbladder tests performed among the approximately 62 million people who have Medicare coverage with the Centers for Medicare and Medicaid Services (CMS) across the USA.

CEO of Pacific Edge, David Darling, said: “This is a transformational milestone for Pacific Edge and the result of many years of hard work and effort from our teams in the US and NZ. This positive outcome results from the generation of substantial clinical evidence, publication of numerous peer-reviewed clinical and scientific papers demonstrating the compelling clinical utility and superior performance of Cxbladder and the growing commercial use of Cxbladder by physicians in the US. We are excited for the opportunity this coverage provides to the many Medicare patients that are affected by bladder cancer in the United States.”

There are approximately 7 million people who present annually with blood in their urine, and of these, approximately 3.4 million are worked up for bladder cancer giving rise to an annual increase of more than 80,000 new cases2. As the 6th most common cancer in the US, and with bladder cancer having the highest recurrence rate of any cancer, there are more than 820,000 people currently living with bladder cancer who will be required to return to their urologist several times a year for up to 5 years.

Cxbladder is a highly accurate non-invasive, urine-based, molecular diagnostic test for the diagnosis and management of bladder cancer. In the US Cxbladder has been recognized in the NCCN guidelines as an appropriate diagnostic test for the monitoring for recurrence of bladder cancer and, most recently, is now covered for Medicare patients. Cxbladder provides a high performance, non-invasive testing option that may lead to earlier detection, reduced complications, and improved compliance for patients presenting with hematuria, the most common symptom of bladder cancer, and for patients already diagnosed with bladder cancer that are under surveillance for bladder cancer recurrence. For more information about Cxbladder, please visit

<>For more information, contact David Darling, Chief Executive Officer, Pacific Edge Ltd, P: +64 (3) 479 5800

For media assistance and imagery, contact Jackie Ellis, P: +64 27 246 2505 | E:, or
Jeremey Feffer, Life Sci Advisors, P: +1 (212) 915 2568 | E:

1 NOVITAS is the CMS Medicare Administrative Contractor (MAC) for Pacific Edge’s USA commercial reimbursement for CMS patients. MACs regionally manage policy and payment related to reimbursement and act as the fiscal intermediary for Medicare. MACs manage provider claims for payment and establish regional policy guidelines, called Local Coverage Determinations (LCDs).
2 American Cancer Society. Cancer Treatment & Survivorship Facts & Figures 2019-2021. Atlanta: American Cancer Society; 2019.

Pacific Edge Limited (NZX: PEB) is a New Zealand publicly listed, cancer diagnostic company specializing in the discovery and commercialization 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 commercializing 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-center clinical studies.

ABOUT Cxbladder Triage
Cxbladder Triage combines the power of the genomic biomarkers with additional phenotypic and clinical risk factors to accurately identify patients with hematuria 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 hematuria 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
Cxbladder Detect enables the non-invasive detection of bladder and other urinary tract cancers from a small volume of a patient’s 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 and the urothelial carcinoma work-up.

ABOUT Cxbladder Monitor
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.

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