Pacific Edge Agreement With National Provider Network FedMed Gives 40 Million Americans Access to Cxbladder

Posted on October 16th, 2013

NZX ANNOUNCEMENT: Released 16 October 2013

Dunedin, New Zealand and Hershey, PA

Pacific Edge (NZX:PEB), a cancer diagnostic company leading in the development and commercialisation of molecular diagnostic tests, has signed an agreement with FedMed, a national preferred provider network in the United States, to make Cxbladder available to an additional 40 million Americans.

The agreement with FedMed Inc has been finalised with Pacific Edge’s subsidiary in the USA, Pacific Edge Diagnostics USA (PEDUSA).

The agreement provides FedMed’s contracted insurance carriers, third party administrators, health and welfare funds, and self-insured health plans with access to Cxbladder. More than 40 million Americans have access to FedMed’s National Provider Network of over 550,000 physicians, 4,000 hospitals and 60,000 ancillary care providers nationwide.

Pacific Edge Chief Executive Officer, David Darling, says the agreement is further recognition for Cxbladder and its ability to enable clinicians to detect urothelial carcinomas, including cancers of the bladder, from a small urine sample. Combined with the simple to use Urine Sampling System, the Cxbladder technology makes detection of bladder cancer a more effective proposition for both clinicians and patients alike.

The Chief Executive Officer of PEDUSA Jackie Walker says: “We are enthusiastic about the continued market acceptance of our Cxbladder test for bladder cancer detection.The Cxbladder proposition as a quick, cost effective, non-invasive and highly accurate cancer detection test is particularly appealing to US healthcare professionals, patients, and insurers who can see its positive benefits”.

“This is a big step forward for Cxbladder and further supports our direct marketing efforts to clinicians and cancer patients.” Negotiations are underway with other provider networks and insurers as well as integrated health systems, Medicare and Medicaid.

“Gaining traction in the world’s largest health market is generally acknowledged as a lengthy process for new products and therapies. However, the signing of the FedMed partnership, coming so soon after our CLIA certification, is a sign of significant and rapid progress by Pacific Edge in this market.”

Additionally, Pacific Edge has seen significant commercialisation progress over the last 12 months in New Zealand with the successful completion of clinical validation studies and the signing of its first client District Health Boards.

The commercialisation program for Cxbladder has hit all its milestones on time and within budget in the lead-up to the official launch in the US in July 2013. It has gained recognition from clinicians globally from the publication of the peer reviewed multi-centre international study in the Journal of Urology in September 2012.

PEDUSA’s custom built, commercial laboratory was completed in September 2012 to process Cxbladder samples, was certified earlier this year by CLIA to enable the laboratory to offer Cxbladder as a Laboratory Developed Test (LDT) to clinicians and physicians.

“The building blocks are in place, sales people are active in the market and Pacific Edge remains confident of reaching its target of revenues of $100 million from Cxbladder sales in the USA within five trading years,” David Darling says.

There are approximately 10,500 urologists in the US with an expected annual seven million cases of patients with blood in their urine (haematuria) which will result in approximately one million of those patients receiving urological evaluation to determine if they have bladder cancer. Currently more than $1 billion a year is being spent in the US investigating this haematuria.