DUNEDIN, New Zealand and HERSHEY, Pa., Oct. 16, 2013 /PRNewswire/ -- 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 said, "This 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."
CEO of PEDUSA Jackie Walker said, "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 said.
There are approximately 10,500 urologists in the US with an expected annual seven million cases of patients with blood in their urine (hematuria) 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 hematuria.
Cxbladder is a proprietary, accurate molecular diagnostic test that enables the non-invasive detection of bladder cancer from a small volume of urine. It provides general practitioners and urologists with a quick, cost effective and accurate measure of the presence of the cancer, and provides urologists with the opportunity to reduce their reliance on the need for invasive tests such as cystoscopy. The recently published, Journal of Urology in September 2012, multi-centre international clinical study recruited 485 patients from Australia and New Zealand.
Results show that Cxbladder out-performed all of the benchmark technologies in the clinical trial and detected nearly all of the tumours of concern to a urologist; At a performance of 82% sensitivity and 85% specificity the test sees 100% of T1, 100% of T2, 100% of T3, 100% of Tis and 100% of upper urinary tract cancers as well as greater than 95% of high grade tumours.
ABOUT PACIFIC EDGE
Pacific Edge Limited (NZX: PEB) is a New Zealand based cancer diagnostic company specialising in the discovery and commercialisation of diagnostic and prognostic technology for the early detection and monitoring of cancer.
Products in development and in clinical trials are accurate and simple to use genomic and proteomic tools for the earlier detection, improved characterisation and better management of gastric, bladder, colorectal cancers and melanoma. The company has recently completed and released its first product for the detection of bladder cancer, Cxbladder, and is actively marketing the product to urologists in New Zealand, Australia and soon to be Spain and the US. For more info, visit http://www.pacificedge.co.nz
ABOUT PACIFIC EDGE DIAGNOSTICS
Pacific Edge takes its exciting cancer detection tests to market through its wholly owned subsidiaries, Pacific Edge Diagnostics NZ Ltd and Pacific Edge Diagnostics USA Ltd, and selected commercial partners in Australia and Spain, Healthscope and Oryzon respectively.
SOURCE Pacific Edge