PEB
16/10/2013 10:20
GENERAL
REL: 1020 HRS Pacific Edge Limited
GENERAL: PEB: PE Agreement with National Provider Network FedMed
15 October 2013
Pacific Edge Agreement With National Provider Network FedMed Gives 40 Million
Americans Access to Cxbladder
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 (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.
For more information contact:
David Darling
Chief Executive Officer
Pacific Edge Ltd
P: +64 (3) 479 5800
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.
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.
www.pacificedgedx.com
ABOUT Cxbladder
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.
www.cxbladder.com
End CA:00242437 For:PEB Type:GENERAL Time:2013-10-16 10:20:28
