US Laboratory complete– regulatory approval process underway
US Laboratory complete– regulatory approval
Cancer diagnostic company Pacific Edge Limited has completed its US$3.7 million laboratory in the United States on-schedule and within budget and is now preparing for registration under the Clinical Laboratory Improvement Amendments (CLIA) regulations.
The purpose-built laboratory in Hershey, Pennsylvania is expected to complete regulatory approval and be fully operational in March 2013 to offer Pacific Edge’s bladder cancer diagnostic test, Cxbladder®, as a Laboratory Developed Test (LDT) to clinicians throughout the United States. The laboratory, with a capacity of 260,000 tests a year, will be operated by a wholly owned subsidiary of the company, Pacific Edge Diagnostics USA Limited (PEDUSA).
Pacific Edge Chief Executive Officer David Darling says “the demanding timetable to launch this business is being met and the focus of the US team led by Jackie Walker is now on completion of the regulatory approvals, sales force deployment and marketing roll-out.”
“There is a growing awareness amongst bladder cancer patients and their clinicians of Cxbladder®, its ease of use, non-invasiveness and its ability to effectively detect bladder tumours.
This awareness has been further advanced by publication in the September 2012 edition of the US Journal of Urology of the peer reviewed paper on clinical tests of Cxbladder®.”
““The United States is the world’s largest healthcare market. This coupled with the 17,000 urologists practising there makes the US the most important market for Pacific Edge and our cancer detection and management products. In the US over one million people annually present to their medical specialist with haematuria (blood in the urine) this gives rise to a total cost in excess of US$ 1 billion to identify patients with bladder cancer, so there is a major opportunity to provide a better and more cost effective solution. Integrating Cxbladder® into the clinical pathway offers an effective detection tool to complement existing clinical work-up; relieves patients from some of the invasive testing and monitoring regimes and gives health insurers a lower overall cost opportunity.”
“Jackie Walker has considerable experience in the commercialisation of medical devices in the United States and is putting together an experienced team to launch Cxbladder® to the medical community.”
PEDUSA’s Pennsylvania location is close to leading medical research and hospital facilities, cancer institutes and from a logistics perspective, a national courier hub which will be important for the rapid delivery of test samples to the laboratory for initial testing. Pacific Edge has a fully funded budget to provide for the staffing and operations of PEDUSA.
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 commercial 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. Pacific Edge completed a $19 million capital raising in September 2011 to fund the launch of Cxbladder® into the US.
Cxbladder® is a non-invasive gene test that enables the early 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 completed multi-centre international clinical study recruited 485 patients from Australia and New Zealand.
Results show that Cxbladder® outperforms all of the benchmark technologies in the trial and detected nearly all of the tumours of concern to a urologist; greater than 95% of all late stage and high grade tumours.
Globally, bladder cancer has the 9th highest incidence and the 4th highest incidence for men. One of the early symptoms of bladder cancer is the presence of blood in the urine, haematuria. People with haematuria often present to their general practitioner before being referred on to a urologist.
There are a number of ‘at risk’ occupations that have shown a much higher incidence of bladder cancer. Fire fighters and fire control officers have shown in a US study to have a 2x incidence of bladder cancer over non fire fighters. Smoking is a significant contributing factor (over 50% in males and 33% in females, approximately 1 of every 2 new incidences of bladder cancer is linked to smoking). Exposure to certain industrial chemicals or carcinogens increases risks for some occupations e.g. hairdressers, painters, printers, fire fighters and metal workers, chemical engineers. Finally, incidence increases with age so the older you are, the greater the potential for bladder cancer.
Bladder cancer has a very high recurrence rate of
approximately 70% with 30% of these recurring as later stage
tumours. This is a higher recurrence than for skin cancer!
However, bladder cancers are highly treatable, especially if
detected in the early stages. If diagnosed early there is a
much higher probability of survival for early stage tumours
relative to later stage tumours. This makes timely and
regular surveillance and monitoring of this cancer a key
element of the clinical process and of the individual’s