Bladder cancer, which afflicts more than 400,000 people globally each year, has a 98% survival rate if caught in the earliest stages. Initial testing and survivors must undergo repeated cystoscopies, an uncomfortable test, to diagnose and then check for disease recurrence, which is fairly common.

Pacific Edge Biotechnology (Dunedin, New Zealand) has developed a rapid, urine test based on assaying RNA or proteins using multiple biomarkers with the potential to replace at least some of those cystoscopies.

"It's a very informative test and has great utility," CEO David Darling told Diagnostics & Imaging Week. "It's designed to replace the cytology used as an adjunct to cystoscopy, which is the current gold standard. It's a test used to triage a patient and then following on to determine if that patient has a superficial or invasive cancer."

Pacific Edge was recently issued a Singaporean patent for the test which enables the early detection of bladder cancer from a relatively small volume of urine — just 50 milliliters. Darling said he anticipates patents from other countries to be issued over the next 12 to 24 months.

"The idea is to minimize use of cystoscopes," Darling said. "A patient often will receive a cystoscopy along with diagnosis. Then, European standard procedure is six follow-ups in the first year and then four per year thereafter. In the U.S., there are typically four follow-ups with cystoscopies and then two for the next four years. So that's a total of 12 in the U.S. Those are all extremely invasive and rely on general anesthesia and it's extremely expensive."

Darling said the test won't entirely replace the need for cystoscopy. "It's an important test, but urologists have 85% of cases that test negative and then need to follow up with a new more accurate test that's not invasive and is more cost effective," he said. "A lot of patients don't want the invasiveness and general anesthetic. We expect to see some behavioral changes with this test. Urologists may reduce the number of follow-up tests."

While cystoscopy is the gold standard test, it presents challenges for patient compliance along with the fact that it's relatively poor in efforts to actually assess tumors, Darling said.

"Bladder cancer has the highest total medical costs of all cancers driven by two things: a strong requirement for monitoring following detection and the cost of overall detection technology," he said. "There is a very high recurrence rate: 78% of early stage tumors recur and, of those, 30% come back as late stage tumor. It's a very persistent disease."

Pacific Edge is currently conducting a 1,000-patient clinical trial – with sites in New Zealand and the Soviet Union – that is expected to be completed within a few months.

Darling said the FDA has indicated that an extra cohort is needed for approval in the U.S.

"We're currently talking to investigators in U.S. to put it together and then we will follow through with a PMA," he said. "We've been talking to the FDA for a year and they are very happy with our trial design, but we need to add a cohort of American people. We've yet to design that but it will probably be 300 people."

Pacific Edge intends to first offer the test – to be named uRNA – to Australasian urologists through its Dunedin-based lab following completion of clinical trials later this year. Following that, commercialization will proceed in Singapore, Europe and the U.S. Darling said that Pacific Edge anticipates partnering in several of these locations for lab resources.

The company is forecasting in excess of $100 million in eventual revenues from the bladder cancer test.

Bladder cancer isn't the only target though for Pacific Edge, which is also developing colorectal and gastric cancer tests. The colorectal cancer prognostic test is nearing completion of commercial development and the company has licensed that technology to an as-yet-undisclosed German diagnostics firm. For gastric cancer, a prototype is currently undergoing validation rounds.

Pacific Edge isn't the only company developing a rapid bladder cancer test:

Predictive Biosciences (Lexington, Massachusetts) is developing a test that makes use of a very traditional biomarker, but with a different way of looking at it: negative predictive value. It was designed this way because doctors want to be able to assure patients that they don't have cancer.

Earlier this year, Polymedco (Cortlandt Manor, New York) launched the BTA stat test for the early detection of recurrent bladder cancer. It employs monoclonal antibodies to detect the presence of bladder tumor associated antigen in urine.