MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
Pacific’s bladder cancer test
may trim invasive cystoscopies
By LYNN YOFFEE
Medical Device Daily Staff Writer
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 Medical Device Daily. “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 Russia – that is
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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 Dunedinbased
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
(MDD, May 20, 2009). 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 (MDD, Feb. 9, 2009).
(This story originally appeared in the June 1, 2009 edition
of Medical Device Daily.)
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