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May 1, 2008

3 Min Read
Researchers Seek Partners for Bladder Cancer Detection Test

R&D DIGEST

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From left to right, Perry Halushka, MD, PhD, Dennis Watson, PhD, and Omar Moussa, PhD, have discovered a cell receptor that appears in the urine of people with bladder cancer.

Researchers at the Medical University of South Carolina (MUSC; Charleston) have discovered a cell receptor that has been shown to accurately identify bladder cancer. Now they're looking for a device company that can translate this information into a diagnostic test, most likely a rapid urine test, for early and noninvasive detection of the disease.

The technology is designed to be similar to the concept of a pregnancy test, in which a patient quickly receives results from a urine sample. The dipstick-type device should be inexpensive enough to be used at home or in a doctor's office, without the need to send samples to a lab.

“The current cost for a cytoscan is around $600, and the researchers are hoping to keep this test under $100,” says Ryan Fiorini, PhD, licensing and technology analyst at the MUSC Foundation for Research Development.

MUSC researchers discovered a cell receptor that appears in the urine of people with bladder cancer. After taking a number of urine samples from patients who were both positive and negative for the disease, their test produced accuracy approaching 100%. Its sensitivity is approximately 93%.

A product hasn't been developed yet. The researchers achieved their results using an enzyme-linked immunosorbent assay (ELISA) test to demonstrate the marker's accuracy in detecting cancer in the bladder. The assay is a common method used in research labs to detect antigens.

“Right now they have a marker that they know shows up in urine,” says Fiorini. “It only shows up in cancer cells, and it's an early detection for cancer.”

Most current tests for bladder cancer involve scoping the area. That procedure is invasive, can be painful, and has a high rate of infection, says Fiorini. A biopsy of the bladder can be taken, but that's not a desirable method either.

A rapid diagnostic test would be most helpful to patients with recurring bladder cancer, a disease that returns at a rate of 50–80% within five years. “Right now there's no good way to test these patients,” says Fiorini. A dipstick test would enable patients to use it on their own and could become part of the trend of using more medical products at home.

“Imagine going home with 12 little sticks that you keep in the refrigerator, and on the first of every month, you take a urine sample,” says Fiorini. “If the stick turns the right color, you go into your doctor, [who] starts looking to see if you have recurrence of that cancer.”

This type of test could also have potential use for gastro-urological applications. Fiorini says the researchers are also hoping to look at renal and testicular cancers.

The MUSC Foundation for Research Development is looking to licensing the technology to a company that has the know-how and resources to move the product into the market. “Our biggest goal is to move a product out that will save lives and improve human health,” says Fiorini.

Copyright ©2008 Medical Device & Diagnostic Industry

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