Prostate cancer is the most common type of cancer found in American men, other than skin cancer, but not all men are being tested. A new test strip under development, similar to urine-based pregnancy tests but with an electronic twist, will make it more convenient for more men to test for the disease.
Gentag (Washington) and MacroArray Technologies (Philadelphia) have teamed up to design a wireless immunoassay incorporating Gentag's cell phone communication technology and MacroArray's urine diagnostic test for prostate cancer.
"It would likely be available at some point over the counter, like pregnancy tests, but because it's a cancer test, the physician should always be involved. It could be sold in pharmacies, but results would be sent directly to physicians," Gentag CEO John Peeters, MD, told Medical Device Daily.
He estimates FDA approval is still two years away.
"This technology will be very competitive with current technology in terms of price. Other tests require a lab; this will be much cheaper," he said.
The American Cancer Society (Atlanta) estimates that there will be about 186,320 new cases of prostate cancer in the U.S. in 2008 and about 28,660 men will die this year. More than 2 million men in the U.S. have survived prostate cancer at some point and are still alive today. The death rate continues to decline as the disease is caught at earlier stages.
MacroArray last year reported the identification of a urine protein called ABCA5 that can serve as a sensitive diagnostic marker for high-grade prostatic intraepithelial neoplasia (PIN), a lesion often the precursor for this disease — sometimes attacking swiftly, but more typically slow growing (MDD, Feb. 15, 2008). This precursor cannot be identified via prostate-specific antigen (PSA).
MacroArray reported that men with high-grade PIN are at the highest risk for developing prostate cancer, with about 50% developing prostate cancer within three years of diagnosis and 80% developing it within eight years.
Current tests for prostate cancer include the PSA blood test, and a digital rectal exam. Not only is the test under development anticipated to be more convenient, Peters said it is a more accurate cancer detector than PSA.
"Sensitivity of the PSA is below 50%," Peters said. "The sensitivity of our test is 80%. Also, the PSA has 70% false positives and ours has 30% false positives."
With the new test, men would place a urine sample on the test strip that incorporates an embedded wireless sensor tag. The antibodies in the strip test will react with the antigens in the urine and the resulting data will be sensed by the embedded electronic tag and communicated to a cell phone or PDA, which then would process the data and transmit the results to the patient's physician.
To date, the Gentag-MacroArray prostate test has been studied in limited trials. The next phase of development is integration into the two platforms.
Peters declined to reveal a potential price point for the test or details of its deal with MacroArray.
Gentag owns intellectual property relating to cell phone-sensor combinations and wireless sensor networks, including U.S. patent Nos. 7,109,859 and 7,148,803.