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Scientists at Claros developed proprietary injection molding technologies that permit the hard-plastic cartridges to be made very quickly, in about 15 seconds, and for about 10 cents apiece. “Injection molding is used to make lots of consumer products, like pens, but we can manufacture them to micron-sized resolution,” says Samuel Sia, one of Claros’s cofounders and a bioengineer at Columbia University. “They cost just a few cents, and we can make hundreds of thousands per year–not many people can do that.”

Claros is currently running clinical trials to compare its device to standard PSA testing methods in order to garner regulatory approval. If approved, it could make a prostate-cancer patient’s visit to the doctor’s office much more productive. According to Stephen Zappala, a urologist at the Lahey Clinic in Andover, MA, who is working with Claros on the clinical trials, “the Claros technology will dramatically increase the efficiency of the urologist’s practice and alleviate patient anxiety associated with waiting for a laboratory result.”

Vincent Linder, a cofounder and chief technology officer, says Claros expect results from the trial in the next few months. The company hopes to launch the device in Europe later this year and in the United States in 2011. Similar technology could be used to create screening panels for women’s health or cardiac health, though Linder declined to discuss specific plans. He also declined to give an estimate of the system’s price.

In addition to the PSA monitoring device, which will be marketed in the U.S and Europe, Sia is developing a second version of the system to screen for infectious diseases in poor countries. While it uses the same core technology, this version has a battery-powered reader about the size of an iPhone and is designed to detect HIV, syphilis, and hepatitis. The device is currently being tested in health-care centers in Rwanda that treat pregnant women. “If you catch the diseases in mothers, you can prevent transmission to newborn, increasing clinical impact,” says Sia. After a series of successful field trials, Sia is now trying to find funding to move the device through the regulatory process in Africa.

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Credit: Claros Diagnostics

Tagged: Biomedicine, Business, cancer, diagnostics, microfluidics, cancer diagnostics, prostate cancer, PSA

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