Breakthrough in fast, disposable DNA testing

Thermal Gradient announced today that it has successfully developed a 30-cycle PCR device that can amplify DNA in just 4.4 minutes, far faster than anything available in the marketplace.

According to Dr. Joel Grover, CEO of Thermal Gradient, the disposable, microfluidic thermal cycling device "demonstrates everything we had hoped for with our first-generation technology, and we are now seeking strategic partners to help develop products based on it."

PCR (polymerase chain reaction) is the most common method of performing DNA tests. It involves amplifying or making a huge number of copies of specific DNA sequences and usually takes an hour or more to carry out.

Thermal Gradient announced last September that it had shown the feasibility of amplifying DNA with its device and has steadily improved its performance since then.

"We are now able to run reactions three times faster than we could just a few months ago," Dr. Grover said, "and we are working on second-generation technology for the Department of Homeland Security. DHS hopes to use the extraordinary speed of our device to help with its mission."

Dr. Grover explained that PCR today is run in specialized instruments that perform just one or a few kinds of tests at a time, and only in batches.

"Until now," he said, "no one has been able to make a PCR instrument that is automated and flexible, like an immunodiagnostic or clinical chemistry instrument, one that allows a clinician to select and run tests on samples brought to the instrument on a random basis. The short cycle time of our technology makes it possible to do that. It brings the concept of lean thinking to the process of DNA testing."

Dr. Grover added that because the device is so easy to use, it has advantages in point-of-care and point-of-use applications.

"A clinician would simply install our chip into a device in which the sample would be pumped through it," he said. "The PCR protocol is built into the chip. It's easy to imagine simple, hand-held testers based on it for use in the emergency room or a doctor's office. We envision running DNA tests in minutes while the patient is being examined for infections like HIV, Hepatitis, methicillin-resistant staphylococcus or the multiple causes of sepsis. It's also easy to envision similar kinds of testers for use in forensics and food and water testing."

The company's first prototype device consists of multiple layers of silicon and other materials and is roughly half the size of a fingernail. It was fabricated at the Infotonics Technology Center in Canandaigua, NY. All testing has been performed at the Functional Genomics Center of the University of Rochester, with the assistance of Prof. Andrew Brooks of Rutgers University. The Trillium Group has backed the company since its inception in 2004.