T2 Biosystems (Cambridge, Massachusetts) is looking to prove an old saying true, that good things really do come in small packages.
With its 8-pound prototype diagnostics unit, the company looks to build small portable devices that can bring the power of magnetic resonance imaging (MRI) and screening into any setting, whether it be ambulatory or the battlefield, in a quicker and more efficient method.
Most recently the device, which has yet to be approved by the FDA or get a proper name, was validated in a study published in Nature Medicine.
The prototype, which is about the length of a sheet of paper, can detect if bacteria or viruses are in a liquid sample. The device isn't bogged down by all the usual testing methods — which include sample preparation, separation of componenets and cell cultures.
Instead the device uses nanoparticles, which are coated with a polymer and have an iron core that is studded with molecules that attach to whatever they are trying to detect. These nanoparticles can be thrown directly into a sample of blood or urine. If the target cell or molecule is present, the particles wind up clustering together as they stick to it. That aggregation can be detected by the portable reader device, using magnetic resonance.
"What we're doing is measuring the magnetic resonance of a water molecule," John McDonough, T2 Biosystems CEO, told Medical Device Daily. "There's no need to prepare the blood or urine; we can actually get a test on a dirty sample. This eliminates time in the lab preparing the sample and cost associated with preparation. Because of the size and simplicity we can move the diagnostics toward the patient."
T2 is actually the signal that occurs when the nanoparticles cluster together hence the name of the company and possible future name of the device.
The device has a small screen and an indicator that can classify what kind of bacteria or virus is in the sample.
What the published study in Nature Medicine found was that an even smaller version of the prototype could be used to get an accurate test.
"This exciting data shows that this T2 technology-based prototype is currently two to three orders of magnitude more sensitive than the standard NMR scanners used in many laboratories today, and the revolutionary potential this technology can bring to bear on the field of clinical diagnostics," said Ralph Weissleder, PhD, author of the paper, co-founder of T2 Biosystems and a professor at Harvard Medical School (Boston).
He added, "This novel technology will ultimately enable immediate, accurate diagnostic testing for nearly any health condition, in nearly any setting."
Specifically, the study demonstrated that a prototype device developed by the investigators at Massachusetts General Hospital (also Boston) and Harvard performed measurements on biological samples, accurately detecting bacteria with high sensitivity, identifying small numbers of cells and analyzing them on a molecular level in real time, while measuring a series of protein biomarkers in parallel.
The results showed that the prototype distinguished between simulated blood samples representing healthy individuals, those with cancer, and those with diabetes, by looking for eight different biomarker molecules and also demonstrated it is sensitive enough to detect just 10 bacteria in a given sample.
McDonough added that this study opens up a whole new realm of possibilities for the device in the future.
"In enough time we're going to have the ability to take this device and shrink this down to the size of the hand," he said. "It's not far-fetched to think that one day down the line something like this could be built into your iPhone."
But before T2 Biosystems can claim its slice of the $35 billion diagnostics sector pie, it first must gain FDA approval. McDonough is hoping that in two years the device will be approved and said that it would be launched immediately after approval.
T2 Biosystems is a private company developing next-generation medical diagnostic products using its proprietary technology, combining nanotechnology and miniaturized magnetic resonance technology to provide rapid, accurate and portable diagnostics.
The company was founded in 2006 and received $5.5 million in Series A funding from Flagship Ventures, Polaris Venture Partners and IDG Ventures.