Philadelphia's Graphene Frontiers is developing a hand-held, point-of-care diagnostic device that can detect heart attack biomarkers from a drop of blood within minutes, thanks to the use of the company's namesake material.
Other companies are trying to make diagnostic devices that use a single drop of blood, to much fanfare and big-name backing. Supported by the Bill & Melinda Gates Foundation, the DNA Medicine Institute took home $525,000 for winning the Nokia Sensing Xchallenge, while the backers of San Diego startup Cue include an early funder of Uber, as well as actor Leonardo DiCaprio and former Obama campaign manager Jim Messina.
But fellow maker of blood drop-based tests Theranos tops the list. Former director of the U.S. Centers for Disease Control and Prevention Dr. William Foege and Riley Bechtel, chairman of engineering and construction conglomerate Bechtel Group, recently joined the company board that also includes former U.S. secretaries of state Henry Kissinger and George Schultz, former Senator Samuel Nunn, former chairman and CEO of Wells Fargo Richard Kovacevich and retired U.S. Marine Corps General James Mattis.
Advantages of this minimalist approach include home-based diagnosis, convenience, speed and minimal strain on the patient. But it takes high technology to pull off reliably and up to the standards of the FDA. The promising approach is far from overcoming the inertia of centralized lab-based testing, though Theranos is offering its diagnostic tests at a growing number of Walgreens' stores. Graphene Frontiers adds a twist to the plot through the use of, well, graphene, a potential material of the future.
|Graphene Frontiers Chief Scientific Officer Bruce Willner|
"Graphene makes an almost ideal sensor-based material," Graphene Frontiers Chief Scientific Officer Bruce Willner told FierceMedicalDevices. "Most critically it is a two-dimensional material. It's very important to get the point across that that doesn't only mean it's very thin. It's not the same as putting a very thin layer of gold or a very thin layer of silicon down."
Very thin layers of gold or silicon are still 3-D materials, but graphene's thickness is the length of an atom, or as thin as can be. "Graphene is an atom-thick layer of carbon atoms, all of which are bound to each other, with no dangling bonds to bind with surfaces above or below it. It's a self-contained two-dimensional material," Willner said.
The 11-person company is funded by an angel investment of $2 million and $1 million in grants from federal government institutions including the National Science Foundation and the Air Force, Willner said.
The planned diagnostic "will be a hand-held reader device and a disposable chip that's specific to the disease," said Graphene Frontiers' vice president of business strategy and scientific research, Victoria Tsai, during the interview. "You would put a drop of the patient sample--it could be blood, saliva, urine--on the chip, insert the chip into the reader, and get the result very quickly, within minutes."
After inserting the chip into the reader device, the user will receive the concentration of biomarkers of interest.
"There is a big need for highly sensitive sensors. Many diseases are defined by low-abundance biomarkers which current technology cannot detect quickly and quantitatively," Tsai said. "So our biosensors' application is best for diseases in which diagnostic biomarkers are present in low concentrations in the physiological system."
In addition to heart attack biomarkers, the device will also test for Lyme disease.
But that, of course, depends upon receiving FDA approval for the device. Graphene Frontiers is aiming to find a strategic partner, such as a large diagnostic company with experience dealing with the FDA, so that it can apply for regulatory approval and also gain expertise in the commercialization and distribution arenas, Tsai said, adding that she hopes to find a partner within the next 6 months.
|A sample custom wafer of graphene manufactured at Graphene Frontiers' Philadelphia headquarters--Courtesy of Graphene Frontiers|
One of the chief challenges involving graphene is manufacturing, Willner said: "Graphene is most commonly made on a copper substrate. It's a good catalyst for making material, but graphene is rarely useful on copper and you really need to put it onto some other material in order to use it, whether it's a silicon wafer or a polymer."
The company has a patent for a method of transferring graphene from copper to other materials that Willner said enables Graphene Frontiers to reuse the copper to make more graphene "again and again" at low cost.
The company is far from the first to see promise in graphene as a material for medical devices and diagnostics. The European Union is betting heavily on the potential material of the future via a €1 billion ($1.3 billion) research fund dubbed the Graphene Flagship. Graphene-based foldable touchable screens are under development, and another Flagship-funded researcher previously told Bloomberg that the material could someday form drug-delivering drones powered by a spinning tail that is similar to a sperm's. And researchers at the University of Wisconsin-Madison have come up with a graphene-based implantable sensor so thin that scientists studying the brain can see through it using a wide range of imaging technologies.
Meanwhile, Willner is looking to expand the graphene-based sensor's reach to include the diagnosis of infectious diseases, autoimmune diseases, and cancer. "Rather than tests drawing vials of blood, we'll test for 20 different biomarkers at once using one drop of blood, with results in minutes rather than days," he said. -- Varun Saxena (email | Twitter)