SFC Fluidics (Fayetteville, Arkansas) says it has received a $5 million contract from U.S. Army under the Congressionally Directed Medical Research Program to develop a handheld device for rapid diagnosis of traumatic brain injury (TBI). The device is scheduled to begin clinical trials for FDA approval in the summer of 2013, the company said.

"When there are concussive injuries or other brain trauma the brain produces certain proteins which get into the blood stream and those proteins can be related to the type and severity of the brain injury," Calvin Goforth, president of SFC Fluidics, told Medical Device Daily. "So from the quantitative concentrations . . . of the blood proteins you can make diagnosis of traumatic injuries."

Gorforth said that quantitative is the key word for this type of diagnostic device because it is important to know how much of the protein is present.

According to the company, more than 1.5 million Americans suffer head injuries each year, and TBI has become a signature injury for U.S. troops serving in the wars in Iraq and Afghanistan.

"With a suspected brain injury, every second counts," said Dr. Chris Evans, VP of SFC Fluidics. "We are developing a first-of-its-kind lab on a chip' as well as associated handheld instrumentation to revolutionize the way military and civilian medics diagnose and treat traumatic brain injury."

Using only a pinprick sample of blood similar to a blood glucose test for diabetes, the device is designed to conduct rapid, detailed blood analysis within a single sealed, disposable chip. Quantitative levels of specific biomarkers released by the brain when injured will be displayed on an easy-to-read screen, along with an indicator alerting the operator to the degree of injury – none, mild, moderate or severe, the company said.

Goforth said that ultimately the device would be used in the field – both on the battlefield for triage decisions and during sporting events, such as football games, to determine if an injured player needs to be sent to the hospital or not. However, he added, it may be a two-step process with the first step being to get the device into the laboratory environment first.

"It's easier to develop a device that is in the laboratory because the constraints are fewer [compared to the environmental challenges of using the test in the field]," Goforth said.

SFC Fluidics won the $5 million contract through a competitive process. Goforth said the U.S. Army Medical Research Acquisition Activity office in Fort Detrick, Maryland released a request for proposals which attracted "many hundreds of proposals." Only about 3% of those proposals were selected, including SFC Fluidics', he said.

"Obviously for a field deployable device size and weight and automation are all key, that's where SFC Fluidics' strengths are; we have unique technologies that allow us to do things on [a smaller scale]," Goforth said. "That's why we won the award and that's where our real strengths are."

According to the company the device can be used by first responders without any specific training or medical expertise, and the information will assist caregivers in quickly choosing the proper course of action for the patient in combat situations, at the scene of an accident, in an emergency room or at a sporting event. The device and chip also will provide real-time information about the effectiveness of intervention strategies with successful treatments resulting in a return of biomarker indicators to normal levels, SFC Fluidics noted.

SFC Fluidics is a privately-held company in the emerging market for microfluidic devices.

Amanda Pedersen; 229-471-4212