If all goes well, two years from now the shroud of mystery surrounding head injuries to soldiers, athletes and accident victims will be lifted, as the first ever blood test pinpointing brain damage goes on the market.
The test, discovered by University of Florida researcher Ron Hayes, is being developed by Alachua-based Banyan Biomarkers. Banyan has just begun clinical trials with 2,000 patients at 25 medical centers in the U.S. and Europe, including Shands at UF.
A $28.6 million Defense Department contract is covering the cost of the large clinical trials, which are the last hurdle to FDA approval.
The current clinical trials expand initial trials on several hundred patients. “All of our data indicates that this test will be very useful for the detection of brain injury, even mild concussions,” Streeter says.
With the test, physicians can quickly determine the extent of a brain injury, which helps them determine the best way to treat a patient.
“Our test will save lives,” says Banyan CEO Dr. Jackson Streeter. “If it had been available when actress Natasha Richardson was injured at a ski resort in 2009, it would have saved her life.
“In situations like that, our test should be given. If needed, the helicopter should come out and get you to a place where a neurosurgeon is available to save your life. We’re rendering invisible injuries visible.”
After the test goes on the market, Banyan expects to add 15 to 20 employees at its headquarters in the Progress Corporate Park as it increases production of the material for the test. The company now employs 38 in the Progress Corporate Park and 12 in California.
Banyan’s goal is that a major pharmaceutical company will purchase rights to the blood test.
Although an acquiring company probably would move the jobs associated with the brain-injury test elsewhere, Banyan plans to continue work on blood tests for other disorders and to develop a variety of products.
The company also does testing for other researchers studying biomarkers, which are substances used to detect the presence of a disease, and it’s working on medications to treat traumatic brain injuries.
No medication to treat brain injury is on the market today. Banyan is collaborating with a company that is developing a promising treatment, and Banyan is studying some treatments on its own.
“I can see Banyan being here for decades,” Streeter says “We will just bring up the next thing in our pipeline, and keep on doing that.”
Cutting Cost and Improving Diagnosis
Banyan’s test, which doesn’t have a trade name yet, will cost about $100, one-tenth of the cost of a CT scan, the only diagnostic tool available for traumatic brain injury today, Streeter says.
Banyan’s test is more precise than a CT scan. It measures two proteins that normally are present only in the brain but cross what is known as the blood-brain barrier after a head injury.
“The more severe the injury, the higher the amount of the proteins,” Streeter says. “Even with a mild injury, you can detect a certain amount of the proteins.”
Streeter compares the brain injury blood test to the blood test used to diagnose heart attacks. “If a patient comes into the emergency room with heart symptoms, this test is the gold standard,” he says.
Other than CT and MRI scans, the only current way to assess brain damage is by observing the patient and asking them about their symptoms.
“Patients and athletes often don’t come clean about their symptoms,” Streeter notes. He saw that firsthand when he traveled to Afghanistan last year as part of the company’s work with the Defense Department.
During the month Streeter was in Afghanistan, 1,200 improvised explosive devices were detonated near troops. “The severely injured patients get rapidly triaged and taken care of really well, but everyone else who was affected by a blast needed to come forward on their own. The senior leaders were the last ones to do that.”
Streeter also noted what an NFL football star told him: “I will get taken care of really well, no matter what. If a lineman who is a $300,000- to $400,000-a-year guy reports injuries, he can easily be replaced.”
Banyan’s brain injury test will reduce the overuse of CT scans, which carry with them a cancer risk from radiation exposure. “We can save millions of dollars a year in health-care costs and reduce crowding in emergency rooms,” Streeter says.
Moving from Lab to Marketplace
Hayes headed the Traumatic Brain Injury Center at UF’s McKnight Brain Institute before establishing Banyan in 2002.
Streeter visited Banyan four years ago to enlist the company’s help with his California-based company, PhotoThera, which uses laser therapy to protect the brain during a stroke.
About a year later, Hayes asked Streeter to join Banyan. “I thought there was a good business opportunity, and then I had to convince my wife to move from San Diego to Gainesville,” Streeter says.
The move has worked out well for Streeter and his wife, Maria Angela, and their daughters, Montserrat, 15, and Hannah, 7.
Banyan’s staff in California works on moving the company’s products through federal approvals, and it’s coordinating clinical trials.
Streeter has raised $4 million from investors. “They’re getting access to a pipeline of scientific projects with a huge market potential that are cost-neutral because the research was grant-funded,” Streeter says. “I have to make sure that the investors understand that this is not scientific discovery time and that their money is helping us bring our products to the market.”
Streeter credits UF with creating a good environment for commercializing research under the leadership of Win Phillips, the vice president for research, and David Day, director of the Office of Technology Licensing.
“When I moved here, I knew that the place I was coming to wasn’t the backwoods and that there was a great academic institution that knew how to make the connection between big researchers and the marketplace,” Streeter says.