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Area Biotech Company Banyan Biomarkers On Cutting Edge

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The founders of Banyan Biomarkers describe the Alachua-based research firm as a “Gator-made company.”

Banyan made news recently when it was awarded a $26.3 million Department of Defense contract to develop a diagnostic blood test for traumatic brain injury, or TBI. The company has been studying “biomarkers,” or proteins in the blood produced by an injured brain.

An estimated 1.4 million people annually suffer a traumatic brain injury in the U.S., resulting in more than 230,000 hospitalizations, 50,000 deaths, and 80,000 to 90,000 people left permanently disabled. Currently, 5.3 million Americans live with TBI-related disabilities, compared with 4 million who are disabled by Alzheimer’s disease.

In the military, it is estimated that up to 20 percent of combat veterans have suffered some degree of traumatic brain injury due to bomb blasts while in Iraq or Afghanistan.

Banyan’s blood test, which looks for unique proteins that spill into the blood stream from damaged brain cells, has put the company on the biotech map. But what really excites Banyan executives Ron Hayes, Kevin Wang and Jackson Streeter are potential products also in the research pipeline at the company’s Center of Innovative Research, or CoIR.

Hayes and Wang left faculty positions at the University of Florida to spin off Banyan in 2002. Banyan’s CoIR promotes basic and applied human disease research that is focused on brain disorders, but it also includes other organ systems such as liver damage. CoIR investigators have landed 16 grants from the National Institutes of Health and the Department of Defense.

Streeter joined the company in February as CEO and chief medical officer, relocating from San Diego.

Hayes says Banyan was founded to address two systemic failures, within universities and “big pharma.”

The universities do a good job at discovery in small laboratories run by dedicated investigators, Hayes explained. Where they fall short is in trying to commercialize their discoveries readily. Large pharmaceutical companies, he said, have learned that it is impossible to manage discovery.

“Now, they go ahead and buy discovery where they can find it,” Hayes explained. “You can’t manage genius, but you can put it in place.”

That was the thinking that led to Banyan and its research institute within the company.

The company’s next big test will come with trials of its biomarker for traumatic brain injury. Brain injury diagnosis is currently done through a clinical exam and expensive imaging studies, primarily CT scans that can involve a radiation risk for the patient.

Banyan’s simple point-of-care blood test can be administered on the battlefield or the site of a roadside crash to detect whether a patient has a brain injury. “When we achieve that, it is a huge breakthrough,” Streeter said. “It will prevent unnecessary CT scans and lead to more rapid diagnosis of patients who urgently need treatment for a brain injury.”

With Department of Defense funding, Banyan’s TBI biomarker will be tested beginning next year on 1,200 patients selected at 30 centers, 10 of them in the United States. Streeter says one center will be the University of Florida, with others will be in Ocala, Tampa, Jacksonville and potentially Tallahassee.

If the U.S. Food and Drug Administration approves the biomarker test, it could be on the market by 2013.

The discovery could be a milestone in brain-injury care, according to Gregory O’Shanick, national medical director for the Brain Injury Association of America.

“We will find people who are under the radar and then treat them appropriately,” he said.

“So many biotech companies are ‘one trick ponies’ that live or die based on one single product,” Wang said. “Very early on, we wanted to diversify what we were working on.”

The firm is complementing its diagnostics development by offering a range of core biomarkers for research applications along with service offerings based on its panel of neurological, psychiatric, neurodegenerative disease, and organ toxicity biomarker assays. Additional analytical services use the firm’s animal models and primary neuronal culture models of neuroinjury or neurotoxicity. Nanoparticle researchers are looking at ways to package drugs for delivery to the nerve cells.

Others are working on stem-cell research, collaborating with colleagues at the Chinese University of Hong Kong, looking at stem cells extracted from adipose (fat) tissue. The company also is creating a neuro-proteomics center that will support the TBI studies and enable researchers to look at other neurodegenerative diseases.

Chronic traumatic encephalopathy, or CTE, has increasingly been identified in boxers and pro football players who have suffered numerous concussions, Wang said.

“How many of our high school and college athletes will be impacted by this in their lifetime?” he asked.

There is no blood test for early diagnosis of Alzheimer’s disease or CTE, just examination of the spinal fluid, which is a very invasive test, Wang said.

“Most companies have a restricted repertoire,” Hayes said. “What separates Banyan as a biotechnology company is the richness of our pipeline.”

Source: Gainsville.com