BreviTest Awarded SBIR Phase II Grant from National Institute on Drug Abuse to Commercialize Device for Rapid Opioid Testing
Houston, TX (October 22, 2019) - BreviTest Technologies has been awarded a $1,500,000 grant from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH) to further the commercialization of its point-of-care analyzer for rapid opioid urine testing. The funds are awarded as a Small Business Innovation Research (SBIR) Phase II grant and will be used to perform design-for-manufacturing activities for BreviTest’s portable analyzer and perform validation of the device using patient urine samples.
The opioid epidemic is an increasing healthcare concern in the U.S., with a staggering 47,600 opioid overdose deaths reported in 2017. The sharp increase in opioid fatalities in recent years has been attributed to the large amount of opioid medications being prescribed for pain management, such as for post-surgical and chronic pain. In response to this crisis, the CDC has established guidelines for prescribing opioids for chronic pain, including a recommendation for physicians to use urine drug testing prior to prescribing opioids, to identify potential drug abuse or diversion.
Pain management physicians who do not have an in-house laboratory must send samples out to a testing laboratory and wait 1 to 3 days for the result. The turnaround time creates a barrier to implementing universal urine drug testing, as the patient must needlessly suffer while awaiting the test results and follow-up visit to the physician.
“Because of the delay in receiving laboratory results, many physicians use urine drug testing sparingly. The BreviTest analyzer will allow any doctor to measure opioid urine levels in-office, which will help them identify individuals who are misusing the drugs,” said BreviTest’s Michael J. Heffernan, Ph.D., principal investigator on the project.
Since the award of the previous SBIR Phase I grant from NIDA, BreviTest has made substantial progress in developing its portable analyzer for performing rapid and quantitative enzyme-linked immunosorbent assays (ELISAs). In the current SBIR Phase II project, the team will further refine the design of the analyzer and disposable cartridge to prepare for manufacturing scale-up and validation of the device with patient samples. This will support an eventual submission of a 510(k) premarket notification to the FDA. The anonymized opioid-positive patient urine samples will be provided by APC Health, a Houston-based diagnostic and toxicology testing laboratory.
“The opioid epidemic has put tremendous pressure on caregivers to manage their prescribing of opioid drugs,” said Rohan Nath, Managing Member of APC Health. “I am enthusiastic about the development of the BreviTest device, as this innovation has the potential to help curb the opioids crisis in our country through the use of quantitative point-of-care testing.”
BreviTest Technologies, LLC is managed by Fannin Innovation Studio (www.fannininnovation.com), an early-stage biomedical commercialization firm that uses a shared management team of experienced entrepreneurs, scientists, and engineers to develop its portfolio technologies.
“Our BreviTest team is excited to receive this support from NIDA to advance our point-of-care diagnostics technology into the clinic,” said Fannin executive chairman Leo Linbeck III. “Putting a convenient, accurate opioid test in the hands of physicians will be an important step in combatting the opioid overdose epidemic facing our country.”
Founded in 2013, BreviTest is an early-stage life sciences company that has developed a biomedical assay platform technology to perform ELISAs in a microfluidic environment. The patent-pending technology has been reduced to practice with a point-of-care device.
About APC Health, LLC
Houston-based APC Health, LLC is a diagnostic laboratory serving physicians and their patients in the Greater Houston area. Our mission is to provide physicians a growing range of high-quality, proven diagnostics testing services while helping accelerate the market introduction of new, innovative technologies that can improve patient care. For more information, visit www.apchealthllc.com.
Houston-based Fannin Innovation Studio is an early-stage life sciences development group focused exclusively on commercializing biotech and medtech technologies. Fannin partners with life science innovators to create startup companies, providing management, funding, and business development. To further bridge the commercialization gap, Fannin’s fellowship and internship programs provide aspiring entrepreneurs with hands-on development experience with its portfolio companies. For more information, visit www.FanninInnovation.com, come by the Studio at 3900 Essex Lane -- Suite 575 in Houston, or email us at firstname.lastname@example.org.
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