Experimental rapid test could tell sinusitis sufferers if they need antibiotics ... or just patience

Now, researchers from The Ohio State University Wexner Medical Center and Nationwide Children's Hospital have developed a new rapid screening test that could help physicians know exactly what type of sinusitis they are dealing with -- and help get patients the right treatment.

"A quick in-office nose swab, and less than 5 minutes later, physicians will be able to more confidently prescribe antibiotics for the estimated 10 percent of sinusitis sufferers who actually need them, versus the 53 percent that currently get them," said Subinoy Das, MD, an adjunct professor of otolaryngology at Ohio State's College of Medicine, who spent nearly a decade working with a team of researchers to develop the diagnostic. "The use of the test could translate into 18 million fewer people getting antibiotics that they don't need, and a positive step towards addressing the major public health issue of antibiotic overuse."

Investors seem to agree. A presentation given by Das about the science behind the diagnostic caught the attention of two Texas-based entrepreneurs. The executives recently formed a start-up called ENTvantage, with Das as Chief Medical Officer, and are actively seeking funding to help push the screening tool closer to market.

Bacteria behaving badly

Das first became interested in diagnostics as an otolaryngology resident during research to find potential biomarkers of sinusitis in the blood. The project wasn't successful, but it got Das thinking about a more specific target -- bacteria in the nasal passages.

"Nasal bacteria seem like an obvious place to start, but at any given time there are hundreds of different types of bacteria in your nose. Sometimes they do nothing, and sometimes they make you sick. So an effective diagnostic has to tell you that something has changed on a biochemical level to make that bacterium behave more pathogenically."

Research has shown that people with chronic sinusitis often have bacteria in their sinuses that have created biofilms -- communities of bacteria with sticky protective covers that help them evade antibiotics and flourish unchecked. These properties also give biofilms a unique biochemical fingerprint.

Thinking that biofilms could be part of the solution, in 2008, Das received a KL2 trainee award from Ohio State's Center for Clinical and Translational Science(CCTS) to start working with one of the nation's leading bacteriologists, Lauren Bakaletz, PhD.

Bakaletz, who is director of the Center for Microbial Pathogenesis at Nationwide Children's Hospital, had already made several critical discoveries about a type of biofilm-building bacterium called nontypeable Haemophilus influenzae (NTHI), which is believed to be responsible for many upper and lower respiratory illnesses.

Building on her previous NTHI work, Bakaletz and Das started searching for the unique biochemical signature of NTHI's biofilm. In the process, they developed a novel chinchilla model of bacterial sinusitis following a viral infection. After looking at hundreds of proteins secreted by NTHI biofilms, they landed on two candidates: outer membrane protein (OMP) 2 and 5 -- proteins that were predominantly present within biofilms formed by NTHI.

With the biofilm signature in hand, the two scientists then invented a technology that reacts to the presence of NTHI proteins by changing color, much like a rapid strep or pregnancy test. They also started to research the best way to collect nasal mucus in an in-office setting.

The work earned Das the coveted 2013 Edmund Prince Fowler Award, which is the top award for basic science research in the field of Otolaryngology.

"The research is a turning point for the future of respiratory clinical care," says Bakaletz, who is also a professor of Pediatrics and Otolaryngology at Ohio State's College of Medicine. "The platform could not only help dramatically reduce the overuse of antibiotics in sinusitis, but could also be used to identify other types of pathogenic respiratory bacteria so that patients can get the best medicine for the specific type of infection that they have."

Das says the research also helps explain why viral infections appear to promote bacterial infections -- a primary reason physicians will often "preemptively" prescribe antibiotics.

"Viruses don't have great mechanisms for spreading on their own, so they hijack bacteria to help them. Viruses send out signals that quiet the immune system and promote bacterial growth. After a few days, your body senses the bacteria, and you start sniffling and sneezing to help clear the bacteria. But what you are really doing is just spreading the virus," said Das. "Eighty to ninety percent of the time these symptoms will subside without any antibiotic needed, but some doctors make the mistake of trying to prevent an infection that isn't likely to develop anyway."

Testing moves forward

With the new start-up fueling the next phase of discovery, Das hopes that there will be a sinus test available to primary care physicians within the next few years.

An accomplished sinus surgeon, Das is working with his nurses and staff to engineer and test hundreds of nasal swab collection devices to make sure that they are simple and don't require the expertise of an otolaryngologist.

"This is a great testament to the power of translational research and the promise of team science," says Das. "We took bench findings about the behavior of respiratory tract bacteria and transformed that into a way to improve patient care for millions. It's been an amazing journey so far, and we're really just beginning."