Allergy, cold and flu season is on the way. Imagine if you could actually know what's causing that sinus infection with a quick test in your doctor's office.
Austin-based ENTvantage Dx has created Sinu-Test, which uses a special collection device to take some mucus from the middle sinus passage. That sample is then prepared and placed on a special tray that detects the three most common bacteria that cause sinus infections. Think of it like a pregnancy test, but in two parts: one is the collection swab that goes in your nose, and the second is the tray that delivers that line or lack of line.
Sinu-Test is going through testing right now locally at Austin Regional Clinic and at 12 other sites in the U.S., including Baylor Scott & White Medical Center in Waco, and four sites in Australia, to take advantage of the opposite seasons the Southern Hemisphere experiences.
The study trials compare the Sinu-Test and a swab test in people with sinus infection symptoms as well as in people who are healthy.
ENTvantage Dx CEO Joe Skraba expects to do about 1,300 tests in this study, which will wrap up by the end of the year or beginning of next year. He hopes to get FDA approval next fall.
Skraba says this test is inspired by the overuse of antibiotics to treat a sinus infection. He and others estimate only about 10 percent of sinus infections are actually caused by bacteria. Some studies put it at even less than that.
Skraba wanted to create a tool that could be used in a primary care doctor's office or clinic to help doctors know when antibiotics are necessary and when they can inform their patients that even though they want antibiotics, those drugs are not going to help their symptoms.
Dr. Anurekha Chadha, the director of Austin Regional Clinic's Clinical Research, who is overseeing the study in Austin, likens Sinu-Test to a rapid flu or strep test. The test results take about 15 to 30 minutes. Endoscopy, typically done in the ear, nose and throat doctor's office after sinus infections don't clear up or can't be explained, typically takes four to seven days to get results.
ARC has done 51 Sinu-Test and swab tests there as of early November; 10 were control tests on healthy people and 41 were on people with the symptoms of a sinus infection, Chadha says. She cannot talk about any results — plus, it's really early in this process.
"It will be interesting to see how much we can see and if it is as accurate as the scope," she says.
ARC is contacting patients who come to their specialists or primary care doctors with symptoms of a sinus infection to ask them to enroll in the study. They have to be 18 or older.
Kimone Aarons, who also works at ARC, participated in the study when she had all the symptoms of a sinus infection. "I started getting the sore throat, the runny nose, the congestion, watery eyes, just feeling like you're wanting to get the flu, but you don't have the fever," she says.
She was told she had a sinus infection and given a 10-day course of antibiotics. Then, days later she learned that the sample taken by scope was negative for bacteria. She was not given the results of the Sinu-Test because of the testing rules. "I had a viral sinus infection, so the prescription that they prescribed did not work," she says. It cleared up on its own days later, and Aarons now knows to use things like Allegra and nasal spray to clear the congestion rather than antibiotics.
The test, which takes about three seconds, wasn't particularly painful, just uncomfortable, and she did have a nosebleed afterward, which is one of the side effects.
Skraba has experienced the test himself. He was the model used in the training video. "I had that thing put into me 100 times," he says. "No CEO was injured in the making of this video."
The hope is that doctors will soon have a quick way to know if antibiotics are appropriate. Less antibiotic use will hopefully mean less antibiotic-resistant bacteria. "Unfortunately, antibiotics aren't benign drugs," he says. He points to not only the antibiotic resistance but also the side effects that some people experience.
If the Sinu-Test passes the FDA and gets used in doctors' offices and clinics, Skraba says they will be able to use existing insurance reimbursement codes that would charge about $55 for the test, which is less expensive than some of the antibiotics.
"I love anything that advances medicine," Chadha says.