ARC Begins Clinical Trials for First-of-its-Kind Device for Antibiotic Overuse
November 09, 2018
Austin Company Testing First-of-its-Kind Device to Curb Antibiotic Overuse
- ‘In Office’ Tool Aims to Accurately Diagnose Sinus Infections
- Austin Regional Clinic only clinical research site in Austin
October 16, 2018 – Austin, Texas – If you live in Central Texas, commonly referred to as an “allergy capital”, chances are you or a family member have suffered a sinus infection, also known as sinusitis. And chances are, if you have had sinusitis, an antibiotic has been prescribed. Yet, according to public health experts, the vast majority of sinusitis cases are not helped by antibiotics.
This “antibiotic overuse” is associated with the rise of antibiotic resistant bacteria which are making it more difficult to fight illnesses. The Centers for Disease Control (CDC) calls antibiotic resistance as "one of the most urgent threats to the public’s health”.
Preventing unnecessary antibiotic use specifically for sinusitis is one of the issues that ENTvantage Diagnostics Dx is trying to solve. The Austin, Texas-based medical device company has begun clinical trials for their Sinu-TestTM product that aims to accurately diagnose if the sinusitis symptoms are caused by bacteria, which can be resolved with antibiotics, or a virus, in which case, saline spray, hot compresses, and over-the-counter decongestants are often recommended. The simple tool, which fits in the palm of your hand, conveniently and painlessly collects a sample from a patient’s nose and can provide the results quickly, in the same office visit.
“It’s fast, convenient, and, if proven effective, will help physicians know which patients need antibiotics and will keep most patients from receiving antibiotics they don’t need,” said ENTvantage Dx Chief Executive Officer, Joe Skraba.
ENTvantage Dx is currently enrolling patients in research trials to evaluate the effectiveness of Sinu-Test. Austin Regional Clinic (ARC) is the only clinical site location in Central Texas and one of just two in Texas.
Said Dr. Anurekha Chadha, medical director for ARC’s Clinical Research department, “The medical community has long needed more convenient and less costly methods for diagnosing common illnesses like sinusitis. We are excited to offer this clinical trial in Austin. If successful, it could be groundbreaking in how we approach sinusitis treatment.”
Sinusitis strikes 29 million adults in the U.S. While the CDC estimates a bacteria is the cause for only 10 percent of sinusitis cases, antibiotics are often prescribed for 80 percent of infections.
Most sinusitis sufferers visit a primary care provider or an urgent care center for care. “Currently, there is no way to conveniently diagnose a sinus infection — doctors rely on a patient’s symptoms and history. We hope our tool revolutionizes the way this common illness is treated,” explained Skraba.
Sinusitis is inflammation or swelling of the tissue lining the sinuses. Normally, sinuses are filled with air. When they become infected by a virus, the sinus tissue swells, causing congestion and can block normal drainage, which creates an environment for bacteria to grow. Symptoms of sinusitis include “stuffy” nose, cough or congestion, nasal drainage, loss of smell, and facial pain or pressure.
In addition to the sinusitis trial, ARC Clinical Research is actively enrolling for four trials. Ongoing research include: rheumatology, type 2 diabetes and uterine fibroids. For information, visit www.austinregionalclinic.com/services/clinical-research.
About ENTvantage Diagnostics
ENTvantage Diagnostics, an Austin, TX based diagnostic company that provides physicians with point-of-care information on the underlying cause of ear, nose and throat illnesses. Its first product market opportunity exceeds $2 billion the initial targeted markets annually. Use of the FDA Class II kit will improve the accuracy of their diagnosis, reduce the amount of antibiotics prescribed unnecessarily to treat sinusitis, and increase revenue to the clinic using established reimbursement codes. For more information visit www.entvantagedx.com.
About Austin Regional Clinic and ARC Clinical Research
Austin Regional Clinic is a multispecialty medical group committed to providing comprehensive healthcare services throughout Central Texas. Founded by three physicians in 1980, it now provides health care to over 470,000 area residents in 24 locations in 10 cities, including both primary and specialty care. In 2017, it launched ARC Clinical Research, which aims to look at new ways to prevent, detect, or treat diseases that may benefit patients in the Central Texas community and beyond. For more information visit www.austinregionalclinic.com.