ARC Teams with Austin-based ENTvantage Diagnostics Dx for New Clinical Trial
First-of-its-Kind Device to Curb Antibiotic Overuse Aims to Accurately Diagnose Sinus Infections
November 29, 2018
ARC’s newest clinical trial tests a device that could help curb antibiotic overuse, "one of the most urgent threats to the public’s health,” according to the Centers for Disease Control (CDC).
By teaming with Austin-based medical device company, ENTvantage Dx, ARC is conducting clinical trials for Sinu-Test™, a device that tests the presence of bacteria in mucus samples from sinusitis patients. Sinusitis affects 29 million adults in the U.S. and antibiotics are often prescribed for 80 percent of infections; however, the CDC estimates bacteria is the cause for only 10 percent of sinusitis cases.
A recent article in the Austin American-Statesman highlighted the trial, currently underway at Austin Regional Clinic and in 11 other sites in the U.S. and three sites in Australia.
Bacteria or Virus?
Joe Skraba, ENTvantage Dx CEO, expects to do about 1,300 tests in this study and hopes to get FDA approval next fall. Once approved, the tool could be used in a primary care doctor’s office or clinic to quickly determine which sinusitis patients have bacterial infections and need antibiotics and who has a viral infection, best treated with a decongestant or nasal spray.
Dr. Anurekha Chadha, the director of ARC’s Clinical Research, likens Sinu-Test to a rapid flu or strep test. Results with Sinu-Test can be ready in 15 to 30 minutes, compared to the four to seven days required for results from an endoscopy administered in an ear, nose and throat doctor’s office.
“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.”
ARC Clinical Trials
This is one of six clinical trials currently being conducted by ARC to look at new ways to prevent, detect, or treat diseases that may benefit patients in the central Texas region.
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. To participate, call the ARC Clinical Research team at 512-225-5931 or fill out the Clinical Research interest form online.