Clinical Validation of Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis, to support CLIA Waiver

Project Summary Sinusitis is a common illness with an annual economic burden of over $8 billion. Each year, 10.7 million people are diagnosed with acute sinusitis in the U.S. and 80% receive a prescription for antibiotics. However, less than 10% of sinusitis cases are caused by bacteria; sinusitis accounts for more adult antibiotic prescriptions than any other outpatient diagnosis. Patients with routine upper respiratory illnesses, such as sinusitis, often visit primary or urgent care clinics with a predisposition to receive antibiotics without fully appreciating the need or risks. With 1 in 1000 patients suffering serious, often life-threatening, adverse effects due to antibiotics and the looming threat of antibiotic resistance, physicians need better tools to diagnose patients with sinusitis. Often healthcare providers lack point-of-care (POC) diagnostic tools that can reveal the underlying cause of a patient’s illness. They are forced to rely on imprecise methods to make diagnostic decisions or refer patients for complex procedures under a specialist’s care. Currently, there are no products available on the market to diagnose bacterial sinusitis at the point-of- care. ENTvantage Diagnostics has developed the first rapid, point-of-care diagnostic test kit that can identify the three pathogens responsible for bacterial sinusitis. Included in this test kit is a specialized mucus collection device that allows for sampling of the middle meatus, the drainage site of the paranasal sinuses, without the need for an endoscope or specialized training. Building on our prior successes during prototyping and feasibility, we have refined a fully multiplexed assay combined with a simple to use sample collection device to be used at the POC. During this performance period, Entvantage will evaluate the clinical performance of the Sinu-TestTM Bacterial Assay Kit and reader system. The Sinu-TestTM Bacterial Assay Kit will improve patient care by providing physicians with a means to accurately diagnose patients with sinusitis who otherwise would be treated empirically. In addition, this POC test will improve patient safety and reduce direct and indirect costs to the healthcare system by reducing unnecessary antibiotics prescribed for sinusitis. The purpose of this renewel is to expand the clinical performance evaluation to include sufficient native specimens to meet the requirements set by FDA for CLIA-Waiver.