Phase II year
2020
(last award dollars: 2022)
Phase II Amount
$2,488,836
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 patients illness. They are forced to rely on imprecise methods to make diagnostic decisions or refer patients for complex procedures under a specialists 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.
Public Health Relevance Statement: Project Narrative Annually, 10.7 million people are diagnosed with acute sinusitis in the U.S. with less than 10% of these cases being caused by bacteria; yet 80% receive antibiotics, more than any other outpatient diagnosis. With 1 in 1000 patients suffering serious, sometimes life-threatening adverse effects due to antibiotics, physicians need tools to diagnose patients with sinusitis. Entvantage Diagnostics has developed the Sinu-TestTM Bacterial Sinusitis Assay Kit, the first Point of Care (POC) test for rapid diagnosis of bacterial sinusitis that will improve patient care and safety by providing physicians with a means to accurately diagnose patients with sinusitis who otherwise would be treated empirically, as well as reduce direct and indirect costs to the healthcare system by reducing unnecessary antibiotics prescribed for sinusitis.
Project Terms: Accounting; accurate diagnosis; Acute; acute bacterial sinusitis; acute rhinosinusitis; Adult; Adverse effects; Algorithms; Americas; Antibiotic Resistance; antibiotic resistant infections; Antibiotics; Bacteria; base; Bedside Testings; Biological Assay; Caring; Chronic Sinusitis; Clinic; Clinical; Clinical Investigator; Clinical Research; Collection; Communicable Diseases; Complement; Complex; Consult; cost; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Direct Costs; Drainage procedure; Economic Burden; Endoscopes; Endoscopy; Engineering; Etiology; Evaluation; experience; Facial Pain; Facilities and Administrative Costs; Fatigue; Fever; Foundations; Funding; Goals; Guidelines; Health Personnel; Healthcare Systems; improved; Industry; Instruction; Investments; Lead; Life; Logistics; manufacturing scale-up; Medical Device; Methods; Mucous body substance; Multi-site clinical study; Nasal cavity; National Institute of Allergy and Infectious Disease; Nose; novel; Outpatients; pathogen; Patient Care; patient safety; Patients; Performance; performance tests; Phase; Physicians; point of care; point-of-care diagnostics; Positioning Attribute; Predisposition; Primary Health Care; Procedures; Process; prototype; rapid diagnosis; Reader; Reproducibility; Resources; respiratory; Risk; sample collection; Sampling; Scientist; Sensitivity and Specificity; side effect; Sinus; Sinusitis; Site; Societies; Specialist; Specimen; success; Symptoms; System; Testing; Time; tool; Training; urgent care; Veterans; Viral; Visit; waiver
