# Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis

> **NIH NIH R44** · ENTVANTAGE DX · 2020 · $762,667

## Abstract

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.

## Key facts

- **NIH application ID:** 9910481
- **Project number:** 1R44AI150203-01
- **Recipient organization:** ENTVANTAGE DX
- **Principal Investigator:** Oriana E. Hawkins
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $762,667
- **Award type:** 1
- **Project period:** 2020-02-01 → 2021-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9910481

## Citation

> US National Institutes of Health, RePORTER application 9910481, Sinu-Test, A Multiplexed Device for Rapid Diagnosis of Acute Bacterial Sinusitis (1R44AI150203-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9910481. Licensed CC0.

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