- Development of a Rapid Automated Point-of-Care Test for Mycobacterium tuberculosis Detection from Tongue Swabs and Sputum Specimens on the DASH® Rapid PCR System
- Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH® Rapid PCR System
- A-416 Clinical and Analytical Evaluation of the 15-minute, FDA-Cleared, CLIA-Waived, DASH® SARS-CoV-2 and Flu A/B Test Performed on the Point-of-Care DASH® Rapid PCR System
- Evaluation of the analytical performance of the 15-minute point-of-care DASH™ SARS-CoV-2 RT-qPCR test
DASH Platform
Bringing Laboratory-Quality PCR Testing to the Point of Care
Problem
Traditional PCR testing, the gold standard for pathogen detection, requires centralized laboratory infrastructure, skilled technicians, and processing times that can take hours or even days. During the COVID-19 pandemic, these limitations contributed to diagnostic delays, increasing transmission risk and hindering timely clinical intervention. Although rapid antigen tests offered near-immediate results, they often sacrificed sensitivity and accuracy, particularly in patients with low viral loads. The unmet need was clear: a diagnostic platform capable of delivering PCR-level accuracy with the speed and convenience of a point-of-care test.
Solution
Developed by Nuclein, The DASH® Platform is a compact, sample-to-answer PCR system designed for use in clinics, pharmacies, urgent care centers, and other point-of-care settings. The platform delivers laboratory-quality PCR results in just 15 minutes with only one minute of hands-on time, enabling rapid clinical decision-making without sacrificing accuracy. Its intuitive interface requires minimal training and no calibration, making it easy to implement across a wide range of healthcare environments. With a compact footprint, the system is well suited for space-constrained clinical settings, while its multiplex capabilities allow for the detection of multiple pathogens from a single test cartridge. Built-in Wi-Fi and cloud connectivity streamline reporting and integration with healthcare systems, and room-temperature-stable cartridges eliminate the need for refrigeration, simplifying storage, transportation, and inventory management.
The DASH platform delivers lab-quality PCR accuracy with the speed and simplicity of a home antigen test, providing results before the patient leaves the clinic so treatment decisions can be made immediately and care improved.”
— Sally McFall, PhD
Research Professor, McCormick School of Engineering
Benefits
- Lab Quality Accuracy: Matches PCR sensitivity and specificity, outperforming antigen tests.
- Speed: Enables “test and treat” in a single patient visit.
- Accessibility: CLIA waived, allowing use outside traditional labs.
- Cost Effective: Affordable solution compared to centralized PCR testing.
- Versatility: Supports a wide range of sample types and pathogens.
Technology & Commercialization Status
The DASH® Rapid PCR System is based on molecular diagnostics technology developed by McCormick Professors David Kelso and Sally McFall, whose research in microfluidics and point-of-care testing established the scientific foundation for rapid, near-patient PCR diagnostics. Nuclein launched DASH during the COVID-19 pandemic to address urgent diagnostic needs. The platform’s first FDA-cleared, CLIA-waived assay, the DASH SARS-CoV-2 & Flu A/B Test, enables clinicians to differentiate between COVID-19 and influenza in minutes.
The system was co-developed with design partners including Westberg Innovation, DiMonte Group and Ontogen Medtech, ensuring clinical usability and scalable manufacturability. Today, DASH is commercially available through Nuclein’s distribution network and partners such as Cardinal Health, with plans to expand the test menu to additional viral and bacterial pathogens.
Northwestern Inventors
David M. Kelso, PhD
Clinical Professor of Biomedical Engineering
McCormick School of Engineering
Sally M. McFall, PhD
Research Professor of Biomedical Engineering
McCormick School of Engineering
Links
Website: https://www.nuclein.com/