Minute Molecular Diagnostics has developed the DASH™ Rapid PCR System, a point-of-care platform designed to deliver sample-to-answer PCR results in just 15 minutes. This system is characterized by its simplicity and affordability, making it suitable for use in CLIA-waived environments. The DASH™ system boasts a limit of detection (LOD) of 150 copies per milliliter and is capable of processing a wide range of sample types with minimal hands-on time—only one minute is required for setup. Its compact design and user-friendly interface make it as easy to operate as a coffee maker, ensuring accessibility for various healthcare settings.

Clinical trial data highlights the effectiveness of the DASH™ system, demonstrating a sensitivity of 96% and specificity of 98%, with an overall agreement of 98% when compared to the Cepheid GeneXpert. The system has shown to be accurate and efficient in real-life clinical scenarios, with concordant results for the majority of tests conducted. While the DASH™ Rapid PCR System has not yet received FDA clearance or approval, it has been authorized for emergency use by the FDA, indicating its potential for rapid diagnostics beyond SARS-CoV-2, pending further regulatory approvals.

United States

Nuclein, LLC was founded in 2017 by experienced biotechnology entrepreneurs Alan Blake and Dr. Richard Crockett. The company's mission is to create a hand-held, disposable, all-in-one, self-test for infectious disease testing, which delivers battery-powered, sample-to-answer results within one hour, without the need to mail in a sample.

The company is headquartered in Austin, Texas.

Minute Molecular Diagnostics

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