Minute Molecular Diagnostics

Minute Molecular Diagnostics (M2Dx) is a spin-off from Northwestern University's Center for Innovation in Global Health Technologies (CIGHT), founded in 2017 by Dr. David Kelso and Dr. Sally McFall. The company is commercializing a point-of-care molecular diagnostics system that provides highly accurate, lab-quality Polymerase Chain Reaction (PCR) test results in approximately 15 minutes.

The company's core product is the DASH (Diagnostic Analyzer for Specific Hybridization) system. It consists of a compact, countertop analyzer—roughly the size of a cereal box—and single-use cartridges. This setup is designed for use by non-laboratory personnel in various point-of-care settings, such as clinics, schools, and workplaces. The process involves a user placing a nasal swab into the cartridge, which is then inserted into the DASH analyzer. The instrument fully automates the complex steps of PCR testing, including viral lysis, RNA purification using magnetic particles, and amplification, delivering a clear positive or negative result on its touchscreen.

M2Dx's first major application for the DASH system was a rapid test for SARS-CoV-2. In March 2022, the company received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its DASH SARS-CoV-2/S Test. The development and manufacturing scale-up were significantly accelerated by a $21.3 million contract from the National Institutes of Health (NIH) RADx initiative. The business model appears to involve the sale of the DASH analyzer and recurring revenue from the single-use test cartridges. The company serves healthcare providers and other organizations that operate under a CLIA Certificate, enabling testing in a wide range of patient care environments. Beyond COVID-19, the DASH platform is designed to be adaptable for detecting other infectious agents, with tests for influenza, HIV, and various sexually transmitted infections in development.

Keywords: point-of-care diagnostics, rapid PCR testing, molecular diagnostics, DASH analyzer, infectious disease testing, COVID-19 test, CLIA-waived, diagnostic instruments, portable PCR, single-use cartridge, nasal swab test, RNA purification, viral load testing, in vitro diagnostics, immunoassay, diagnostic analyzer, SARS-CoV-2 detection, emergency use authorization, medical diagnostics, biomedical engineering