A Monkeypox PCR Test Is in the Works

The team behind the revolutionary rapid polymerase chain reaction (PCR) test for COVID-19 recently announced they are adapting the platform to detect monkeypox. Developed by Northwestern University spinoff company, Minute Molecular Diagnostics, the initial COVID-19 PCR test received FDA emergency use authorization (EUA) status to expedite introduction to the public in response to the ever-expanding pandemic. With a new foe taking center stage, Northwestern and Minute Molecular are collaborating to develop the swab-based monkeypox test and plan to submit an EUA application to the FDA in early 2023.

Infectious disease specialists at Northwestern University Feinberg School of Medicine will lead the clinical testing and use the Minute Molecular DASH Analyzer to enable non-laboratory personnel to use it. DASH is a compact, portable system that provides easy-to-read results in approximately 15 minutes.

“To help control the spread of this contagious infection, the development of rapid diagnostic testing is essential,” said Northwestern’s David Kelso, co-founder, president, and CEO of Minute Molecular. “DASH provides central laboratory-quality results at the point of care.”

Northwestern’s Sally McFall, co-founder and chief scientific officer of Minute Molecular, continued: “The simplicity of the DASH test adds an important new tool to combat the monkeypox emergency. DASH enables non-laboratory personnel to insert a swab specimen into the test cartridge and load the cartridge into the analyzer. Then an accurate result is provided in 15 minutes.”

The approximately 15-minute wait would result in faster result delivery to patients. Currently, after a patient is tested for monkeypox, physicians send the samples to a central laboratory facility where it’s run in large batches, which takes several hours to provide results.

“DASH is distinguished by its simplicity, speed, and PCR-level accuracy,” said Dr. Chad Achenbach, associate professor of medicine (infectious diseases) and preventive medicine at Feinberg and lead of the DASH clinical evaluation. “The DASH interface walks the user through all the steps making it just as easy to use as a coffee maker. DASH is ideal for point-of-care testing in clinics and immediate care settings.”

Although the DASH platform was initially designed for COVID-19, the technology can be used to detect other viral and bacterial agents, including monkeypox. Additionally, Minute Molecular is currently developing similar tests for the flu, HIV, hepatitis C, several STIs, MRSA, and C. diff, using various sample types, including nasal swab, saliva, and blood. Of note, the PCR testing system can also quantitatively report viral loads of HIV and hepatitis C.