Northwestern spinout looks to adapt COVID platform for monkeypox tests

A startup spun out of Northwestern University during the COVID-19 pandemic is working to pivot the rapid, portable diagnostic system it developed for the coronavirus toward tests for the spreading monkeypox outbreak.  

Minute Molecular Diagnostics received an emergency authorization from the FDA this past March for its swab-based PCR test for COVID-19. The compact DASH system, developed in part by researchers at Northwestern University’s Feinberg School of Medicine, aims to deliver results within 15 minutes.

But going forward, the company said it hopes the device will serve as a platform for a range of infectious disease tests including for the monkeypox virus, which has logged more than 25,800 cases in the U.S. since it was first detected in the country in May, according to data from the Centers for Disease Control and Prevention.

Currently, clinicians must mail monkeypox samples to centralized testing laboratories. Last month, the FDA granted its first and so far only emergency authorization to Quest Diagnostics' clinical monkeypox test, which will be processed at labs in California and Virginia.

Minute Molecular—which previously received funding from the National Institutes of Health to expand the reach of its tabletop COVID testing machine—hopes to deliver monkeypox results at the point-of-care, including at sexually transmitted infection clinics, urgent care centers, emergency rooms and doctors' offices.

“The DASH interface walks the user through all the steps making it just as easy to use as a coffee maker,” said Chad Achenbach, M.D., an associate professor of infectious diseases at Feinberg and head of the cereal-box-sized device’s clinical evaluation. 

Samples are collected using a swab, which can then be fed into the analyzer’s test cartridge by non-laboratory personnel. According to the company, the team has a working prototype of the monkeypox test and plans to submit an emergency authorization application to the FDA early next year.

Minute Molecular is also developing similar tests for the flu, HIV, hepatitis C, STIs, MRSA and C. diff infections using samples of nasal swabs, saliva and blood.