Nutromics Earns FDA Breakthrough Nod for Wearable Vancomycin Monitor

Nutromics, a company building a wearable “lab-on-a-patch” for continuous molecular monitoring, has earned breakthrough device status from the U.S. Food and Drug Administration (FDA) for its first product in development.

The Melbourne, Australia-based company’s first product is a patch in development for vancomycin therapeutic drug monitoring. About 2.9 million U.S. patients receive vancomycin annually to treat serious infections, including sepsis. In 2020, guidelines recommended area-under-the-curve dosing over trough monitoring.

The FDA designated Nutromics’ Vancomycin TDM Patch as a breakthrough device with potential to improve clinical outcomes, citing workflow and accessibility gains and its ability to deliver actionable results and enable faster dosing adjustments than the current standard of care.

Vancomycin is the first of several planned sensors using the company’s DNA-based sensing platform. Its DNA-based sensors, integrated with minimally invasive microneedles, are engineered to sense multiple proteins, drugs, metabolites, and hormones in real time.

Nutromics published first-in-human data on its molecular monitoring platform in Nature Biotechnology in February. Following ICU studies in Australia, the company is preparing U.S. trials and targeting a 2027 launch, pending regulatory authorization.

Future targets include multi-analyte sensors for diagnosing and managing sepsis and cardiovascular disease.

Comments from Nutromics exec and clinicians

Peter Vranes, co-founder and CEO: “Our team is thrilled that the FDA has recognized our patch as a breakthrough technology and has committed to work closely with us on our pivotal study design and submission.”

George Chiampas, emergency medicine physician at Northwestern Hospital: “Vancomycin dosing for individualized patients is incredibly challenging to get right. Access to real-time, continuous data about drug concentrations would meaningfully and positively impact our ability to make dosing decisions.”