A Skin Patch That Tracks Inflammation Around the Clock Could Provide Early Warning Signs Before They Turn Deadly

NYU Tandon School of Engineering secured up to $31 million in federal funding from the Advanced Research Projects Agency for Health (ARPA-H) to lead an international team of 14 partner universities and companies – including NYU Langone Health – that will build a painless microneedle skin patch to continuously measure inflammation in the body.

The device, called SENTINEL, aims to give patients and doctors early warning of sepsis, lupus flares and worsening chronic disease before lasting damage is done.

"SENTINEL consists of an extraordinary collection of NYU engineers, NYU Langone physicians and top researchers from other disciplines who share the goal of building a real-world device that will help save patients’ lives,” said Juan de Pablo, NYU's Anne and Joel Ehrenkranz Executive Vice President for Global Science and Technology and Executive Dean of NYU Tandon. “The scale of this award and the process through which it was selected signals that this school is the place where next generation health engineering is built."

Inflammation drives many of medicine's deadliest conditions, but doctors can only check it with occasional blood draws. Sepsis, the body's extreme response to infection, strikes about 1.7 million U.S. adults a year, and at least 350,000 of them die or are discharged to hospice. Worldwide, one in five deaths is linked to sepsis. In lupus, inflammation signals can shift weeks before a flare damages the kidneys and other organs.

"This patch will save lives," said Elisa Riedo – Herman F. Mark Professor of Chemical and Biomolecular Engineering (CBE) at NYU Tandon and Professor of Physics at NYU’s College of Arts and Science – who leads the project. "SENTINEL will provide safe, streamlined tracking of inflammation in the human body and alert people if sepsis is developing. In sepsis, every hour counts: studies of tens of thousands of patients show that each hour of delay in treatment raises the risk of death, and early warning systems have been associated with nearly 20% lower mortality when clinicians act on alerts promptly. The patch could also monitor inflammation related to other conditions, much as continuous glucose monitors have done for people with diabetes. Chronic inflammation is often called the 'silent killer,' and it is linked to cancer, cardiovascular disease, autoimmune disorders, and inflammatory bowel disease.”

The patch, smaller than a fingernail, will pair a sensing microchip with microneedles made of hyaluronic acid, a substance found naturally in skin. The needles sample fluid just beneath the skin, where inflammation biomarkers circulate. The microchip is made of transistors, the tiny switches inside every computer. Each transistor will be coated with a molecule that latches onto one biomarker and changes the transistor's electrical signal. Companion chips will power the patch and send encrypted readings to a phone.

The hardest problem will be coating neighboring transistors on a single chip with different molecules, so one device can measure many biomarkers. Riedo's group developed a heat-based patterning method and custom polymers that do this, and the team will now test it in a wearable device. The goal is a patch that tracks 15 markers at once.

The four-and-a-half-year project ends with the patch's first human trial at NYU Langone Health. A patient sent home after surgery could be flagged at the first sign of sepsis. A person with lupus could begin treatment before a flare takes hold.

"By the time sepsis shows up in a patient's vital signs, the body is often already in trouble," said Professor Anna Nolan, a pulmonary and critical care physician at NYU Langone Health who will oversee the project's preclinical and clinical testing. "Today we order blood tests because we're already worried. A patch that tracks inflammation continuously could alert us earlier, when treatment works best."

Riedo, who pioneered a widely used nanoscale patterning technique, leads the sensor chip work. Mahla Poudineh, NYU Tandon associate professor of CBE, developed the hydrogel microneedle sensing platform the patch uses and leads that part of the project. Jeffrey Hubbell, director of NYU's Institute for Engineering Health and Tandon’s Biomedical Engineering interim chair, brings expertise in immuno-engineering and will assess the patch's safety in the body.

Paola Bardetti, CBE industry assistant professor, leads the project's FDA regulatory strategy, and NYU Tandon postdoctoral researcher Aleksei Emelianov will coat and test the transistor sensors.

Glaucus, the NYU spinout Riedo co-founded, will integrate the sensor chips into the patch and lead commercialization. Because it is built with standard chipmaking methods, the patch could be mass-produced for under $100 each.

The project's 14 funded partners are Boston University; the California Institute of Technology; Columbia University; McMaster University; NYU Langone Health; Politecnico di Milano; Stanford University; the University of California, Berkeley; the University of California, Los Angeles; the University of Connecticut; the University of Massachusetts Amherst; Atomica Corp.; Glaucus Inc.; and SkyWater Technology.

The award, part of ARPA-H's Delphi program, is paid in stages as the team meets aggressive and accelerated research milestones. Delphi is led by ARPA-H Program Manager Leonard Tender, Ph.D. The program aims to develop next-generation personalized biosensors capable of reporting expansive biological data critical for management of chronic conditions.