FDA gives breakthrough status to continuous cortisol monitoring device

An experimental device designed to continuously measure cortisol and help diagnose and manage cortisol-related disorders, including Cushing’s disease, received breakthrough device designation from the U.S. Food and Drug Administration (FDA).

The designation is intended for medical devices that may provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases or conditions. It gives developers benefits such as more frequent communication with the FDA and prioritized review when they seek marketing authorization.

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“This designation validates what we’ve long believed: that continuous cortisol data can change how clinicians diagnose and manage [cortisol-related disease],” Vijit Sabnis, PhD, co-founder and CEO of Adaptyx Biosciences, the device’s developer, said in a company press release. “We’re grateful for the FDA’s engagement and are moving as quickly as possible to bring the continuous cortisol monitor to patients who currently have no way to see or understand the truly dynamic rhythms of their cortisol.”

Adaptyx has also entered the agency’s Total Product Life Cycle Advisory Program (TAP), which gives selected medical-device developers proactive, structured feedback during development and regulatory review. TAP can also help companies identify strategic options to streamline the path to patient access.

Cortisol is a hormone made by the adrenal glands above the kidneys that helps regulate many functions in the body. Its levels naturally rise and fall throughout the day, so a single test may not show the full picture of how cortisol changes over time.

Continuously measuring cortisol could help doctors diagnose and manage disorders involving abnormally low cortisol (hypocortisolism) or abnormally high cortisol (hypercortisolism), including Cushing disease. Cushing’s is caused by a tumor in the brain’s pituitary gland that produces too much adrenocorticotropic hormone (ACTH), which triggers the adrenal glands to make excess cortisol.

“Patients with suspected and known cortisol-related disorders, and the clinicians who diagnose and manage them, have not seen a meaningful change in diagnostic technology in many years,” said Daniel Grossman, MD, chief medical and business officer of Adaptyx. “Medical and surgical treatments have accelerated, and now it is time for diagnostic and management tools to catch up.”

Wearable patch designed for continuous cortisol monitoring

Adaptyx’s device is a minimally invasive wearable patch designed to measure multiple biomarkers, including cortisol, continuously over time rather than through single tests taken at one point in time.

The company’s technology uses engineered strands of DNA, called molecular switches, which change shape when they bind to a specific target. This change produces a measurable signal that the device can detect. Adaptyx says its technology could eventually allow continuous monitoring of “a far wider range of molecules.”

“Continuous cortisol monitoring will unlock data that we have never seen before, giving us insights into the human body that we likely could not have imagined,” Grossman said. “The FDA’s breakthrough device designation gives us a faster, more collaborative path to validate the continuous cortisol monitor’s clinical utility and get it in front of the endocrinologists, cardiologists, primary care providers, and patients who need it most.”