Designation highlights Adaptyx Biosciences innovation in continuous molecular monitoring and accelerates the pathway for FDA authorization of novel continuous cortisol monitoring device.
Menlo Park, CA, Sept. 23, 2026 (GLOBE NEWSWIRE) -- Adaptyx Biosciences, a Stanford University spinoff developing a wearable biosensing platform capable of measuring multiple biomarkers continuously and simultaneously, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its continuous cortisol monitoring device, and that the company has been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP).
Adaptyx’s continuous cortisol monitoring device is designed to support diagnosis and management of suspected and active excess cortisol states and low cortisol states. Excess cortisol, known as hypercortisolism, can result from Cushing syndrome and other conditions, while low cortisol or hypocortisolism can be caused by adrenal insufficiency. Breakthrough Device Designation gives Adaptyx expedited FDA review and more frequent, structured interaction with the agency as the continuous cortisol monitor moves through development. Adaptyx's engagement in TAP pairs the company with dedicated FDA review teams for proactive, structured feedback and early access to payers and provider organizations to align regulatory and reimbursement strategy in parallel.
“This designation validates what we’ve long believed: that continuous cortisol data can change how clinicians diagnose and manage adrenal disease,” said Vijit Sabnis, Ph.D., co-founder and CEO of Adaptyx Biosciences. “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.”
“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. Medical and surgical treatments have accelerated, and now it is time for diagnostic and management tools to catch up,” said Daniel Grossman, M.D., Chief Medical and Business Officer, Adaptyx Biosciences. “These adrenal conditions are chronically underdiagnosed and a challenge to manage because patients and clinicians have relied on single-time-point blood draws to characterize a hormone that fluctuates throughout the day. 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. 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.”
Clinical medicine has long relied on laboratory testing to aid clinicians in decision-making. But these tests are most commonly single-time point tests, which can not measure the complex dynamics of the human body, such as hormone rhythms. Continuous monitoring addresses this, but has historically been limited to enzyme-mediated biosensing, which addresses only a small number of molecules, such as glucose and ketone bodies. Adaptyx’s breakthrough technology overcomes these limitations by designing and optimizing molecular switches, engineered strands of DNA that change shape and provide an electrical signal when they bind their target. The Adaptyx platform extends continuous measurement to a far wider range of molecules.
Adaptyx plans to use its accelerated FDA engagement to advance its pivotal clinical program focused on diagnosis and management of cortisol-related disorders, including hypocortisolism seen in Adrenal Insufficiency and hypercortisolism seen in Cushing syndrome, as well as other conditions of hypercortisolism such as Mild Autonomous Cortisol Secretion (MACS), difficult to control type 2 diabetes, and resistant hypertension.
About Adaptyx Biosciences
Adaptyx Biosciences is a Stanford spinout commercializing more than 18 years of continuous molecular biosensing research from the laboratory of H. Tom Soh, Ph.D., a Stanford professor and Chan Zuckerberg Biohub investigator, as well as technology developed by the laboratory of Joseph M. DeSimone, Ph.D., a Stanford professor, recipient of the National Medal of Technology and Innovation, and co-founder of the 3D printing company Carbon.
Adaptyx holds an exclusive license to nine patents from Stanford covering the underlying technology and has filed 18 additional patents since founding. The leadership team includes Chief Executive Officer and Co-founder Vijit Sabnis, Ph.D., Chief Science Officer and Co-founder Alex Yoshikawa, Ph.D., and Chief Medical and Business Officer Daniel Grossman, M.D.
Adaptyx has raised $23 million in seed financing to date. The company's Continuous Molecular Monitoring platform uses programmable, DNA-based molecular switches to read hormones, drugs and pharmaceutical compounds, electrolytes, and other biomarkers continuously in dermal interstitial fluid. The platform's first clinical analyte is cortisol, and its commercial focus is continuous hormone monitoring. Adaptyx is headquartered in Menlo Park, California. For more information, visit adaptyx.bio.
CONTACT: Media Contact: Vijit Sabnis info@adaptyx.bio
