Dascena, Inc., a machine learning diagnostic algorithm company that is targeting early disease intervention to improve patient care outcomes, today announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for Previse, the company’s algorithm designed to predict acute kidney injury (AKI) more than a full day before patients meet the clinical criteria for diagnosis. This is the first Breakthrough Device Designation of a cloud-based machine learning algorithm developed for the early detection of AKI.

“Acute kidney injury commonly affects hospitalized individuals, and if not caught early, can result in dangerous outcomes for patients,” said Ritankar Das, chief executive officer of Dascena. “Our machine learning algorithm is able to analyze patient vital sign data and determine whether a patient is at risk of developing acute kidney injury. With this technology, we believe we’ll be able to provide physicians with ample time to intervene and prevent long-term kidney injury in their patients.”

A major challenge in the treatment of AKI is that the clinical criteria for recognition are markers of established kidney damage or impaired function. By predicting whether a patient is likely to succumb to AKI before symptoms present, treatment outcomes could be improved. In validation studies, Previse demonstrated higher sensitivity and predictive value than a clinician’s assessment that relied on clinical criteria, and Previse only utilized patient data that were already routinely collected. In a 2018 paper published in the Canadian Journal of Kidney Health and Disease, Dascena reported that Previse predicted AKI 48 hours before onset with 84% percent accuracy and a diagnostic odds ratio of 5.8.

The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.