Portable Point-of-Care (POC) Device to Monitor Blood Ammonia in Liver Disease Patients

Increased blood ammonia levels are a common sign of chronic and acute liver diseases and lead to hepatic encephalopathy (HE), which is a serious neurologic condition caused when toxins, including ammonia, that are normally cleared by the liver accumulate in the blood, eventually affecting the brain. Elevated ammonia concentration in the serum and central nervous system (hyperammonemia) is the mainstay for the pathogenesis and treatment of HE. Now, a portable point-of-care (POC) device for blood ammonia monitoring could help meet these challenges.

Versantis AG (Zurich, Switzerland) is developing a prototype POC device named TS-01 based on the polymersome-based ammonia quantification method. TS-01 is a unique point-of-care diagnostic device for at-home measurement of ammonia in blood, the primary cause of HE. The TS-01 assay exclusively licensed by Versantis is based on transmembrane pH-gradient polymersomes that encapsulate a pH-sensitive ratiometric fluorophore. By measuring this fluorescence signal, the ammonia concentration in the sample can be determined. TS-01 has been shown to be accurate across a wider physiological and pathological ammonia concentration range than today’s existing instrumentation and is negligibly impacted by endogenous interferences.

“There is a great unmet medical need for an accurate and user-friendly device to monitor the levels of ammonia in patients with liver disease,” said Dr. Vincent Forster, CSO and co-Founder of Versantis. “Hyperammonemia and its associated neurological manifestations, such as hepatic encephalopathy, affects 30-45% of cirrhotic patients and can lead to coma and death. We believe using a novel portable point-of-care device will allow daily monitoring of ammonia, thereby significantly reducing hospitalizations and fatal outcomes for patients, while also saving time, effort, and expense of health care professionals, supporting caregivers, and family members.”

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