Stanford University
A prototype of the handheld ammonia blood detector and associated test strips, developed in collaboration with researchers at Stanford.
Fort Worth-based Elbit Systems of America and its medical instruments division KMC Systems on Wednesday announced a new partnership with startup Aza Technology Inc. to provide a rapid blood ammonia detector.
Aza Technology has developed a Rapid Ammonia Monitoring Device (AMD) designed to detect elevated levels of ammonia, or hyperammonemia, which is critical to prevent irreversible neurological damage, coma, and death. Hyperammonemia can strike at any age and timely diagnosis is limited by the current process and testing technology.
“Our partnership with Aza is another way KMC and Elbit Systems of America are helping to change the landscape of healthcare and drive disruptive technologies in the life sciences space,” said Derek Kane, vice president and general manager of KMC, based in Merrimack, New Hampshire. “KMC is focused on patient forward technology and this exciting partnership will help to bring new technology to market that directly impacts patient care and overall patient quality of life.”
The AMD has been granted “Breakthrough Device” designation from the Food and Drug Administration for point-of-care measurement of ammonia for use in pediatric patients, including newborns as an aid in the diagnosis of inborn errors of metabolism. The device can be lifesaving, officials say, as it aims to dramatically decrease blood ammonia processing times from hours to minutes.
Elbit Systems is a leading provider of high-performance products, system solutions, and support services focusing on the defense, homeland security, law enforcement, commercial aviation, and medical instrumentation markets.
“Between hospital and/or clinic visits, parents and caregivers are challenged to know ammonia levels and when their level would require immediate attention or action,” said Kathy Stagni, executive director of the Organic Acidemia Association. “The availability of a rapid point-of-care ammonia device, such as the AMD, with the capability of monitoring blood ammonia, will be a game-changer for the patient and the caregivers.”
The AMD was developed in collaboration with Stanford University and Stanford Hospital. KMC will support Aza Technology in seeking FDA approval for the AMD for use in both adult and pediatric patients, as well as manufacturing of the device and its consumables.
“Development of an accurate point-of-care ammonia meter has the potential to improve our care of patients with urea cycle disorders and organic acidemias,” said Jerry Vockley, chief of medical genetics and director for rare disease therapy at Children’s Hospital of Pittsburgh.
Read more about the AMD here.