US-based Astute Medical has received marketing approval from the US Food and Drug Administration (FDA) for its NephroCheck test, a first-of-its-kind laboratory test to gauge severe acute kidney injury (AKI).
AKI can cause fluid to build up in the body and result in chest pain, muscle weakness and permanent kidney damage.
NephroCheck can gauge whether patients who meet certain factors such as advanced age, diabetes and high blood pressure are at risk of developing moderate to severe forms of AKI in the 12 hours following the test.
Existing tests can only determine whether a patient has AKI, while the new test, if it determines a patient is likely to develop this disease, can prompt closer monitoring and help prevent permanent kidney damage or death.
The kidneys remove waste and extra water from the body and when they don't work properly, waste can gather leading to serious health problems.
AKI is a sudden decline in kidney function after an injury to the kidney caused by a co-existing disease, infection or other condition.
The urine-based NephroCheck test detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) and provides a feedback score within 20 minutes.
The score is based on the amount of the proteins present that correlates to the patient's risk of developing AKI within 12 hours of the test being performed.
Currently, there are no other tests on the market which are FDA-approved or cleared to evaluate the risk of developing AKI in at-risk patients.
FDA Center for Devices and Radiological Health director of the Office of In-Vitro Diagnostics and Radiological Health Alberto Gutierrez said: "Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications.
"The NephroCheck provides health care providers with a quick, validated method of assessing a patient's AKI risk status, which may inform patient management decisions."
NephroCheck test was evaluated in two clinical trials involving more than 500 critically ill people at 23 hospitals.
The new test accurately predicted 92% of acute kidney injury cases in one study and 76% in the other, and it also incorrectly gave a positive result in about half of people without acute kidney injury.