A first-of-its-kind laboratory test to gauge severe acute kidney injury has been approved for marketing by the Food and Drug Administration.
Developed by San Diego’s Astute Medical, the NephroCheck test is meant to be used in critically ill, hospitalized patients. It can gauge whether a patient pool that generally consists of diabetics, the elderly and those with high blood pressure are at risk of developing moderate to severe forms of acute kidney injury in the 12 hours following the test.
The FDA approval comes right on the heels of a big fundraise for Astute Medical – it brought in about $20 million in July. The well-capitalized company has raised many millions – it brought in $40.2 million in a Series C round in 2012, for example.
Astute Medical identifies protein biomarkers present in blood and urine as the basis of its diagnostic tests. In addition to acute kidney injury, it is developing tests for acute coronary syndromes, abdominal pain, cerebrovascular injury and – quite notably – sepsis.
Acute kidney injury can cause fluid to build up in the body, chest pain, muscle weakness and permanent kidney damage. Current tests can only determine whether a patient has acute kidney injury; a predictive test could help head off serious and permanent kidney damage, or even death, the FDA said. The urine-based NephroCheck test can detect the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2), and provide a feedback score within 20 minutes.
“Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications,” Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, said in a statement. “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.”
The diagnostic test went through a de novo premarket review pathway, which is available to low- to moderate-risk medical devices that stand unique from legally marketed devices. It required two clinical studies among more than 500 critically ill patients, and found that the NephroCheck was up to 92 percent effective. It did, however, give false positives in about half the patients that didn’t have acute kidney injury, the FDA said.
