NEW YORK (GenomeWeb) – Astute Medical said today that it has received US Food and Drug Administration 510(k) clearance for its NephroCheck Test System, a protein biomarker-based test for assessing risk of acute kidney injury.
The company said it plans to launch US sales of the test in coming weeks through its strategic partner Ortho Clinical Diagnostics, the exclusive sales agent for Nephrocheck.
"The availability of biomarkers for AKI risk assessment can play a pivotal role in evolving practice from a 'wait and see' era to a 'let's prevent and treat it domain' Mayo Clinic nephrologist Kianoush Kashani said in a statement. "Clinicians will be able to integrate the test with clinical information to improve decision making, which aligns with the goal of offering better preventive care and earlier action."
According to Astute, AKI is a significant contributor to hospital deaths and increased healthcare costs, often afflicting the sickest patients, including those with sepsis and who have undergone major surgery.
NeproCheck measures the presence of two proteins – insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) – in urine, allowing clinicians to assess in about 20 minutes the risk of a patient developing AKI in the next 12 hours.
San Diego-based Astute received an EU CE mark for the test and launched European sales in 2012.