|NephroCheck Test System--Courtesy of Astute Medical|
The FDA cleared the first and only diagnostic for acute kidney injury (also called acute renal failure) today, Astute Medical announced. A recent study found that hospitalized patients who got AKI had a 30% mortality rate at one year, twice that of a heart attack.
"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," said Dr. Kianoush Kashani of the Mayo Clinic 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."
The clearance paves the way for sales of the NephroCheck Test System in the U.S., where Ortho-Clinical Diagnostics (recently purchased by private equity company The Carlyle Group) is the exclusive sales agent. The product is already available in the European Union.
The NephroCheck Test System tests urine samples for two biomarkers of AKI: insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2). The 20-minute test assesses the likelihood of developing AKI within the next 12 hours.
Treatments for AKI include intravenous fluids, medications to control potassium and restore blood calcium levels, and dialysis, according to the Mayo Clinic. According to Astute, AKI is associated with more than twice the length of hospital stay, higher readmission rates (9.3% vs. 28.6% for severe cases of the condition) and a greater cost to the healthcare system ($13,800 vs. $49,000 per patient).
Astute obtained the 510(k) clearance via the de novo pathway, for novel devices lacking a "substantially equivalent" predecessor that are of low to moderate risk. The use of that pathway by the FDA affirms that the diagnostic is the first regulated product to assess the likelihood of developing AKI.
- read the release
- here's the study abstract about mortality rates
Special Reports: Med tech M&A gets much, much bigger during the first half - Carlyle Group grabs up Ortho Clinical Diagnostics from J&J | The Top 15 Biotech Venture Investments in H1 2012 - Astute Medical