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| The NephroCheck diagnostic test--Courtesy of Ortho-Clinical Diagnostics |
Ortho-Clinical Diagnostics announced that the NephroCheck diagnostic test for acute kidney injury (AKI) is now available nationwide to hospitals, marking another step forward for the product that put developer Astute Medical among this year's Fierce 15 med tech companies.
And Astute's partnership with Ortho-Clinical, its exclusive sales agent, is set to deepen. In about two years, the NephroCheck will be available on Ortho-Clinical's Vitros line of automated testing systems because the companies believe that as volumes increase, customers will want a more automated solution.
"The availability of a test to identify patients at risk of developing moderate to severe acute kidney injury can allow for the recognition and closer management of these patients," said the Mayo Clinic's Dr. Kianoush Kashani in a statement. "A test designed to achieve high sensitivity, such as the NephroCheck Test, allows for the identification of the majority of patients at risk for developing moderate to severe acute kidney injury."
The likelihood of developing AKI is calculated using the AKIRisk Score, which is based on the concentration of two urinary biomarkers, tissue inhibitor of metalloproteinase 2 and insulin-like growth factor binding protein 7.
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).
Because the condition has few symptoms, it can't be diagnosed without a diagnostic, Astute Medical co-founder and chief scientific officer Paul McPherson previously told FierceMedicalDevices. "The NephroCheck provides this early alarm so they can initiate this supportive and preventative bundle earlier when it will really matter to the patient," he explained, adding that there are no therapeutics to treat AKI, making early detection even more important.
In October, Astute said it is hiring 25 sales reps as it seeks to successfully commercialize the product.
Johnson & Johnson sold Ortho-Clinical to the private equity firm the Carlyle Group for $4 billion-plus earlier this year.
- read the release
Special Report: FierceMedicalDevices' 2014 Fierce 15 - Astute Medical