NEW YORK (GenomeWeb) – Astute Medical said this week that it has signed an agreement with Shanghai Fosun Long March Medicine Science for distribution of its NephroCheck test for assessing risk of acute kidney injury in China.
The deal also calls for Fosun to provide Astute with $20 million in financing, which the company plans to use for ongoing commercialization of NephroCheck as well as development of additional tests in its pipeline, CEO Christopher Hibberd told GenomeWeb.
He declined to comment on the status of any tests in the company's pipeline. In addition to AKI, Astute has research programs in acute coronary syndromes, abdominal pain, cerebrovascular injury, and sepsis.
Astute is now working with Fosun on preparing Chinese trials for NephroCheck that it will use to gather data for a submission to the Chinese Food and Drug Administration, Hibberd said.
"We are planning those trials right now ... identifying the right centers and making sure that we have clarity with the authorities on what we plan to do," he said.
Astute received US FDA clearance for the test last year and launched US sales through its strategic partner Ortho Clinical Diagnostics. The company received an EU CE mark for the test in 2012 and launched sales that year.
The test is intended for use primarily in critically ill hospital patients. According to Astute, of the more than 5 million such patients in the US annually, around half go on to develop AKI, which is associated with significantly longer hospital stays and readmission rates, as well as increased costs and worse outcomes.
NephroCheck 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. According to the company, it can identify patients who will go on to develop AKI with an accuracy of around 90 percent.
Hibberd said that Astute believes the Chinese market for the test is at least as large as that in the US.
"I would say the problem is at least as large [in China] as in the United States," he said, noting that China has "dramatically" increased the number of intensive care unit beds available in the country in recent years.
"They have a number of well resourced institutions with critical care facilities and similar profiles of patients who develop acute kidney injury," he said.
Astute plans to launch sales of the test in China on its Astute140 Meter point of care device, but, Hibberd noted, the company is working with partners to develop higher-throughput versions of the test.
In January the company signed an agreement with BioMérieux for development of a medium-throughput NephroCheck test to be run on that company's VIDAS immunoassay platforms. In addition, OCD is developing a high-throughput version of the test for use on its automated Vitros testing platform.