Biomarker for AKI Responds Before Other Status Markers

A novel biomarker for diagnosing acute kidney injury (AKI) responds earlier than other renal status markers such as serum creatinine, and shows a proportionate response to injury.

Using only a few drops of plasma or urine the new, rapid NGAL test gives results in just 10 minutes and thus addresses the widespread demand for urgent determination of kidney damage. The test provides a new way to identify patients at risk of developing potentially severe acute kidney injury (AKI) - 24-72 hours before the problem would otherwise be detected.

The NGAL test is designed to run on open channels of chemistry analyzers from various manufacturers, effectively giving most laboratories a convenient and easy way to establish kidney damage. NGAL levels rise rapidly after renal injury and have been used in a variety of clinical situations including intensive care, emergency medicine, renal transplantation, and procedures involving the use of intravenous (I/V) contrast media and other nephrotoxic agents.

BioPorto Diagnostics (Gentofte, Denmark) is now launching the CE-marked NGAL test for diagnostic use in Europe. This means that the company is starting to sell the test to European hospitals, where the physicians will utilize the tool for combating the harmful effects of acute kidney injury.

In November 2010, BioPorto prelaunched the NGAL test for research use, and since then the test has been successfully tested in selected hospitals in Europe, the United States, and Southeast Asia.

"With the CE-marking, we are now starting to sell the test in the EU, but the CE-marking is also an important step towards the world market," said BioPorto CEO Thea Olesen." She added, "In several other key markets such as Canada and India, local approval depends on the CE-marking of The NGAL Test."

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BioPorto Diagnostics