02/02/2011

BioPorto Diagnostics A/S

The NGAL Test™ launched for diagnostic use

The NGAL Test™ CE
BioPorto has CE-marked and is now launching The NGAL Test™
for diagnostic use in Europe. This means that BioPorto is starting to sell the test to European hospitals, where the first physicians are waiting to take advantage of this longsought tool in combating the harmful effects of acute kidney injury.

In November 2010, BioPorto pre-launched The NGAL Test™ for research use, and since then the test has been successfully tested in selected hospitals in Europe, the USA 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," says CEO Thea Olesen, and continues, "In several other key markets such as Canada and India, local approval depends on the CE-marking of The NGAL Test™.” Thus it will shortly be possible to buy BioPorto’s The NGAL Test™ for diagnostic use in approximately 40 countries. The next step in the launch process is the registration of the test for diagnostic use in other important markets, including the USA, where approval must be obtained from the FDA (Food and Drug Administration).

The NGAL Test™ CE-IVD - a new rapid NGAL assay for clinical chemistry platforms.

Using only a few drops of plasma or urine The NGAL Test™ gives results in just 10 minutes and thus addresses the widespread demand for urgent NGAL determination.

The NGAL Test™ is designed to run on open channels of chemistry analyzers from numerous manufactures effectively giving most laboratories a convenient and easy way to establish NGAL
measurements.

For more information about The NGAL Test™ please visit the product page on our websites www.bioporto.com or www.ngal.com.

What is NGAL?

NGAL is a novel biomarker for diagnosing acute kidney injury (AKI). The key advantage of NGAL is that it responds earlier than other renal status markers like serum creatinine and shows a proportionate response to injury. NGAL therefore 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.

*For in vitro diagnostic use in the European Union only. Available for research use only in countries outside the European Union.