01: BioPorto launches The NGAL Test™ for diagnostic use
January 31 2011
Announcement no. 01
BioPorto launches The NGAL Test™ for diagnostic use
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 long-sought 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™ and acute kidney injury
Acute kidney injury affects up to 13 million people a year, of whom about 4 million die. Nevertheless, there has been no real progress in methods of diagnosing kidney injury over the last half century. The NGAL Test™ now provides physicians with the tool they need to diagnose kidney injury much earlier than ever before. Existing methods, e.g. measuring serum creatinine, only indicate kidney failure 24-72 hours after kidney injury has taken place. In contrast, NGAL determination can demonstrate kidney injury within a few hours and thus allow physicians to take measures before the damage progresses to potentially fatal kidney failure. In addition to benefitting the patient, cost-benefit analyses shows that implementation of NGAL testing will contribute to saving hospital expenditure on treating patients with kidney damage.