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Brazil’s leading diagnostic company Labtest has obtained registration approval for BioPorto’s NGAL Test reagent from the Brazilian health authorities. The approval covers the use of an NGAL assay for the diagnosis of acute kidney injury.
With this registration in Brazil, BioPorto has executed the first phase of its strategy for the BRIC markets – achieving regulatory approval to sell the NGAL Test reagent in all the BRIC territories. BioPorto and its partners have already begun market penetration activities in these promising markets. The Brazilian IVD market is developing rapidly and a partnership with a company like Labtest puts BioPorto in a favorable position to launch NGAL.
Labtest was founded in 1971 and has become known for its pioneering attitudes and for scientific innovations since then. Selling more than a million kits of reagents per year, it is the leading local player in the diagnostics market in Brazil. At Labtest, the company looks forward to the launch of several marketing initiatives, including participation in Hospitalar, the largest healthcare fair in Latin America, at which the newly registered NGAL assay is to be promoted.
Registration with the health authorities in each market is necessary in order to market a diagnostic product. Following the CE marking of The NGAL Test™ in Europe, BioPorto prioritizes the BRIC countries (Brazil, Russia, India and China), where spending on diagnostics continues to grow due to the general improvement of health services.
The kidney biomarker NGAL
Every year about 13 million people are struck by acute kidney injury worldwide, of whom about 4 million die. Nevertheless, there has been no real progress in methods of diagnosing kidney injury over the last half century. Existing methods, such as serum creatinine determination, only signal kidney failure 24-72 hours after the injury has taken place. In contrast, NGAL rises to diagnostic levels within a few hours of kidney injury and thus enables the physician to make vital clinical decisions before the damage progresses to potentially fatal renal shutdown. In addition to helping the patient, cost-benefit analyses show that implementing NGAL testing will contribute to reducing hospital costs in the management of kidney injury and its consequences.
For further information, please contact:
Thea Olesen, CEO
Christina Thomsen, Investor Relations
Telephone +45 4529 0000, e-mail firstname.lastname@example.org