BioPorto

Regulatory Filings • Mar 11, 2013

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 investor@bioporto.com