NGAL test registered for diagnostic use in Russia; BioPorto provides status on progress in BRIC coun


BioPorto's Russian distributor, Diakon, has obtained registration approval for the NGAL (neutrophil gelatinase-associated lipocalin) test from the Russian health authorities. The approval covers the use of the NGAL test for the diagnosis of acute kidney injury. The NGAL test is designed for routine diagnostic use on chemistry analysers from manufactures such as Roche, Abbott and Siemens.

Following the CE-marking of the NGAL test in Europe, BioPorto has prioritised the BRIC (Brazil, Russia, India and China) countries, whose markets are expected to continue to grow, particularly due to the general improvement of health services. Through its Chinese partners, BioPorto achieved two registrations in China, two registrations in India (import licenses) and now registration in Russia has been obtained. The application for registration in Brazil is pending, and is expected to be achieved in the first quarter of 2013.

In China, the health authorities' recognition of the test by registering and subsequently determining reimbursement for is crucial for doctors' use of the test. The application is pending and BioPorto expects higher sales when the grant is obtained. The test is also available for in vitro diagnostic use in Canada and South Korea.

This article is tagged to:
Sector: Medical Devices
Geography: Russia, China, India