Analytik Jena Obtains Full Approval for H1N1 Test

Jena, December 4, 2009 — Analytik Jena AG`s molecular-genetic rapid test for direct identification of the H1N1 pathogen has been approved with immediate effect for in-vitro diagnostics. The company launched this test in October, initially for research purposes. Since then, several thousand clinical tests have been successfully performed in order to detect this influenza virus under laboratory conditions.

"This approval means that Analytik Jena can now launch two further important tests onto the market for molecular diagnostics and medical use" commented Klaus Berka, Chairman of the Executive Board of Analytik Jena AG. "Our strategy of combining hardware with molecular-diagnostic applications was first successfully implemented across the group following the integration of the new subsidiaries."

The RapidStripe H1N1 Assay KF combines isolation of viral nucleic acids on the KingFisher Flex purification machine with amplification and detection. Using the RapidStripe H1N1 Detection Assay, the user can carry out amplification and detection regardless of the nucleic acid isolation. Both test systems were developed for both Analytik Jena’s rapid cycler as well as the standard cycler produced by Göttingen-based Biometra GmbH, which was 100% acquired in May. Depending on the automated system used, the test provides a result within 2 to 4 hours.

The innovative procedure forming the basis of the two tests, that was developed within the Group and is known as the Rapid-Amplification-Hybridization (RAH) technology, combines amplification of the target nucleic acids with a specific hybridization reaction. The reactions take place in a reaction vessel, the simple visual detection or identification takes place on a test stripe.

"Analytik Jena is well and truly on the road to becoming a systems provider for molecular diagnostics", stated Berka. "We will put great effort in future into developing new products in the area of pathogenic detection — for example in the field of food safety or the investigation of ticks. In the mid-term, we will also increasingly focus on molecular tumor diagnostics in which we develop products for the detection of point mutations in ocogenes as the basis of therapeutic decision-making."