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."

Hanover/Jena (Germany), October 7, 2009 — Analytik Jena AG is launching its newly developed rapid test for detecting the influenza virus H1N1 in time for the start of BIOTECHNICA 2009. The Thuringia-based company, an innovative supplier in the area of complete bioanalytical systems, can thus immediately commence marketing activities, initially for research purposes. The new test is a molecular-genetic rapid test for the direct identification of pathogens. The rapid test was validated both for Analytik Jena’s rapid cycler and the standard cycler of Biometra GmbH, the Goettingen-based company that was acquired in full in May, and is therefore available to a large group of users without the need for any additional investment.

"Based on our Speedcycler technology, the procedure makes it possible to detect an H1N1 infection in less than two hours," Klaus Berka, CEO of Analytik Jena, explained today at the leading biotechnology trade fair in Hanover. "The fact that no expensive equipment systems are required, as for example with real-time PCR procedures, represents a further significant competitive advantage."

The test system maps the entire process chain, from isolation of the viral RNA through to detection of an H1N1 virus infection. The underlying procedure, known as Rapid Amplification Hybridisation (RAH) technology, combines extremely rapid pathogen amplification with simple and sensitive detection on a test strip.

Analytik Jena AG is currently working at great speed in close cooperation with scientific partners to obtain approval of the test for medical applications. A particular benefit of the test is that in the future it will also be integrated into the Mobilab platform, which is also to be introduced as a world first at this year’s BIOTECHNICA. "This means it will soon be possible to use the testing system in places where large numbers of people congregate, such as airports," Berka continued.

Jena, October 6, 2009 — Analytik Jena AG will be appearing at BIOTECHNICA 2009, the leading international trade show for biotechnology, for the first time together with CyBio AG and Biometra GmbH, companies it acquired this year in the field of "bio solutions." With the two companies, Analytik Jena is greatly expanding its product portfolio and emphasizing its status as a full-range supplier of both reagents and instruments in the molecular diagnostics and pharmaceutical market.

As a special highlight of this year's BIOTECHNICA in Hanover, Analytik Jena is starting a sales initiative with a mobile detection system and introducing to the market its mobile laboratory MobiLab, which was developed based on its own patents.

With the new product MobiLab, several established laboratory technologies are for the first time combined very efficiently in a flexible system:

• easy to operate isolation of DNA or RNA, which enables efficient processing of the most varied test matrices and test volumes;
  
• an innovative amplification or hybridization reaction (PCR) based on the quick rapid-cycle technology of Analytik Jena; and
  
• detection of target nucleic acid on a test stripe.

The verification procedure takes place in an innovative cartridge system in the form of a homogeneous assay. In the process, the amplification or hybridisation reaction and the final detection take place in a cartridge, eliminating the need for pipetting steps. The cartridge is discarded after the result is received. Contaminations are thereby excluded. The MobiLab has been designed in such a way that in the future even "non-specialists" will be able to perform molecular diagnostics with it. In doing so, Analytik Jena is tapping into an entirely new customer group. In addition, the MobiLab enables quick pathogen detection in battery operation independent of the presence of a molecular biology laboratory.
In the future, the MobiLab may also be used apart from in laboratories for quick diagnosis — e.g. by veterinarians, police, customs, airports, fire departments, railroad stations or also in production operations to safeguard the product processing chain (e.g. from pig to sausage).

"Analytik Jena AG stands for innovation and closeness to the market. Diverse explosive issues in the area of biotechnology, such as swine flu or testing of ticks as pathogenic agents are included in our research and development activities," said Klaus Berka, CEO of Analytik Jena AG. "Fast and secure diagnosis is particularly important in precisely these topics."

As recently as June, the company from Jena won the Innovation Prize for Central Germany for a detection system for the fast and accurate identification of bacteria and viruses contained in the saliva of ticks. "With this quick system, the result is already available within 1.5 hours — and with savings of up to 70 percent," Berka further explained.

Under the motto "Turning ideas into value", BIOTECHNICA 2009 invites you to come to Hanover from 6 to 8 October for Europe's most important biotechnology industry meeting. For three days, national and international specialists among the exhibitors and the visitors, top quality speakers and investors will lecture, discuss and provide information on innovations, the latest research findings and market opportunities.

Press fotos

Through systematic comparison of 19 DNA extraction protocols applied to only 2 mg of infected leaf tissue and testing 15 different DNA polymerases, the author could successfully amplify a mitochondrial DNA region (cox2; ,620 bp) from herbarium specimens well over a hundred years old. The author concludes that DNA extraction and the choice of DNA polymerase are crucial factors for successful PCR amplification from small samples of historic herbarium specimens. Therefore a combination of suitable DNA extraction protocols and DNA polymerases, only a fraction of the preserved plant material commonly used is necessary for successful PCR amplification.

In this field the innuPREP Plant DNA Kit convices regarding the yield and reliability and was recommended by the author due to this points.

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