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New Tests for Diagnosis of Borreliosis approved for use as CE IVD Products

Additional CE certified tests from PROGEN / Multimetrix for a two-step diagnostic of Lyme Borreliosis are approved for laboratory diagnosis

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New Products

Subtitle: Additional CE certified tests from PROGEN / Multimetrix for a two-step diagnostic of Lyme Borreliosis are approved for laboratory diagnosis

Köln, Heidelber, Regensburg, Germany (euro adhoc) - PROGEN Biotechnik / Multimetrix, a 100% subsidiary of november AG, are supplementing their multiplex product line and offer now new additional CE marked tests for the laboratory diagnosis of Lyme borreliosis. The requirements for the diagnosis of Lyme borreliosis established by the National Reference Centre for Lyme borreliosis stipulate a two-step diagnostic procedure. Now the PROGEN/Multimetrix Luminex-based tests can implement these requirements. In addition to our confirmation assays (Borrelia IgM and IgG) new Borrelia Screening IgG and IgM Tests are now available for the first step of the diagnostic procedure. These tests allow for an automated, quantitative and sensitive detection of specific IgM and IgG antibodies in human samples. Also, in cases of suspected Lyme neuroborreliosis the Borrelia IgG and IgM Test as well as the Screening IgG Test are applicable for the detection of specific antibodies in cerebrospinal fluid. The PROGEN / Multimetrix multiplex tests for the laboratory diagnosis of Lyme borreliosis are a cost-effective alternative to conventional tests and offer an improved diagnostic reliability for both levels of the diagnostic procedure.

Borreliosis: Lyme borreliosis is the most common tick-borne infectious disease in the Northern hemisphere. In most European endemic regions, 20-40% of the tick vector Ixodes ricinus carry at least one of the three known pathogenic bacteria species Borrelia afzelii, Borrelia garinii, and the most common pathogen, Borrelia burgdorferi sensu stricto. Clinical symptoms and diagnosis of Lyme borreliosis is a multi-systemic disease with initial manifestations limited to characteristic ring-shaped skin lesions (erythema migrans), which can progress to systemic infection. The course of disease is divided into 3 stages (I-III). The clinical symptoms of Lyme disease are heterogeneous and depend on the tropism of the infectious agent. Preferential targets of the pathogen are connective tissue of skin and joints, and the nervous system. A correlation between individual Borrelia species and defined clinical symptoms has been observed. In serum IgM antibodies are usually not detectable until week 3 after infection.

Companies: november AG ( is an investment and holding company, listed in the prime standard of the regulated market of the German stock exchange (Deutsche Börse), with special focus on medical technology, biotechnology and environmental technologies and a 100% shareholder of the PROGEN Biotechnik GmbH. PROGEN Biotechnik GmbH, located in Heidelberg, Germany, ( is EN ISO 13485:2007 certified and a manufacturer of in vitro diagnostics (Borreliosis, Hanta-Virus, FSME) and research products (antibodies, polypeptides, AAV, hyperphage) as well as specialist for the manufacturing of multiplex assays in bead-technology used for the Luminex® platform. The company is main shareholder of Multimetrix GmbH based in Regensburg, Germany ( PROGEN is a member of the VDGH, a German association of diagnostic manufacturers.

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ots Originaltext: november Aktiengesellschaft
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Further inquiry note:
Dr. Dirk Zurek
Tel.: +49 (0) 221 82200 520 10

Branche: Biotechnology
ISIN:      DE000A0Z24E9
WKN:        A0Z24E
Index:    CDAX, Prime All Share, Technology All Share
Börsen:  Frankfurt / regulated dealing/prime standard
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