EANS-News: november Aktiengesellschaft / 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 (www.november.eu) 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, (www.progen.de) 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 (www.multimetrix.com). PROGEN is a member of the
VDGH, a German association of diagnostic manufacturers.

end of announcement euro adhoc
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ots Originaltext: november Aktiengesellschaft
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

Dr. Dirk Zurek

CEO

Tel.: +49 (0) 221 82200 520 10

E-Mail: ir@november.de

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