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Anagnostics Obtains CE-IVD Mark for Sepsis Test, Adds Belgian Distributor

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Austrian array company Anagnostics recently achieved a CE-IVD mark for a test that could help clinicians guide treatment for patients with sepsis. Separately, the firm announced a new distribution partnership in Belgium, further expanding its presence in Europe.

Anagnostics' test, called Hybcell Pathogens DNA PlexA, runs on the firm's Hyborg array platform. Markus Jaquemar, Anagnostics' managing director of sales, marketing, and business development, told BioArray News this week that the test targets 16 gram-positive and gram-negative bacteria, "covering the most significant bacteria encountered."

While most commercially available arrays are printed on slides, Anagnostics prints its Hybcell arrays on cylinders that are processed in sample containers. The newly CE-IVD marked sepsis test pairs the Hybcell's properties with Molzym's SepsiTest sample preparation kit, which is used to extract pathogens from blood samples, followed by amplification of the targeted bacterial genomes, and a compact sequencing step.

According to Anagnostics, turnaround time for the new assay from DNA extraction to result is about three and a half hours. St. Valentin-based Anagnostics licensed the rights to use Bremen, Germany-based Molzym's kit as part of its test earlier this year (BAN 7/10/2012).

In addition to the new sepsis test, privately held Anagnostics also sells a number of panels for use on the Hyborg, such as its Drugs of Abuse Saliva PlexB and Urine PlexA assays have both been CE-IVD marked, and its Drugs of Abuse Urine PlexB and Oncogenes Tissue PlaxA test for KRAS mutations, which are available for research use.

The company said that it plans to launch a multiplexed test for fungi in the next six months, as well as an assay to monitor "10 critical inflammation parameters" by the end of the year. Jaquemar said that the fungi test will identify a series of candida and aspergillus species and that Anagnostics will achieve a CE-IVD mark for it in the first quarter of 2013. He added that the inflammation test is currently available for research use.

Separately, Anagnostics recently signed a distribution agreement with Analis, a Namur, Belgium-based firm, to commercialize its products in Belgium and Luxembourg. The company serves clinical laboratories in the region with life sciences and clinical diagnostics tools, according to its website.

The deal is the latest in a string of distribution pacts for Anagnostics. Over the past year, the company has inked similar agreements with GenXpress Service & Vertriebs to distribute its pharmacogenetics-focused assays in Austria; Ramcon to reach customers in Denmark, Finland, Iceland, Norway, and Sweden; Cell.Eng to represent it in Italy; Invicon to sell its products in Germany; and Biogenetix to represent it in the Romanian market (BAN 7/10/2012).

Jaquemar said that Anagnostics is currently discussing similar partnerships in Germany, Switzerland, the UK, and other European countries. The path to the North American and Asian markets is less certain though.

"We are currently evaluating a possible scenario for accessing the US market, but it is clear that a strong partner in the US would certainly accelerate that process," said Jaquemar. "As far as Asia is concerned, we have no definite plans as of now, apart from India and the Middle East, where we are already screening the market with potential distribution partners," he said.

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