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Anagnostics Inks Biomarker Deal with Virogates; Plans New Inflammation Test

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NEW YORK (GenomeWeb) – Austrian molecular diagnostics company Anagnostics recently announced a partnership with Virogates, a Danish firm that sells assays for measuring immune activation and inflammation levels in patients.

Under the terms of the deal, St. Valentin-based Anagnostics has obtained a license to Virogates' soluble urokinase plasminogen activating receptor, or suPAR, protein biomarker, which is at the heart of Virogates' suPARnostic enzyme-linked immunosorbent assay products.

Anagnostics CEO Christoph Reschreiter told GenomeWeb that Anagnostics aims to include the marker in a new version of its Hybcell Inflammation integrated sepsis monitoring test. That test, which has been available solely for research, contains 12 protein biomarkers related to inflammation, and is sold for use on the firm's' Hybcell cylindrical microarray platform.

The addition of suPAR as the 13th biomarker to the panel should attract more interest from hospitals that will use the updated assay in more critical situations, as well as for general surveillance.

According to Reschreiter, Anagnostics and Virogates hoped to conclude assay development by next fall. He added that Anagnostics hopes to obtain a CE-IVD mark by the end of the year for the product, which will be sold with the name Hybcell Inflammation Blood xB.

"Basically we see a widening in the intended use" of the test, Reschreiter said. "Beside intensive care units that are more interested in questions of daily monitoring ... there is a different need in emergency departments for tools that can be used in patient stratification, to test the severity or presence of inflammation, and to provide a prognosis," he said. "Here, suPAR comes into play, as this is the strong point of that marker."

According to Virogates, suPAR is a protein in the blood whose levels reflect immune activation and have been shown to be higher in patients suffering from several infectious diseases, including HIV, malaria, tuberculosis, sepsis, and pneumonia.

High suPAR levels are also associated with increased inflammation, disease progression, and an increased risk of mortality, Virogates states on its website. Measuring suPAR levels therefore can serve to determine a patient's chances for survival, as well as to monitor disease progression.

According to the company, suPAR has been "extensively clinically validated" and described in more than 300 publications for its ability to gauge inflammation severity.

Anagnostics currently sells a diagnostic called Hybcell Inflammation Blood xA. The test, which achieved a CE-IVD mark in the summer 2013, consists of six protein biomarkers related to inflammation.

The company's forthcoming test will not only be an expansion in terms of content, Reschreiter said, but also in terms of intended use.

"The extension of the test will target beside the inflammatory and anti-inflammatory markers more organ markers, some new kidney markers and other organs," he said. Reschreiter added that Anagnostics has run about 1,000 samples on the test and claims the company can demonstrate that multi-marker tests are "superior in their prognosis in comparison to single markers," he said. The firm hopes to publish the results of this study later this year.

Founded in 2005, Anagnostics' platform is a bit different from some others on the market. While most arrays are printed on slides, Anagnostic's Hybcell arrays are composed of detector molecules, DNA or proteins, which are immobilized on the surface of an inner cylinder. This cylinder is enclosed within another external cylinder, which users fill with their sample. Up to 96 Hybcell arrays can be processed at a time in the company's Hyborg system, which integrates a thermal cycler, a hybridization station, and a scanner.

In more recent years, Anagnostics has focused increasingly on the European molecular diagnostics market, attaining CE-IVD marks for its Hybcell Bacteria DNA xA and its Hybcell Fungi DNA xA, both of which are intended for pathogen testing. The company also offers tests to screen for drugs of abuse, as well as companion diagnosticssuch as CE IVD assays for KRAS mutations related to colon cancer and BRAF mutations related to lymphomas.

Looking ahead, Reschreiter said that Anagnostics is clinically validating a panel for orthopedic and joint infectionsand one for dermatological pathogenic fungi.

"We are expecting to release both tests as CE-IVD in the middle of this year," he said.

Anagnostics will also present expanded versions of its septic pathogen tests for bacteria and fungi and a new test for antibiotic resistance markers at the European Congress of Clinical Microbiology and Infectious Diseases meeting to be held in April in Copenhagen, Reschreiter said.

In addition, Anagnostics intends to grow its distribution network in 2015. The company currently covers sales directly in German-speaking countries, and has distributors in Belgium, Denmark, India, Latvia, Norway, Sweden, and Turkey. Reschreiter said that Anagnostics will add new distribution partners in Europe and the Middle East in the coming year.

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