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Anagnostics, Focusing on Integrated Sepsis Diagnostics Business, Eyes Opportunities in the EU, US

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Anagnostics is planning to expand its sales and marketing activities in the EU as well as the US as it narrows its focus to its nascent integrated sepsis diagnostics business.

The St. Valentin, Austria-based company, which bills itself as the developer of the world's only cylindrical microarray, also offers a number of companion diagnostics, but it has chosen to seek partners to develop the market for those tests while it explores opportunities for its sepsis menu.

CEO Christoph Reschreiter discussed Anagnostics' business goals with BioArray News this week. He said that the company restructured last year in line with its emphasis on the sepsis testing market, but it is ready to grow again as it seeks out customers.

"For this relatively new field of sepsis diagnostics, we had to do our homework first, to work with first adopters, to convince them to do a lot of clinical validation at different clinical sites. So it did not make sense to be too quick with market expansion, but now it is time to make that move, to expand the organization again," Reschreiter said.

Anagnostics has disclosed at least one partner that already uses its sepsis tests, the Christian Doppler Laboratory for Innovative Therapy Approaches in Sepsis in nearby Krems, Austria.

Established in 2006, Anagnostics was initially a technology development company. Its Hybcell microarray differs greatly from most standard array formats in that DNA oligos or antibodies are immobilized on the surface of a cylinder. Test samples are pipetted into cylindrical cartridges, and the reaction is carried out as the inner cylinder is rotated within the firm's Hyborg instrument. Reschreiter has compared the assay to "stirring while cooking," leading to improved reproducibility and a reduction in hybridization times.

Anagnostics has explored a variety of uses for the Hybcell platform through the years, as it has transitioned into a molecular diagnostics company centered on the unique aspects of its platform. In addition to sepsis testing, it has developed pharmacogenomic assays as well as drugs-of-abuse panels. But sepsis remains the most potentially lucrative prospect for the company, which hopes its tests will win it customers across Europe and North America.

Anagnostics recently attained a CE-IVD mark for its Hybcell Fungi DNA PlexA test, which can be used to detect roughly a dozen fungi associated with sepsis. Anagnostics said at the time that the test can be used in combination with its Hybcell Bacteria DNA PlexA test, which attained a CE-IVD mark in October 2012, and "perfectly complements [our] product portfolio in the area of integrated sepsis diagnostics." In addition to the Fungi and Bacteria products, an inflammation monitoring test rounds out the firm's current menu of sepsis-related tests.

All of the assays have a turnaround time of four hours and are run in conjunction with Molzym's SepsiTest sample preparation kit and a combination of PCR and on-array compact sequencing to detect and quantify pathogens in a blood sample. Anagnostics announced its relationship with Bremen, Germany-based Molzym in 2012.

The company also offers a number of drugs-of-abuse screening panels and will continue to offer those, but its focus is clearly on the market for sepsis tests, Reschreiter said.

"With sepsis infections, it is a matter of life and death, and so the offer we can make as a company is much clearer," he said.

The CE-IVD marks should aid Anagnostics in its quest to build out its European installed base, but another factor is the company's switch to a direct sales strategy.

"Within two-and-a-half years we want to be present all over Europe," Reschreiter said of the firm's sales ambitions. "We have our own sales force on the ground in Austria and Germany and this is a strategy change, reducing efforts to find partners, but to approach the market on our own," he said. "As we have learned, in taking initial steps it is very crucial to do it yourself, to find customers and get feedback and respond to that feedback."

Anagnostics is also mulling expansion into the US. Reschreiter said that the company will engage the US Food and Drug Administration to see what it might have to do to achieve clearance for its sepsis-related assays. The company is also exploring relationships with local partners to help it build its US business. However, Reschreiter declined to provide a timeline for a potential FDA submission.

As it looks to broaden its sales and marketing activities and reach US customers, Anagnostics is developing an additional sepsis-related assay for monitoring a patient's response to antibiotics.

"At the end of the day, we want to be the diagnostic company that provides everything you want to know in the case of sepsis," said Reschreiter, "and that goes into the monitoring of [a] patient and the reaction of the patient to therapy."

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