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Anagnostics Pursues CE-IVD Mark for Pathogen Array; Developing Next-gen Compact Sequencing

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NEW YORK (GenomeWeb) – Austrian molecular diagnostics firm Anagnostics recently launched a new assay designed to detect sepsis-associated bacteria and fungi using a single array.

The company is also considering creating other arrays containing multiple test panels, though their future is linked to the creation of a new compact sequencing application the firm has in development.

Christoph Reschreiter, cofounder and CEO of St. Valentin-based Anagnostics, discussed these items and the company's broader outlook in an interview with BioArray News this week. Anagnostics' latest assay, called Hybcell Pathogens DNA, enables the detection of 19 bacteria groups and 11 fungi on one of the firm's cylindrical array cartridges.

Reschreiter said that the assay is currently available for research purposes, but will obtain a CE-IVD marking by the end of the year, making it possible to use the test in a clinical setting in European countries.

Unlike most arrays which are deposited on planar surfaces, Anagnostics' Hybcell platform consists of DNA oligos or antibodies that 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, leading, according to Reschreiter, to improved reproducibility and a reduction in hybridization times.

Anagnostics has sought to parlay these technological advantages into products for the molecular diagnostics market, focusing on sepsis, drugs of abuse, and pharmacogenomic testing in particular. In April, it achieved a CE-IVD mark for Hybcell Fungi DNA PlexA, which can be used to detect roughly a dozen fungi associated with sepsis. The company markets this assay as a companion to its Hybcell Bacteria DNA PlexA test, which attained a CE-IVD mark in October 2012.

The Hybcell Pathogens DNA test marries the content of both of these assays, providing flexibility to laboratories that conduct sepsis testing, Reschreiter said. "The advantage is that you only have to use one cartridge, instead of two," he said. "There is also some price discrimination," he added. While Reschreiter would not disclose the price of the tests, he said that the Hybcell Pathogens DNA test costs less than the combined price of the Hybcell Fungi DNA PlexA and Hybcell Bacteria DNA PlexA tests.

While some labs have moved to Hybcell Pathogens DNA for its consolidated content and price differential, Anagnostics has no plans to retire the other tests, as some customers typically test only for fungi, while others are more focused on bacteria, Reschreiter said.

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

Given its ability to combine multiple tests onto one cartridge, Anagnostics is weighing the possibility of combining some of its other assays to offer the market a variety of tests. Some of the firm's various pharmacogenomic assays for cancer-associated mutations in the genes KRAS, BRAF, and EGFR could also be consolidated into one assay, he said. However, Anagnostics aims to offer such tests only after it concludes the development of its next-generation compact sequencing application.

At present, the firm's on-array compact sequencing approach relies on obtaining a small amount of sample, amplifying it via PCR, labeling it, and transferring it onto Hybcell arrays, and processing those using the Hybcell platform. The amplified DNA then binds with immobilized primers on the surface of the array. In the case of a perfect match, the primers are lengthened by a highly-specific polymerase. The measured values are then interpreted by the software and displayed in tabular form in a report covering the measurement range. The values are expressed as the proportion of mutant to non-mutant DNA.

According to Reschreiter, Anagnostics is currently working on a new compact sequencing method where DNA amplification and detection will both occur within the cartridge. "We are currently using on-spot primer extension and melting curve analysis, and we are developing a way of performing amplification on the spot," said Reschreiter. "We see it as a workflow issue, [and] we aim to facilitate the workflow tremendously," he said. "At the end of the day, you won't need to worry about separate amplification steps," he added. "Then it might make sense to combine KRAS and BRAF in the same cartridge."

It may take some time before Anagnostics' customers can take advantage of this newer approach, however. Reschreiter estimated that it may take several years before the application is ready for commercialization.

"Our long-term focus is on next-generation compact sequencing," said Reschreiter. "This is the direction where we want to put our efforts in the next two to three years."

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