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Axela Partners with Hutman Dx to Develop Automated Multiplex Pathogen Detection System

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Axela and Hutman Diagnostics have announced an agreement that will deliver a microarray-based, sample-to-answer pathogen detection platform to market next year.

Basel, Switzerland-based Hutman already sells pathogen detection kits that include arrays printed on glass slides that are processed manually using commercially available equipment as well as Hutman's proprietary software.

By integrating Hutman's kits and software with Axela's automated Ziplex system, the companies hope to reduce the amount of time it takes to identify disease-causing pathogens, leading to a decline in associated healthcare costs and more effective use of antibiotics, according to Axela CEO Paul Smith.

Smith told BioArray News that the companies plan to make assays for endocarditis, pneumonia, fever, and meningitis available on the Ziplex system, though they have longer-term goals to expand into food safety and veterinary testing.

Hutman, which was established in 2011, has already launched an endocarditis in vitro diagnostic in its slide array format called Endo-cardi Gene.

By moving to the Ziplex, users will obtain "automation and the ability to run a broader menu of tests including nucleic acids and proteins, both antigen and antibody, detection," Smith said.

Hutman will continue to offer its tests in its existing slide-based array format, "to allow customers the greatest flexibility to accommodate individual throughput requirements," Smith added.

Toronto-based Axela's Ziplex system is based on the firm's flow-through microarray technology, which enables target solutions to be passed back and forth through more than 200,000 microchannels contained within its porous silicon-made TipChip consumables. Using the Ziplex, users can look at between five and 250 targets per sample, according to the firm.

Axela claims the flow-through approach results in hybridization or protein binding that is four times faster than conventional, slide-based microarrays. The Ziplex automates the hybridization or protein binding, washing and labeling, and imaging steps of these assays.

Smith said that Axela and Hutman expect to be able to place a first-generation offering with customers by the end of this year. It will consist of the Ziplex paired with a manual sample preparation kit. In the second half of 2014, the company plans to have an integrated system available for the test that "provides sample-to-answer from whole blood," Smith said.

While both companies intend to market the combined offering, Smith said they are in discussions with potential partners who "already have [the] commercial infrastructure in place to address these specific [pathogen detection] market segments."

While Smith declined to comment on these discussions, he said that data from initial proof-of-concept studies across multiple pathogens could be used as part of a regulatory submission in cooperation with its unnamed partners. He also said that the data from these studies would be published, though he did not elaborate.

Smith did not disclose the cost of the new system, but said that the firm has over the past year reduced the price of doing an assay by cutting down on production costs and increasing assay specificity and sensitivity. On the website, the firm portrays the Ziplex as an alternative to "expensive, high-density" microarray systems.

Smith added that Axela believes the pathogen detection tests it develops with Hutman could be inexpensive enough to be used eventually in "developing regions of the world where the cost per test is challenging," adding, "We see that as an area where our cost structure will be able to compete."

Thermal Gradient complement

According to Smith, Axela's relationship with Hutman could complement a separate deal it announced earlier this year.

In July, Axela said that it would work with Rochester, NY-based Thermal Gradient to integrate Thermal Gradient's PCR technology into Axela's flow-through microarray workflow.

According to a statement, Thermal Gradient's sample preparation and amplification technology will be combined with Axela's approach for the capture and quantification of targeted nucleic acids. According to Axela, its approach has been optimized for formalin-fixed, paraffin-embedded tissue samples, and has been developed to work with other biopsy samples, blood, and isolated cells.

While the objective of Axela and Thermal Gradient's partnership is to develop an integrated sample preparation system for gene expression in FFPE tissues, supporting "complex molecular oncology tests," Smith noted that the components of the system "have been designed to accommodate a broad range of sample types" and "will be incorporated into the cartridge for detection of bacteria and viruses from whole blood."

Also earlier this year, Axela said that it was working with an investment bank to evaluate different strategic options. Specifically, the firm said that it had appointed AmeriTech Advisors' healthcare investment banking team to respond to "recent strategic interest" from life science industry companies.

When asked for an update on that process, Smith said that the company successfully closed an initial round of financing over the summer, and "continues to pursue additional funding with strategic investors to capitalize on further market expansion opportunities."

Smith did not disclose the funding amount.

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