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Mobidiag Debuts New Array Platform, Prepares Herpes, Bone, and Joint Tests for CE-IVD Marks

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Mobidiag, a Finnish biotech firm developing assays that detect sepsis, herpes, and bone and joint infections, this week announced a new, higher-throughput platform.

The company, which last October achieved a CE-IVD marking for its sepsis-detection test, is also seeking CE-IVD marks for its herpes and bone and joint assays, according to a company official.

CEO Jaakko Pellosniemi told BioArray News this week that Mobidiag will next month begin shipment of its new Prove-it StripArray platform, which enables the readout of up to 96 samples at a time, a tripling of the throughput of Mobidiag's initial TubeArray platform that the company released in 2008 (see BAN 3/25/2008).

The company believes the higher-throughput, semiautomated StripArray platform will be attractive to the clinical laboratories it is targeting with its menu of tests by enabling users to run multiple tests in one assay. Mobidiag will continue to support the lower-throughput TubeArray platform, and the StripArray reader can analyze results from both platforms. Mobidiag's Prove-it Advisor analysis software is also compatible with both StripArray and TubeArray, Pellosniemi said. Both platforms are manufactured by the same subcontractor, he added.

"StripArray is much more cost effective for customers," Pellosniemi said of the need for the new platform. "With the old TubeArray reader, you would have to do the read-out of the results manually," he said. "StripArray does it with one button. You can leave the machine and do something else."

While reducing the cost and time associated with running its assays was one of Mobidiag's goals in launching the system, the company also needs to increase the number of pathogens it can screen in a test to meet the needs of its target customers.

"We are constantly expanding the panels we offer and there are many new application areas that require special kinds of targets to cover the whole problem," Pellosniemi said. "Consider bone and joint infections; by adding new bacteria to our sepsis chip, our assay can cover over 90 percent of all bone and joint infections," he said. "This is why we need bigger arrays."

Prove-it

Founded in 2001, Mobidiag launched its first research-use-only assays for sepsis and herpes last year. In October 2008, the firm successfully registered its Prove-it Sepsis assay with Finnish health regulatory agencies, enabling it to market the assay to EU clinical labs as an in vitro diagnostic (see BAN 11/4/2008).

This week Mobidiag announced the launch of its Prove-it Bone and Joint microarray assay, designed to identify bacteria responsible for bone and joint infections, which it markets as a complementary test to the Sepsis IVD.

Prove-it Bone and Joint can detect more than 64 bacterial species involved in infections such as osteomyelitis and septic arthritis, Mobidiag said. Osteomyelitis is the infection of bone or bone marrow, while septic arthritis is the infection of the fluid and tissue of a joint.
Typically, these infections are still identified by culture, which is time-consuming, and Mobidiag sees its platform as a step up from existing technologies. "Detecting these bacteria is very difficult today, and we feel that this assay is the right solution for hospital labs," said Pellosniemi.

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According to Pellosniemi, Mobidiag expects to validate Prove-it Bone and Joint over the summer, with the goal of achieving a CE-IVD mark in the third quarter. Prove-it Bone and Joint was developed and is being validated in co-operation with Hospices Civils de Lyon in France, he said. Because the bacteria it targets are similar to the ones detected by Prove-it Sepsis, Pellosniemi said Mobidiag can combine both assays on the StripArray platform, depending on the needs of its customers.

Mobidiag is also working with Hospital Districts of Helsinki and Uusimaa and the University of Helsinki, as well as other undisclosed hospital labs in the EU, to validate its Prove-it Herpes assay for use in clinical diagnostics, Pellosniemi said.

This week the firm announced that Prove-it Herpes "achieved excellent results in an international multicenter clinical evaluation study." The Prove-it Herpes assay can identify eight clinically significant herpes viruses in two hours, Mobidiag claims.

To evaluate the assay, 460 cerebrospinal fluid samples were run on the platform at six European clinical laboratories. Prove-it Herpes was compared to current PCR-based methods and "showed clinical sensitivity of 92 percent and specificity of 98 percent," the company said. In 20 of the 460 samples, the test uncovered pathogens not found by the reference methods, the company claimed.

Additionally, the test identified 12 multi-strain infections that were missed by standard PCR-based assays and identified 15 patients with an HHV7 infection not found by the reference methods, the company said.

Pellosniemi said that clinical evaluation of Prove-it Herpes is ongoing. The company expects to have the assay CE-IVD marked by year end.
All three assays will compete against a variety of tests being developed to replace older, more labor-intensive methods of infectious disease detection. For example, Jena, Germany-based SIRS-Lab has launched a multiplexed PCR test for sepsis called VYOO. VYOO received CE-IVD marking in December. In 2006, Cepheid had its Smart VZV assay for herpes identification CE-IVD marked. Like SIRS-Lab's test, Smart VZV is also a multiplex PCR-based assay.

Concentrating on Europe

While penetrating the North American and Asian markets is part of Mobidiag's long-term strategy, the company currently is focused on building up a customer base of hospital labs in the EU. Pellosniemi said that roughly 20 labs are already using the company's assays.
"Right now, our concentration is on Europe," said Pellosniemi. "But we do intend to go to the US and we are in the process of building networks there," he said. He did not elaborate on Mobidiag's plans to go beyond its home European market.

Either way, the firm is "well funded" to proceed with its business plans. Pellosniemi said the company closed a new round of VC funding at the end of 2008. He declined to elaborate. Pellosniemi told BioArray News last September that the firm was seeking additional funding to support its transition from a research-oriented company to one that could sell and market its products (see BAN 9/16/2008).

Mobidiag's current investors include SITRA, a publicly funded Finnish healthcare investment organization, as well as the University of Helsinki.

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