Fresh from launching its array-based Prove-it Herpes diagnostic last week, Finnish molecular diagnostics firm Mobidiag said it plans to develop similar tests for sepsis and multiple bacterial infections.
The company said Prove-it Herpes, which tests for eight different human herpes viruses in a single sample, may eventually replace the slower, PCR-based assays currently used in European clinical labs and hospitals. These assays test for a single human herpes virus at a time.
According to Mobidiag CEO Jaakko Pellosniemi, Prove-it Herpes is now available for research use only, but the company believes it will receive a CE Mark by the end of the year.
Mobidiag’s upcoming sepsis and bacterial-infection tests will follow developmental course similar to Prove-it Herpes, Pellosniemi said last week.
“The herpes test is really the very first one that we have launched as a sellable product,” he told BioArray News. “It is available for customers … and we are now recruiting the needed hospitals for validation. By the end of the year we will have a CE Mark,” he added.
Prove-it Bacteria, as the next test is currently branded, should become available within one month, Pellosniemi said. The assay covers around 50 bacterial targets, and Mobidiag expects that it, too, will receive a CE Mark by the end of the year.
“We already have several hospitals signed for validating the bacteria test,” said Pellosniemi. “We are actually starting with clinical validations in April.” Pellosniemi did not discuss a timeline for the firm’s sepsis panel, but said that it is “very similar to the bacterial product.”
In 2005, Mobidiag partnered with ST Microelectronics to develop automated assays matching its content with that of ST’s In Check lab-on-a-chip platform. However, Pellosniemi said last week that the collaboration with ST is still in the development phase.
Instead, Mobidiag’s arrays will run on a system called TubeArray, which is manufactured by an undisclosed third company. To arrive at a test result, the Prove-It assay uses a PCR amplification step followed by a hybridization step.
The complete TubeArray system includes a laptop, a reader, and internally developed analysis software. According to Pellosniemi, TubeArray costs less than €15,000 ($23,130) while the herpes test costs around €70.
“That price is rather competitive,” he said. “A single herpes test might cost that in a hospital.”
Mobidiag said it hopes that the relatively small footprint of the TubeArray System, plus its competitive price, will be attractive selling points for European hospitals and labs. Once the CE Mark is in place for the herpes assay, Mobidiag will be targeting “big university hospital labs” in Europe, Pellosniemi said.
“There are about 600 hospitals in Europe that are capable of molecular diagnostics or have an interest in molecular diagnostics,” Pellosniemi said. “Hospitals are already doing these kinds of tests. For example, in the case of herpes, there are homebrew tests for a single pathogen. We can integrate all these tests into one. And hospitals have a much easier way of maintaining their tests,” he added.
Pellosniemi said that in terms of targeting microbiological labs, the firm is confident it could make the sell, despite the fact that RT-PCR tests are still more widely known than array-based tests. “The pricing is competitive. This has been one reason why the acceptance [of microarrays as diagnostics] hasn’t been that great in the past and are not in routine diagnostic use,” he said.
Pellosniemi also said that the two different kinds of labs that Mobidiag will target are becoming more open to using array technology. “Microbiological labs are divided in two,” he explained. “There are the bacterial labs and the viral labs. The viral labs are very advanced. They have been using molecular approaches for a decade by now and they are very familiar with these tools. Here the barrier is smaller,” he said.
“On the bacterial side, there is now a heavy interest in molecular methods,” he said. “The DNA extraction facilities around Europe are taking off strongly and we could say that at least half of the hospitals we are targeting have the facilities in place and they can perform these tests.”
To begin its sales and marketing efforts, Mobidiag has already begun making new hires. Last year, the firm added sales director Kari Kataja to its management team. Kataja previously served as a key account manager at Roche Diagnostics.
“We are now building the sales and implementation force. That is all now in place, so we are able to deliver and execute,” Pellosniemi said. He added that once Mobidiag builds a European customer base for its initial tests, it will begin thinking about entering the North American and Asian markets.
‘Agnostic About Hardware’
While Mobidiag’s trio of molecular tests will be deployed on TubeArray, the company is continuing a development project with ST Microelectronics to match its tests with ST’s higher-throughput In-Check platform.
In September 2005, the company discussed its plans to develop a sepsis diagnostic on the In-Check platform with a possible launch date of mid-2006. Pellosniemi told BioArray News at the time that the firm’s sepsis pathogen panel can identify 10 sepsis-causing bacterial species as well as methicillin-resistant strains of Staphylococcus aureus from positive blood culture samples (see BAN 9/21/2005).
At the time, Pellosniemi said that Mobidiag was prepared to introduce other applications for the In-Check platform, including diagnostic panels for pneumonia and meningitis “within the next one to two years.”
Last week, Pellosniemi said that Mobidiag and ST Microelectronics are “still working on the lab-on-chip solution, but that’s not out yet.” Instead, he said the firm had decided to use TubeArray as a platform instead for Prove-it Herpes.
“In a way we are agnostic about the hardware,” Pellosniemi said about the decision to go to market with TubeArray instead of In-Check. “We only develop the software and the applications; we are responsible for the branding, regulatory approvals, and the customer relationships,” he said.
Rob Hodges, director of new business development for ST's In-Check Platform, told BioArray News in an e-mail this week that the company is “making progress with Mobidiag, but does not have a forecasted product launch date at this time.”
However, this week ST and its partner Veredus Laboratories, a Singaporean molecular-diagnostics shop, announced the availability of VereFlu, an influenza virus test that is the first assay developed explicitly for the In-Check system (see sidebar).
Hodges said that “in addition to Veredus and Mobidiag, ST is working with a few other companies to develop applications for the In-Check platform.” He declined to provide more specifics on any of ST’s newer partners.