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ST to Release Instrumentation for Mobidiag IVD, Seeks Other Applications for New Business Model


BOSTON — Swiss semiconductor giant ST Microelectronics will release its In-Check microarray platform in conjunction with the first application for the system, an in vitro diagnostic created by ST partner Mobidiag, an official from the company told BioArray News here last week.

Stefano LoPriore, the business development manager of ST's microfluidics division, said that the company now sees the benefit in making the entire system — including the PCR system, scanner, and informatics — available, rather than just the chips, as had been earlier promised by the company (see BAN 5/18/2005). LoPriore spoke with BioArray News during IBC's Chips to Hits conference here last week.

The move is a reversal from ST's earlier model, where the company saw itself as a chip vendor, not an instrumentation provider. Still, the new business model seeks to exploit the same advantages as ST had when it imagined it would solely be selling arrays, especially with regards to cost.

"We realized that you had to give a complete system solution. That's where the value was," LoPriore said. "Our set of instruments is much more affordable than some instruments you had to use before. We will offer instruments at approximately three to five times less than competing microarray scanners," he said.

"Most microarray scanners have been designed for the R&D market. They have more applications than needed for dealing with low-density arrays."

Though LoPriore declined to discuss specific prices, he did say that ST will be able to make the instrumentation available at lower cost because it will have fewer features than traditional array instrumentation.

"Most microarray scanners have been designed for the R&D market. They have more applications than needed for dealing with low-density arrays," LoPriore said.

ST has promised a similar competitive price for its chips. In an interview last spring, ST's product development manager Rob Hodges said, "because we have a low-cost/high-volume manufacturing infrastructure within ST, we believe that ST [is] targeting an array about one-tenth the price of current microarrays. We can have a rapid cost versus cumulative volume learning curve."

During that interview, Hodges said that ST would make a low-cost reader available. Last week, LoPriore said that the offering now includes ST's Thermal Control System (TCS) which, according to a statement released last week, uses five control modules to monitor and adjust the PCR reaction in the experiment.

The signal is read optically by a portable reader, and each system will come with informatics that LoPriore said are customizable so that a clinical diagnostics lab can modify the results page for its customers.

Standard throughput on the ST platform will be five low-density arrays per experiment, but LoPriore said that by adding a TCS unit the output could be doubled. Foreseeing an increase in demand following the release of In-Check, LoPriore said that ST Microelectronics will add customer support hubs in major regional markets as the number of its customers increases.

Prove It!

The first application based on the In-Check platform will be a diagnostic panel from Helsinki, Finland-based Mobidiag that enables the DNA-based detection of sepsis-causing bacteria.

Called Prove It!, the pathogen panel can identify 10 sepsis-causing bacterial species as well as methicillin-resistant strains of Staphylococcus aureus from positive blood culture samples, according to a statement from Mobidiag and ST.

Jaakko Pellosniemi, the CEO of Mobidiag, told BioArray News this week that his firm plans to commence clinical trials early next year and that the test panel should be available for use in clinical diagnostics labs by mid-2006.

"We have several hospitals already on board that are doing the validation, and we have been working already for a long time with patient samples. We are here in Helsinki and we have very good connection to surrounding labs and university hospitals," Pellosniemi said. He added that there was "significant interest" among hospitals and labs in Central Europe and in the US for validating the tests and that he didn't view the validation studies as "a major obstacle."

In addition to the panel for sepsis, Pellosniemi said that Mobidiag is prepared to introduce other applications for the In-Check platform.

"In addition to sepsis, we are planning to launch diagnostic panels for pneumonia and meningitis within the next one to two years," Pellosniemi said. He said that Mobidiag could change the pathogens on the panel with relative ease.

"When we are able to push down the price for the whole system, we are also targeting more [common] infections like respiratory tract infections or urinary tract infections," he said.

Mobidiag's plans appear to mesh well with ST Microelectronics'. LoPriore told BioArray News last week that the firm had both short-term and long-term plans to introduce a variety of applications on the In-Check platform.

"We envision a future of several different applications running on the same platform," LoPriore said. "ST will not develop biology. We make it easier to deliver information to your customers," he explained.

LoPriore said that ST is in discussions with other content providers for diagnostic assays, but he declined to reveal their identities or what content they would offer. He said that ST has a short-term goal of working with providers on assays for sexually transmitted diseases, food testing, and biodefense, but that its long-term vision is to move the In-Check platform into the clinic, providing personalized medicine at the point of care.

— Justin Petrone ([email protected])

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