Bruker Biosciences, under an alliance with Isis Pharmaceuticals announced this week, will soon begin manufacturing and selling a sophisticated biosensor system that can simultaneously identify thousands of types of infectious organisms in a single sample.
The new instrument, called the Ibis T5000, will include Bruker’s micrOTOF-ESI-TOF mass spectrometer and will add “an advanced application” to the firm’s portfolio of products, according to a company spokesperson. Although Bruker has expressed an interest in eventually selling its instruments in the diagnostics market, it appears Isis will seek a partner with more experience than Bruker in selling to that market.
“There are quite a number of primary applications for [the instrument], whether it’s pharmaceutical research, or biodefense, et cetera,” said Michael Willett, the Bruker spokesperson. “We’re kind of interested in [diagnostics], and we’re looking at that area, and hopefully we’ll be doing more in that area.”
During the past year, Bruker signaled its intent to enter the diagnostics market by registering certain of its mass spectrometers with regulatory authorities in South Korea and Russia, hoping to facilitate approval of mass spec-based in vitro diagnostic assays in those countries (see BioCommerce Week 8/18/2005).
Under terms of the agreement with Isis, Bruker gained exclusive worldwide manufacturing rights for the biosensor and is responsible for order processing and system installations and service in North America, Europe, and the Middle East. The firm also has exclusive rights to sell the instruments and infectious organism identification kits in Europe and the Middle East for various government applications, and non-exclusive rights to sell to all other customers, including clinical, pharmaceutical, and academic researchers for applications other than diagnostics.
There’s no official launch date for the new system, though Isis has already placed instruments with grant collaborators and some government agencies, according to Kate Corcoran, vice president of corporate development for Isis Pharmaceuticals. She said when the instrument is commercialized it will list for between $350,000 and $450,000.
“Over the next six months we’ll be transitioning the full manufacturing of the instruments to Bruker, but during that time we’ll still be deploying the units as necessary,” she said. “We do expect to have our first commercial sale this year, but that unit is likely to be somewhat hybrid in terms of its assembly process. Whether it’s entirely Bruker or not remains to be seen, based on timing.”
Eyeing an Experienced Dx Partner
“Our plan strategically is going to be to engage a partner for marketing to the diagnostics market who will help us with our manufacturing plan for that.”
The T5000 biosensor system has not been cleared by the US Food and Drug Administration for diagnostics use, but Isis plans to seek such approval at an undetermined time in the future. Comments by Corcoran suggested that Bruker would not be an ideal partner for the diagnostics market.
“Our plan strategically is going to be to engage a partner for marketing to the diagnostics market who will help us with our manufacturing plan for that,” she said. “Mainly, we wanted to leave it open because if that partner … also had instrumentation manufacturing expertise, we wanted to have the option of keeping that,” rather than granting Bruker those rights at this time.
“There’s not a time urgency [in signing up a diagnostics partner] because we’re not imminently ready to market in the diagnostics area,” said Corcoran. She added that the firm would be considering a partner already in the in vitro diagnostics market with experience selling to hospitals.
Corcoran also said that she believes the Ibis T5000, in its current form, “is appropriate for the diagnostic market.” But, she quickly noted the firm cannot make any diagnostic claims without FDA approval. “In the timeframe between now and when we achieve that, whether there are design improvements on the engineering side, I couldn’t really say,” she said.
The T5000 was developed by Isis’ Ibis Biosciences division and is based on a methodology that combines genomics, mathematical modeling, mass spectrometry, and molecular amplification to generate a fingerprint of each bacterium or virus.
The firm has already placed instruments with the US Army Medical Research Institute for Infectious Disease, which will use it for biowarfare defense purposes, and the Department of Homeland Security’s National Bioforensic Analysis Center, which will use it for investing crimes involving infectious organisms. Isis has partnerships with several other government agencies for developing applications for the biosensor system, but it is hoping Bruker will help spread its use among pharmaceutical and academic customers.
The T5000 is the second biosensor system that will be sold by Bruker. Earlier this year, the firm launched its own MALDI BioTyper system for identifying and classifying microorganisms. That instrument is used for taxonomical research on microorganisms, infectious disease research, and to detect and identify microorganisms in environmental analysis, food safety, and water quality.
The T5000 will compete against other instruments that use real-time PCR quantification and some custom microarray hybridization types of assays, said Corcoran.
“But there’s nothing I am aware of that has the capabilities this does,” she said. “There are other approaches to infectious disease surveillance, but nothing that … approaches it from a mass spec universal biosensor point of view.”