Two years after it vowed to deliver a microarray for use in diagnostics sometime in 2005, Swiss semiconductor giant STMicroelectronics is on track to make good on its promise (see BAN 10/15/2003).
A company official told BioArray News last week that ST has partnered with a European molecular diagnostics firm, and its chips will be commercialized before the end of the year as part of an in vitro diagnostic test for sepsis.
Rob Hodges, the company's product development manager, said that ST had partnered with MobiDiag, a Helsinki, Finland-based molecular diagnostics firm, and its debut microarray offering would be part of MobiDiag's Prove It! Test for sepsis.
The array is on printed circuit board material, which is "being sampled by MobiDiag with the design to detect strains of bacteria for infectious diseases," Hodges said.
According to Hodges, the arrays are due out by the end of this year in Europe and will constitute ST's 'initial sales' in the microarray field. ST itself will not seek regulatory approval for the products. Hodges said that ST may commercialize the platform in the US with other partners as well.
Jaakko Pellosniemi, president of MobiDiag, last week told BioArray News that the Prove It! Test will also be a first for his company. The 5-year-old firm is making the transition from R&D to selling its first product, and has decided to take a stab at placing its kit for sepsis in clinics across Europe.
"The most interesting market for us is the infectious disease market, and in the infectious disease market we have also chosen a very narrow niche market. We are targeting only serial infections, like our first product for sepsis," Pellosniemi said. There are no current plans to submit the test to the US Food and Drug Administration, and Pellosniemi was unclear about the company's effort to get the test cleared in Europe.
Due to the multiplexing capabilities of ST's chips, "one of the strengths of the [Prove It! kit] is that it can detect several pathogens at the same time," he added.
Hodges also said that ST will be able to draw upon its manufacturing infrastructure to keep the cost of the chip, and thus the cost of the Prove It! Test, at a fraction of competitive arrays.
"Because we have a low-cost/high-volume manufacturing infrastructure within ST, we believe that we can have a rapid cost versus cumulative volume learning curve, Hodges explained.
"We are targeting an array about one-tenth the price of current microarrays." Hodges pointed out that the platform also includes a low cost reader.
"We do believe that we can provide chips that will enable tests for less than $100," he said.
Pellosniemi said another reason that the Prove It! Test will be in the price range of large European, and perhaps American, labs the company is targeting is because its reader and bioinformatics package will be available for less than the average market price.
"Our bioinformatics and the device that we are using for the PCR allow us to use low-cost devices," said Pellosniemi. "Today's cheapest reader devices cost about €50,000. We want to be able to provide a product in a completely different price range," he said. Pellosniemi declined to speculate on an approximate price.
While both Pellosniemi and Hodges declined to discuss how far their business relationship may extend, Pellosniemi said that MobiDiag plans to release Prove It! kits for other infectious diseases such as meningitis and pneumonia following the release of the sepsis kit .
Pellosniemi also said that the company had been working towards developing array-based kits for food identification and environmental testing, but that he could not announce anything yet.
Hodges also said that ST was exploring undisclosed alliances with "additional partners" for food control.
The company has also beefed up its microarray sales force and R&D employees, according to Hodges, growing from seven to 30 people in the unit over the past 18 months.
A Long Queue
Most array companies believe their technology will play favorably in the market for molecular diagnostics, and Hodges and Pellosniemi are no different. When looking at the field of competitors lining up to use microarray-based IVDs for sepsis, it appears that MobiDiag is not the only company that sees the potential to play in a field that, according to Pellosniemi, hasn't seen much technological advancement since the advent of culturing and X-rays.
In recent months, larger players such as Germany's SIRS-Lab and France's BioMerieux have been consolidating their partnership with chip vendors and have hinted at future launches of IVDs for infectious diseases, including sepsis.
In March, SIRS-Lab licensed array IP from Oxford Gene Technology to begin manufacturing and distributing its own array systems for infectious diseases and sepsis.
In addition, BioMerieux recently expanded its contract with Affymetrix to permit it to use Affy technology to create and distribute diagnostics for breast cancer. The agreement is built on an original deal between the two companies that allowed BioMerieux to use Affy technology to develop and sell tests for infectious diseases, including sepsis.
While BioMerieux has declined to respond to many requests for information about the tests it has developed on the Affy platform, Dirk Lammerts, Affy's vice president of molecular diagnostics, told BioArray News last month that he expected that many of the technologies being developed by companies such as BioMerieux and Veridex, a J&J company also working on a diagnostic test, would be coming to market shortly.
Another group using Affy chips to investigate sepsis is the Inflammation and Host Response to Trauma Network, a consortium of 70 researchers from 20 US research and medical facilities.
That network recently published a paper in Proceedings of the National Academy of Sciences on standardizing their data gathering practices. They are interested in applying genomic technologies, especially microarrays, to sepsis and septic shock.
Yet another company poised to enter the market with a test for infectious diseases, including sepsis, is Mulkiteo, Wash.-based CombiMatrix, which has developed a multiplexing test for infectious diseases through a two-year contract with the US Department of Defense.
According to CombiMatrix' David Danley, who is overseeing the creation of the detection system, the test will probably be ready for use in identifying infectious diseases and commercially available before the end of next year.
— Justin Petrone ([email protected])