STMicroelectronics, a Geneva, Switzerland-based semiconductor manufacturer, is preparing to enter the biochip market with an application that harnesses ink-jet technology — not for arraying DNA probes onto a glass substrate, but for shuttling fluids about on microchannels etched deeply into a silicon chip.
The company has a working prototype lab-on-a-chip product and is targeting the nucleic acid market, and the technology of low-density microarrays as its competition when the chip and related instrumentation roll out in 2005, Stefano LoPriore, business development manager for the product, told BioArray News in a telephone interview last week.
This global company, which creates silicon chips that go into cellular telephones, cars, hard-disk drives, DVD players, and smart cards, for example, is just the latest silicon chip maker with hopes that it can translate the skills, practices, and methods of mass-manufacturing integrated circuits on silicon into the mass manufacture of biological probes on silicon. The queue is large and includes Intel, the industry’s giant, which is exploring its options (see BAN, 2/28/2003) as well as the semiconductor industry of Taiwan, which is preparing to roll out a mass-manufactured microarray under the leadership of the Phalanx Technology group (see BAN, 7/9/2003).
“Our goal is [to] become a platform provider to enable developers of genomic content to deliver that content to users — for example, reference labs in the diagnostic market,” LoPriore said. “Our expertise in handling and moving and heating and cooling liquids on a microscopic scale comes from the ink-jet market.”
The company, which has developed a number of working prototypes, hopes to begin validation tests on its biochip and instrument platform in the latter half of 2004, and commercialization in 2005.
While no product name has been chosen, the biochips are being shepherded to market by the company’s ink-jet printer division.
The idea for the product, however, originated in 2000 in the company’s R&D center, based in Catania, Italy, and which continues to research silicon-based MEMS and microfluidics technologies.
The prototype today is an inch square and can handle 2.5 microliters of fluid. It is intended for one-time use and readable on an STMicroelectronics instrument, which is also in development.
The first commercial application the product will target is bacterial identification, LoPriore said. “Right now, we are targeting infectious diseases, like [those] found in intensive care units.”
At the core of the chip are channels created in the silicon underneath the surface that will contain the reagents that are needed.
“After performing sample preparation, the operator would inject the sample into the chip, which would then do all the operations that are currently performed in a lab,” said LoPriore. “All the oper-ator would have to do is come back and read the result and the chip would be discarded.”
The first data gathered will come from on-chip optics with electronic detection, also on-chip, to follow.
“Our goal is to be within an hour or less to get results,” he said.
Attacking the Market
The company is positioning the biochip to replace current tests performed in diagnostic labs, and for new applications, said LoPriore.
“We will go after replacement markets, where nucleic acid testing replaces existing technologies — for example, in vitro diagnostics and bacterial identification,” he said. New markets, where there are no tests today, could include food monitoring applications, and the identification of subspecies of cancer.
Pricing will depend on the application and the complexity of the test, but the company is targeting a sub-$100 price for the chip.
“Our research indicates that we would be competitive, but that also depends on the complexity of the chip,” he said. “It is possible to do multiplexing on the chip. There are also factors involved like reimbursement rates. Not all applications — though technically feasible — would have a commercial value. Some diagnosis would have a higher reimbursement rate that would justify a chip.”
The company is seeking a variety of partnerships, including content providers, beta-testers, and marketers.
“We are trying to leverage our manufacturing expertise and trying to leverage someone else’s marketing,” LoPriore said. “This is a very complex product that lies at the intersection of electronics, microfluidics, microbiology and medicine. We need strong partners.”
Any biochip platform that is intended for the clinical market will have to deal with the US Food and Drug Administration as a de facto partner. Currently, the agency is reviewing Roche’s introduction and marketing of the Affymetrix-built AmpliChip microarray product as an analyte-specific reagent (see BAN, 07/10/03). The consequences of that review, and other efforts within the agency, will certainly affect this product, as well as others.
“As of today, nobody has a 100 percent clear view of how the FDA will handle these devices,” said LoPriore. “The one thing that we like is that our device was designed from the start for the diagnostic market, rather than the drug-development market. We believe this will help us in tailoring our products for FDA approval. We are marginally involved in industry talks with the FDA. We have an on-going program to get FDA approval, but it will have to move in sync with validation efforts.”
LoPriore said that the company has a portfolio of patents surrounding the technology, which it will initially market in the US and Europe.
“There are a core of patents relative to this device and a series of processing patents, and patents on a number of other MEMS technologies that we use. I believe that there are a couple of dozen patents that are immediately applicable to this device, in the US and overseas,” LoPriore said.