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As ABI Unveils New Mass Spec for Metabolomics Market, Can It Convince Big Pharma to Buy It?

SAN FRANCISCO — Applied Biosystems last week launched the API 5000 LC/MS/MS System, a triple-quadrupole mass spectrometry platform co-developed with MDS Sciex that will serve as ABI’s flagship product for the emerging metabolomics market.

The company rolled out the $450,000 instrument and software platform as Cathy Burzik, ABI’s president, presented at the JPMorgan Healthcare conference last week.

The API 5000, part of the company’s protein and small-molecule division, is a product of ABI’s 50-50 joint venture with MDS Sciex Instruments. ABI is positioning the instrument as a complement to its existing $395,000 API 4000 mass spec instrument.

But an immediate question that arises centers on ABI’s strategy to market the new instrument. Specifically, will customers — which ABI said will include deep-pocketed but notoriously finicky drug makers — buy the more expensive unit when the 4000 system can be had for $55,000 less?

The API 5000 will compete with Thermo’s Quantum Ultra AM and Waters’ Quattro Premier triple-quads, and targets customers in pharmaceutical and contract research organizations conducting research in pharmacokinetics and ADME/tox.

“It’s an additional product, not a replacement,” Burzik said. “We are targeting traditional pharma with its appetite for more and more sensitive mass spectrometry systems.”

Laura Lohman, president of ABI’s proteomics and small-molecule business, said she expects a “ramp-up” time for customers to first test the technology before purchasing, but said units are available.

The product launch refreshes the top of ABI’s quantitation applications for mass spectrometry and fuels its strategy for addressing the emerging metabolomics market, which it lists alongside genomics and proteomics as an enabling technology for systems-biology research.

Mass spectrometry sales made up 24 percent of ABI’s revenues in FY 2004, growing 17 percent compared to the previous year, but trailing revenues from the company’s top selling DNA sequencing and real-time PCR products.

Emerging Market

Metabolomics is regarded as a collection of platforms and applications with blurry, imprecise market demographics. The field addresses the measurement of small molecules that exist in complex mixtures and at many levels of concentration in cells, tissues, and biofluids such as blood, urine, and saliva.

There is no single platform on the market today that can measure all metabolites, and approaches to this type of analysis include the use of nuclear magnetic resonance, chromatography, and mass spectrometry, each of which has significant limitations in quantification, scope, and/or throughput.

John Ryals, CEO of Metabolon, a Research Triangle Park, NC-based early-stage firm focusing on metabolomic analysis techniques, said mass spectrometry instrumentation is one hardware solution for identifying small molecules. But, he said, there is not one machine that will currently do it all.

“It’s not going to be one type of mass spec that will do a full analysis” of metabolites, he said. “You will need various different types. I can’t imagine any setup where you can take an extract and get everything you wanted. That’s the dream machine — but it may be the impossible fix.”

But, he said, the technology is set to develop rapidly.

“Within the next year or two a bunch of instruments are going to come out with a resolution of a million,” he said. To understand the power of that level of resolution, he said, take a molecule with a molecular weight of 300 Daltons, and divide that by a million.

But, he said, precision, reproducibility, and analysis are also critical issues yet to be resolved by today’s technology.

“You can’t just buy an instrument and get it to work,” he said. “You have to process the signals and extract the information.”

When Metabolon purchases a new mass spec, “we recode it,” he said.

“We sidestep the software,” he said. “It’s designed for 90 percent of the market, and we are doing something different.”

In ADME/tox and pharmacokinetics, investigators know what information they are seeking in samples and instrument sensitivity is a critical attribute, he said.

Contrary to ABI’s strategy of “targeting traditional pharma,” Ryals sees CROs and reference laboratories as the best likely customers for the technology; for Ryals, pharma is not moving toward metabolomics analysis.

“Unless you have the window into the data, you just have a black box,” said Alan Higgins, senior director for investigational medicine at Icoria, another RTP firm engaging in metabolomics analysis. “There is a lot of skepticism about a turnkey system coming out in the next few years.”

— Mo Krochmal ([email protected])

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