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ABI Launches Expression Array System With an Eye to Boosting Product Lines

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When Applied Biosystems brought to market its new microarray analysis platform in April, the company also opened up new lab facilities, where prospective customers can supply samples for gene-expression analysis on the company’s new Expression Array system.

“It’s a test ride, in essence, a dare to compare,” Kevin Cannon, ABI senior director for microarrays, told BioArray News last week.

The company confirms sales of the new product, but is not divulging specifics for the limited time that the product has been commercially available, and is optimistic, judging from the queue it has for its sample analysis demos.

“We are very pleased since the [product] introduction in April, and I think it is demonstrated not only in the sales, but that our laboratory here is actually well supplied with samples from customers,” Cannon said. “Our comparison and our value proposition of the most complete annotated genome-wide survey in one experiment has worked very well, and we continue to get samples daily as we start to expand our presence in the marketplace.”

(For a description of Applied Biosystems’ new platform technology, please see BAN 11/5/2003)

Almost a year ago, ABI announced that it was developing this technology, and in doing so, ignited (see BAN 7/28/2003) a microarray industry race to be the first to shrink a whole human genome assay onto a single chip and then sell it, widely.

In the 259 days between its announcement of the technology, and April 5, 2004, when the Expression Analysis system officially became commercially available, Applied Biosystems has engaged in an internal race to conclude development, prepare and train its sales force, manage customer testers of the product, and conduct a marketing campaign of tease ads and high-level industry presentations.

The company had originally targeted the rollout of the system for year’s end, but missed that by 95 days, while the top tier of competitors in the microarray industry — Affymetrix, Agilent Technologies, Amersham Biosciences — raced to the finish line. All now are in the single-chip, whole-human-genome marketplace as Applied Biosystems officially arrives. Affymetrix, the market leader, lists its single-chip human GeneChip — which has been available, it says, since October — as its flagship product.

“Being first to market doesn’t always confer competitive advantage,” Cannon said. “In a way, we have an opportunity to see what has captured attention within the research community and where the traction is.”

The company will follow the commercial rollout of the platform with the introduction of a single whole-mouse-genome chip perhaps as soon as this week, then plans to release a whole-rat-genome chip this summer, the company said.

“Our goal over the next three to five months is to conduct some fairly detailed market research and understand specifically what those markets are, and what they are working on,” said Clark Mason, senior product line manager for gene expression arrays. “That will, in turn, drive our next steps and next direction as it relates to additional content for our microarrays.”

The product line finds its home within Applied Biosystems’ SDS/Other Applied Genomics product category, which in the company’s third financial quarter ending March 31, grew by 29 percent in total revenues over the year-ago quarter, while the firm’s flagship DNA sequencing products fell by 4 percent, compared to the same quarter in 2003.

The company is looking “with enthusiasm” at this line of products for functional genomic analysis, which includes the company’s TaqMan gene-expression assays and the 7900HT microfluidic cards that are now being marketed as TaqMan low-density arrays, Applera CEO Tony White said in the company’s recent conference call with financial analysts.

Meantime, ABI, feeling the pinch of flat growth in its sequencing products, continues an internal review process with an unnamed consulting firm to determine which product line to feed with research and development investment to seed future growth.

While the initial efforts to create a microarray product line were first documented in company records in February 1999, Mason told BioArray News that what was launched in April was the result of a development project covering the past two years and involving a wide team of people from groups including consumables development, manufacturing, operations, software, and communications — in total 170 people who received a company “Thank You” note after the product launched.

While the company has not disclosed the amount it spent on the development of the platform, Mason said that development was a “significant part of the costs” of getting the product to the market.

The product was launched later than anticipated because the comp-any opted to incorporate feedback from test sites into the rollout, the company said.

The product line is financially proceeding as the company planned, said Cannon.

“We have breakeven points and we are working towards [them], and we are on track as it relates to the launch of the product and initial expectations,” said Cannon, who joined ABI earlier this year from Molecular Design Limited, where he was vice president of marketing. Previously, he was senior director of marketing for Incyte Genomics.

The company’s development team crafted the entire platform — the software, the reagents, and the consumable devices, or microarrays. These arrays use an application of chemiluminescence for hybridization detection that is novel in mass-produced microarray analysis tools technology.

The method used in this system of hybridization detection is a biochemical reaction using proprietary dioxetane screening reagents from Tropix of Bedford, Mass., a company acquired by Perkin-Elmer in 1996, and then set up as a wholly owned subsidiary of Applied Biosystems.

At the root of the beige benchtop system, which uses 2-inch by 3-inch microarrays only readable with ABI instrumentation, is a dual method for detecting gene expression in biological samples — which combines the chemiluminescence process with fluorescence. Each probe contains a 60-mer oligo, used in the chemiluminescence process imaged by a CCD camera, and a 24-mer oligo, which is lit up fluorescently by light-emitting diodes to locate each of the 35,000 spots on the array.

The company did not provide BioArray News with any specific patents underlying the platform before Tuesday’s publication deadline.

“We have been working very closely with our legal team and constantly have filed disclosures and patent applications,” Mason said.

The instrument is constructed at ABI’s Singapore facility; the microarrays are assembled in the company’s Foster City, Calif., headquarters facilities using oligos manufactured in the company’s Pleasanton, Calif., facilities. The instruments are shipped to customers from the Foster City facility.

The company offers three reagents for the platform. Each array requires a chemiluminescence kit, and a choice of non-amplification reverse transcriptase labeling, or amplifying reverse transcriptase in vitro transcription, depending on sample requirements.

The processes of generating cDNA or cRNA involve the incorporation of digoxigenin, followed by overnight hybridization to the microarray. After the washing of the cartridge, the process is next followed by the introduction of an anti-digoxigenin, alkaline phosphatase antibody conjugate, a solution that stabilizes and enhances the biochemical light production reaction and produces light, localized to the hybridization, which is then imaged.

The instrument lists for $179,000, with microarrays priced at $625 each but discounted for volume purchases. The product is marketed with a one-year warranty and service contracts that start at $14,000 for basic service, and increase based on level of service, the company said.

The company has two demonstration units in the US, one in Europe, and one in Japan.

The company segments the market for its product into three groups: Those entering the market for the first time; those users who are already using ABI’s DNA systems; and those using home-brew technology.

“[Those] are three customer classes that we have been thinking about,” said Mason.

To reach them, the company has recast the existing microarray technology in an effort to wring out higher sensitivity for detecting lower-expressing genes. It has created a benchtop technology that would fit in with its large installed base of DNA instruments and integrate with its existing gene-expression product line and the Celera databases, and priced it at market value to woo the large mass of the market still utilizing spotting technology.

“We have found an art, a way of getting the performance improved with high sensitivity,” said Mason.

Customer test sites conducted an experimental protocol for the company and feedback was measured on ease of use, sensitivity, reproducibility, and overall biological relevance, said Cannon.

“By and large, they met or exceeded our expectation,” he said.

Time, and publications, will likely tell whether this next-generation product, so long in the birthing, will live up to the pedigree of its parent, or find a sweet spot in the moving target of this market, and the larger trend of integrative biology, which is just starting to roll through the life sciences research market.

That future view, said Mason, might unspool on ABI’s map viewer software, which, in response to a researcher’s keystrokes requesting information on a gene, provides an animated view of exons, introns, and other data derived from the company’s tools, as well as public databases.

“It’s a good format to keep collating that information from disparate parts of our technologies and present it to the customer in an intelligible way, so they can know exactly what they are measuring in the lab,” Mason said.

That link to Celera’s data may be the distinctive value-add of ABI’s sales proposition.

“All targets are matched to corresponding TaqMan probes based on real-time PCR assays,” said Cannon. “This essentially validates the hits that are found in whole-genome arrays, so it adds the biological specificity that users don’t have today.”

So now, the product is on the market after a process that wound to a finish with weekly meetings with ABI President Mike Hunkapiller; Executive Vice President Cathy Burzik, the leader of ABI’s internal review process, as well as the commercialization team.

“We have essentially for the last three months had what we call business action team meetings to make sure we maintain our pace and delivery according to our dates that we set in advance,” said Cannon.

Meantime, the company was prepping its sales and service groups for the rollout with a training program called the “March Readiness Program,” to provide platform experts in eight of the company’s territories.

“When people see the product launch, they think we are just being done with the project and got the performance done,” said Mason. “Actually, the performance and the system were sorted out a long time before that. What you are doing between then and when you launch the product is getting your organization trained, and getting it in place.”

“We are allowing researchers to start with the entire genome and complete the validation to their target gene sets, utilizing the gold standard in TaqMan, and downstream sequencing platforms. And we can even go in the other direction: Upstream we also provide sample preparation and nucleic acid separation and isolation. So it is a whole solution rather than a point solution.”

—MOK

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