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Applied Microarrays, InDevR Partner to Offer Custom Array Manufacturing, Instruments, Assays

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Applied Microarrays and InDevR this week announced a new partnership that will pair AMI's contract array manufacturing resources with InDevR's instrumentation and assay development capabilities.

Tempe, Ariz.-based AMI makes multiplexed and lab-on-chip arrays and related assays, and provides a full OEM service. Boulder, Colo.-based InDevR sells miPlex custom arrays as well as two imaging instruments — its fluorescence-based Vidia system and its AmpliPhox colorimetric detection system — as well as associated reagents and protocols.

The combined offerings should appeal to customers using low-density focused microarrays, as well as array-based immunoassays, by providing them an alternative to working with companies that offer high-density arrays or bead-based systems, according to AMI CEO Alastair Malcolm.

For the first customer group, where researchers have developed arrays containing biomarkers of interest after initial discovery work, AMI and InDevR's paired offering provides "lower cost and faster turnaround time than available from the high-density microarray providers," Malcolm told BioArray News.

"For these types of custom arrays our engagements are related to particular customer-defined biomarkers, rather than picking from a library of oligos or antibodies," he added.

As for those interested in producing array-based immunoassays, Malcolm said that AMI and InDevR's protein microarray offering provides a "lower cost entry point than bead assays for customers seeking to multiplex [enzyme-linked immunosorbent] sandwich assays."

Malcolm noted that AMI and InDevR intend to use their own brands going forward, and will co-market their products as part of the non-exclusive agreement. He said that AMI should benefit from its relationship with InDevR by reaching more clients and taking part in more projects.

"As an array contract manufacturer serving the global DNA and protein array markets, AMI will continue to grow our customer base on custom arrays," Malcolm said. "The partnership with InDevR will catalyze the development of new opportunities."

Malcolm co-founded AMI in 2007 when the company acquired the assets of GE Healthcare's CodeLink bioarray unit for an undisclosed sum. Malcolm was vice president of operations within Motorola's Biochip Systems group before it was subsequently sold to Amersham Biosciences in 2002. GE absorbed the CodeLink business when it acquired Amersham two years later. Since its establishment, AMI has used the CodeLink array manufacturing resources to build a successful custom array business, supplying a number of researchers as well as companies with chips, among them InDevR.

Malcolm said that about half of AMI's business today is generated by single-test, lab-on-chip devices, where multiplex arrays are spotted on silicon, glass, and plastic chips in cartridges.

"We see this market segment growing faster than the overall array market, driven by the advantages of rapid point-of-care testing," said Malcolm. Much of this growth, he said, is related to the cost per data point.

"In the range used for useful for diagnostic biosignatures ... it is much less expensive to manufacture arrays with pre-synthesized oligos than with other techniques designed for multi-million probes," said Malcolm. "And next-generation sequencing cannot compete with diagnostic arrays that cost under $10, and sometimes as low as $1 or $2 in microtiter plate format."

He noted that when Motorola started the CodeLink business, it sought to capitalize on the convergence of semiconductors, wireless communications, and biology. "It's [taken] over a decade to realize this vision but there are now many novel approaches being introduced by our customers that benefit from AMI's expertise in this field," Malcolm said.

The other half of AMI's revenues are derived from spotting DNA and protein custom arrays on multi-array slides and 96-well microtiter plates, with a focus on supporting CLIA-compliant laboratory's multiplex tests "that are not quite as critical for time-to-answer." Malcolm noted that this second market is "also growing faster than the general, high-density array market."

Again, he attributed the growth to low cost per data point, which he estimated was about a quarter of the price of current single-plex assays. He noted that CLIA labs can maintain their sample preparation workflows and hardware when moving to arrays printed in 96-well plates, which makes moving to array technology less cumbersome.

Through its new agreement with InDevR, AMI can add low-cost scanners to the mix. The company's colorimetric AmpliPhox system has a list price of $4,850 and allows customers to scan two arrays at a time, while its Vidia scanner, which can image as many as 16 arrays printed on one slide, as well as 96-well plates, has a list price of $39,500.

Malcolm said that the AmpliPhox system offers "great performance at an extremely low cost" and called it "perfect for infectious disease and allergy testing." He pegged Vidia as a way for customers to enter the multiplex assay market, and said that entering the same market segments with a new custom assay on competitors' microarray plate scanners or on a bead-based assay system would likely cost twice as much.

InDevR CEO Kathy Rowlen said that since launching its MiPlex custom array offering a year and a half ago, her company has witnessed the same pace of growth in the market.

"There is really a growing demand for targeted arrays to achieve particular goals," Rowlen told BioArray News.

InDevR had a different path to becoming a custom array provider however. Established in 2003, the company has spent years developing array-based tests for infectious diseases. But demand for such a custom array and assay development service eventually caused InDevR to update its business model.

"Because we have built up assay and instrumentation expertise, we often had people coming to us asking for help with their microarrays," Rowlen said. "An opportunity presented itself, and we took advantage of it."

The company's custom array clients so far have been other companies as well as government agencies. InDevR in February presented a poster at the ASM Biodefense Meeting with investigators from the US Army Medical Research of Infectious Diseases, who have developed an assay for detecting and subtyping Crimean-Congo hemorrhagic fever virus.

Rowlen said that InDevR's background in array design and instrumentation and AMI's expertise in array manufacturing provide "very complementary skill sets" for the new partnership.

"It's almost as if one company is an extension of the other," she said, "and it goes both ways."

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