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New to PCR Game, Serologicals Will Bolster S&M of Technology Developed at Intergen

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Serologicals, an Atlanta-based blood-products company, intends to put its sales and marketing muscle into its PCR technology Amplifluor.

Amplifluor, which Serologicals took over after acquiring a small research-tool company a little more than a year ago, is a fluorescence energy-transfer reporter system for detecting PCR reactions. Seeing value in it, Serologicals quickly tweaked the technology for genotyping applications.

“Since the acquisition I would say the status of the [Amplifluor] business has become a focal point” in the company,” according to Michelle Greene, a product manager at Serologicals. “We are absolutely committed to developing this product further … including increasing sales and marketing.”

The technology, which has become part of Serological’s biotechnology division, is believed by analysts to generate $1 million in annual revenue for Serologicals. “It’s one of those things that we’ve recognized we have to do to get above the radar,” Greene added.

Amplifluor was originally developed by Intergen, a privately owned company from Purchase, NY, Serologicals acquired for $45 million in December 2001. Serologicals’ entry into the SNP market marks a departure for the company: Before the Intergen acquisition, Serologicals was known primarily as a manufacturer of a wide range of blood products like bovine serum albumin, cell culture media, blood typing reagents, monocloncal antibodies, and immune globulins.

“We looked at the SNP market and we think we found a techno-logy we think will work in today’s SNP market,” Greene said of Amplifluor.

According to Serologicals, Amplifluor, like most other PCR-detecting technologies, uses a stem-loop DNA structure with a fluorophore on one end and a quencher on the other. But rather than having the hybridization sequence in the loop, Amplifluor uses a 3’ primer at the end of the sequence that serves as a PCR primer.

The company took that 3’ primer and made a universal sequence — one that can prime any PCR reaction that is initially primed with allele-specific primers that contain the same universal sequence.

“The system was originally developed with quantitative PCR in mind, but we put a couple of twists to it that really made it a superb tech- nology for people doing genotyping studies,” according to Mike Garrett, a brand manager at Serologicals.

Garrett said having both allele-specific primers in the same tube substantially decreases the risk of allele discrimination. Plus, Amplifluor will likely be less expensive than its competitors, according to Serologicals. While other technologies, like Applied Biosystems’ TaqMan, require two fluorescent probes for each SNP studied, Amplifluor, which can run on any tool that detects two-channel fluorescence, allows researchers to use the same two fluorescent probes for every assay.

Though the Amplifluor technology is little-known and Serologicals is a new kid on the SNP block, Garrett said the technology is decidedly low throughput. “The next wave is going to be putting a lot of [the human-genome] information to good use,” said Garrett. “And, yes, there are going to be people out there who’ll want to do entire haplotype maps … and a million SNPs on a thousand patients. We may not be right for them.

“But when you do have … a pharmaceutical company that wants to apply some pharmacogenetic element to their clinical trial and they’re going to want to invest several to tens to maybe hundreds of SNPs in a certain patient population, then they really need flexibility,” Garrett said. “Our technology will fit nicely into that.”

In the mean time, Serologicals may first have to overcome internal financial obstacles. During the fourth quarter last year the company “restructured” its R&D organization in Scotland and the US “to better align research and development investments with [its] strategic direction,” Serologicals said in a statement last month.

In addition, the firm has “restructured” the management of its protein-fractionation facilities, and is in the process of “restructuring” its commercial operations “to further increase the focus on its strategic growth areas.”

Company officials declined to define ‘restructuring’ in both cases. However, analysts reckon Serologicals is girding to “de-emphasize R&D spending.”

— KL

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