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Sigma Life Science to Roll out First Pre-Designed qPCR Products Later This Year

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Sigma Life Science, a division of Sigma Aldrich, is attempting to increase its share of the qPCR market by introducing for the first time pre-designed qPCR products to complement the custom product design work that has comprised the core of its business for the past several years.

As part of the rollout, SLS will launch its first pre-designed products — forward and reverse qPCR primer pairs for all human, mouse, and rat genes — in the late summer or early fall of this year, company officials said.

In addition, SLS plans to bolster its custom product offerings by upgrading its qPCR assay-design software so that it covers the entire gamut of qPCR probe types currently offered by the company, the officials said.

Sigma-Aldrich has been a major player in the life science laboratory products space since its earliest days, but its focus on the molecular biology space intensified in the 1990s and 2000s with a spate of product introductions and acquisitions in the areas of nucleic acid amplification, sequencing, and gene expression.

Notable acquisitions during this time included Genosys Biotechnologies, a supplier of custom synthetic oligonucleotides and peptides, in 1998; and Proligo Group, a genomics research tools firm, in 2005.

Those acquisitions became part of Sigma-Aldrich's SLS group, which today offers a wide range of life science research products in areas such as cell culture, cell-based assays, gene knockdown and transfection, proteomics and peptides, and nucleic acid purification and amplification.

SLS has evolved its qPCR business by licensing key technologies and applying internal know-how so that it can offer its customers — which include researchers in academia, pharma, and applied markets — the widest array of qPCR chemistries possible for their gene expression research, Tom Russell, global product manager for commercial/OEM, molecular diagnostics, and qPCR probes at SLS, told PCR Insider in a recent interview.

"Starting with SYBR Green qPCR … those are just primers, so no IP is necessary," Russell said. "We can make either custom primers or pre-designed primers to customer specifications, and … if there is any licensing needed … the customer is responsible for acquiring that."

"In terms of probe types that we sell, we have four types: dual-labeled probes, molecular beacons, [Qiagen's] Scorpions probe, and [Roche] LightCycler probes," Russell added. "All of those are under IP, which we have licensed from the appropriate entities, which allows us to manufacture and distribute those globally. The same thing goes for all of the various modifications that we offer, such as locked nucleic acid for thermal stability; or the various reporters and quenchers, as well."

Russell added that the SLS group has not focused on developing its own qPCR technologies internally; rather, "most of our internal R&D is based on what we call technology development … where we're trying to optimize and improve the manufacturing process to essentially squeeze more efficiency out of it, [with] greater capabilities [and a] broader range of scales and purifications. In terms of the technologies that customers are most familiar with, usually we end up licensing most of that."

SLS has traditionally only offered custom designed primers to its customers. "The researcher provides a sequence and we manufacture to their particular specifications," Russell said.

"However, over the past year we are trying to transition more to pre-designed products," he added. "It's just shifts that we've seen in the markets. A lot of customers, especially academic customers, are pressed for time and money and resources. And anything you can do to speed up their research and make life easier for them [adds] value."

The first major pre-designed products that SLS will offer, sometime in the "August-to-October" timeframe, Russell said, are what it calls KiCqStart Primers for two-step and one-step SYBR Green I qPCR; along with KiCqStart SYBR Green ReadyMix master mixes.

Customers will be able to go to SLS's website to search for and select any of three ranked sets of forward and reverse primer pairs for all human, mouse, and rat genes using the latest NCBI RefSeq, according to the company.

This is not a "new-to-the-world" product, Russell noted, but it is new to SLS. And, the company believes it can "shake up the market" with extremely competitive pricing for its qPCR primers.

"These products have been around from certain competitors out there," Russell said. "I think what's going to be unique about this is it will be an extremely economical product in terms of the absolute price and the price per reaction. You're going to get a far better price and number of reactions than you're going to get with some of the competitors out there."

Russell said that SLS could not disclose exact pricing for its pre-designed primer pairs at this time. However, he noted that the list price of most pre-designed SYBR Green forward and reverse primers is commonly more than $80. Comparatively, the typical list price for custom primers, where the customer provides sequences of interest, would be less than $15, he said.

"If you look at what's on the market right now, some of these pre-designed primer pairs for SYBR Green qPCR are outrageously expensive," Russell said. "Just from talking to customers … it's shocking how many of them can't afford to buy them. And then you talk to them, what if you could buy them for this much, with this many reactions, and their eyes light up. So there is some unlocked potential there that's not available. In my opinion, a lot of researchers who cannot or will not purchase this type of product at current price points will be drawn in after KiCqStart launches."

When asked about the potential risk that the new pre-designed primers may eat into SLS's current custom primer design business, Russell noted that the company views the two approaches as serving different markets.

"Usually with the pre-designs, it's reference genomes — so human, mouse, rat, Arabidopsis, and so on," Russell said. "Those are where customers are usually doing high-throughput screening; it's a well-characterized and annotated gene, and they just want to click it online, order it, measure their gene expression, and go. The custom business is a little different. Usually these are customers working with other species, where the pre-designs don't really make sense for them."

Despite the new market focus, SLS will continue to improve its custom qPCR design offerings this year, primarily by launching the latest version of its online qPCR assay design software, called OligoArchitect, which the company launched previous iterations of in February and October of last year.

SLS will release version 3 of OligoArchitect "probably in July or August … and we'll probably update and enhance the tool once per year [thereafter]," he said.

Version 3 will feature online design capabilities for all of the probe types that SLS currently offers. "Right now, it's only useful for dual-labeled probes: 5' nuclease assays and SYBR Green qPCR," Russell said. "With this version, people will also be able to do designs for molecular beacons, Scorpion probes, and LightCycler probes. So essentially, the whole portfolio of products that we offer in the qPCR probe space will be available online for people to do designs in real time. To my knowledge, that's something that no other competitor currently offers."

Currently, he added, several companies offer qPCR design software, "but they tend to be very limited. So the algorithm was developed in house, and as a researcher, you don't know who designed it or the quality of it. And the other thing is, these tools generally don't have a design module for all of the probe types that these competitors offer."

In addition to its custom design and forthcoming pre-designed qPCR offerings, a third major part of SLS' qPCR business is commercial OEM. "That's where we're making oligos for customers' products, and in turn, they sell those to their customers, so our oligos are sort of making up the guts of their products," Russell said. "That's a significant area of focus for us, and then we're also starting to get into the [molecular diagnostics] space, but again, not making the end products, just making the components for those various assays."

Russell said that he couldn't disclose any of SLS's OEM customers due to confidentiality agreements.

According to a an online overview of Sigma-Aldrich, its research products account for approximately 71 percent of the company's revenues, while Sigma-Aldrich Fine Chemicals accounts for about 29 percent. Sigma-Aldrich reported sales of $2.5 billion in 2011.

Although the company does not officially break out individual product revenues for its SLS business, officials said that in the genomics space, nucleic acid purification accounts for approximately 30 percent to 32 percent of revenues, followed by PCR and nucleic acid analysis, such that the two segments taken together account for approximately half of its genomics products revenue.

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