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EraGen Again Moving Multiplex Assays Toward Clinic in Wake of Luminex Separation

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By Ben Butkus

Eragen Biosciences is once again eyeing the in vitro diagnostics market for its multiplex PCR assay reagents following the dissolution last year of a longstanding relationship with Luminex, whose bead-based detection systems served as the original instrument platform for EraGen's assay panels.

Instead, EraGen is now in the process of vetting its assay panels on bead-based detection systems manufactured by companies such as Illumina and Applied Biocode, both of which EraGen feels confident enough about to resume a "fast-forward, pedal-to-the-metal move" of its multiplex assays "into full-scale commercialization," EraGen CEO Irene Hrusovsky told PCR Insider this week.

"We are focused on systematically advancing these products through the clinical trial and regulatory submission process," Hrusovsky said. "In terms of getting them through the [US Food and Drug Administration] and into the market, they are under development. They need adaptation to the platforms and then to be put through the paces."

The products to which Hrusovsky referred are part of EraGen's MultiCode-PLx assay kits for multiplexed analysis of nucleic acid targets. These assay kits take advantage of what EraGen calls an "expanded genetic alphabet" that incorporates its isoC and isoG bases into the PCR reaction.

According to EraGen's website, isoC and isoG are probe-free bases that are structurally similar to but do not pair with naturally occurring bases, and instead are specific to each other. The MultiCode-PLx assays involve multiplexed amplification of target DNA or reverse-transcribed target RNA, followed by hybridization of amplified DNA to target-specific extension primers that contain MultiCode sequence tags, which the company calls EraCodes.

If hybridization occurs, the target-specific extensions can be extended and labeled by the PCR polymerase; then captured by specific hybridization using only the EraCode tags, since they use the isoC and isoG bases instead of just the two found naturally in DNA.

EraGen actually does have commercial products under the name MultiCode-RTx, which also use the isoC and isoG bases for highly specific, real-time, but non-multiplexed, PCR assays that can be run on a number of real-time PCR instruments.

EraGen sells MultiCode-RTx assay kits as analyte-specific reagents and research-use-only reagents, although one of the assays, a test for herpes simplex I and II viruses, earlier this month received 510(k) clearance from the FDA, making it the first molecular IVD to detect and type HSV 1 and 2 in symptomatic women.

But as multiplex real-time PCR assays gain more and more traction as potentially inexpensive and time-saving IVDs, EraGen is looking to push its MultiCode-PLx assays to market.

"We have a lot of products developed using both these technologies, and now it's a matter of prioritizing and managing allocation of resources to advance these swiftly to the regulatory process," Hrusovsky said.

EraGen was well on its way toward doing just that through a partnership with Luminex that started as early as 2003 and was formally announced in 2005. Under that agreement, EraGen obtained the rights to distribute and sell its multiplex assay kits along with Luminex's bead-based readers for certain IVD applications.

But in 2007, when Luminex acquired Tm Bioscience for its multiplexed assay content, EraGen was able to "see the writing on the wall," Hrusovsky said.

"That was a strategic decision on their part to move away from an open platform business model to … having their own content, at least in the areas that Tm Biosciences embraced, which was genetic testing and respiratory virus testing," Hrusovsky said.

"[Tm Bioscience] was a little more advanced than us operationally — they had a 510(k) — but basically we were head-to-head competitors in terms of the menu," she added. "And basically when Luminex decided to buy them, Eragen obviously saw that … our partner was now our competitor, and we aggressively pursued alternative platforms to Luminex."

Hrusovsky said the agreement with Luminex was officially terminated last year. In an e-mail to PCR Insider, Russell Bradley, Luminex’s vice president of business development and strategic planning, confirmed that the licensing agreement with EraGen is no longer in place, but declined to provide additional details.

Evidence of the former partnership still abounds. Hrusovsky said that EraGen has one undisclosed customer who licensed products under the EraGen-Luminex partnership; and this month researchers from Washington University School of Medicine published research begun a few years ago demonstrating that EraGen's-PLx Multi-Code respiratory virus panel — run on the Luminex 100 instrument — outperformed both conventional virologic testing methods and laboratory-developed PCR assays for detecting a variety of infectious agents (see related story, this issue).

The lead author of that study and an early collaborator on the development of the respiratory virus panel, Washington University researcher Gregory Storch, told PCR Insider that his lab was "very, very impressed with the assay," but that it is currently "in sort of a state of limbo, trying to find a different platform."

To be sure, EraGen has moved on to alternative platforms. In November, it announced a strategic partnership and licensing agreement with Illumina that will give EraGen access to the BeadXpress platform to develop and commercialize high-throughput, multiplexed molecular clinical assays using the MultiCode-PLx technology. Meantime, Illumina has a license to the MultiCode-PLx technology for life sciences, research, and clinical applications.

"When the process of commercialization on one platform moves on to alternative platforms, it becomes a little challenging to manage as a small company," Hrusovsky said. "That said, the fantastic part about MultiCode-PLx is that it is all about the chemistry. Anything and everything we originally developed on the Luminex platform, which includes this product and a number of genetic applications, is portable to another detection system like BeadXpress and others."

Another platform that EraGen is considering is the BioCode-1000 Analyzer with barcoded magnetic bead technology, manufactured by Los Angeles-area firm Applied Biocode.

Hrusovsky declined to provide additional details about this partnership, but said that EraGen and Applied BioCode presented an abstract about pairing their technology for detecting respiratory viruses at April's Pan American Society for Clinical Virology symposium in Daytona Beach, Fla.

Given its history with Luminex, Eragen may also "keep an eye toward" other platforms that may be suitable for EraGen's tests, but "we feel very good about the potential of Illumina as a strong partner, and about the prospects with Applied Biocode, as well," Hrusovsky said.

Illumina's BeadXpress platform is particularly attractive to EraGen now that it has received 510(k) clearance, earlier this month, for an undisclosed clinical assay as well as its VeraCode genotyping test for Factor V mutation (Leiden) and Factor II mutation (prothrombin).

"The BeadXpress system is a very attractive alternative, perhaps a better product overall than Luminex, so we're excited about that," Hrusovsky said.

It is unclear which clinical applications EraGen and Illumina will target first for their combined technologies, but the respiratory viral panel is one of EraGen's most mature MultiCode-PLx technologies, Hrusovsky said.

"We're looking at it," she said. "Given that the test is already developed, it really is now a matter of qualifying it fully; validating and verifying it on the new platform; and progressing the platform to the FDA. Those timelines are being worked on now."

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