By Ben Butkus
Caliper this week made its first major foray into the molecular diagnostics space by partnering with Korea's Seegene to analyze PCR products from Seegene's multiplex molecular diagnostic assays using Caliper's newly launched LabChip Dx.
For Caliper, the moves open up a new market for its LabChip Gx nucleic acid separation platform, which the company on Tuesday repositioned as the LabChip Dx with the intent of selling it primarily to customers at clinical research laboratories developing molecular diagnostics.
In addition, the LabChip Dx launch and Seegene partnership are the first in a series of actions by Caliper intended to help it further penetrate the molecular diagnostics market and even submit its own molecular diagnostics regulatory filings by next year, Caliper CEO Kevin Hrusovsky said this week.
For Seegene, the partnership stands to help expand the market for its SeePlex multiplex endpoint-PCR-based diagnostic assays, the company said.
Under the partnership between Caliper and Seegene, announced yesterday, Seegene will market and distribute its SeePlex assays outside of the US for use with Caliper's LabChip Dx. The companies said that they would co-market the products "effective immediately" and work together to expand the number of diagnostic tests available and commercialize certain of those assays.
In preliminary fourth-quarter 2010 revenues announced this week, Caliper said that Seegene has ordered 17 LabChip Dx systems, valued at more than $500,000, which will be shipped over the next three months to customers in six countries.
SeePlex is Seegene's multiplex endpoint PCR technology that uses the company's proprietary DPO, or dual priming oligonucleotide, technology to enable simultaneous multi-pathogen detection.
Seegene currently offers several molecular assays under the SeePlex brand, including CE-IVD marked tests for influenza A ACE subtyping, influenza A/B detection, and multiple diarrhea-causing viral agents.
The company also has its own instrumentation for nucleic acid extraction, multiplex PCR, and electrophoretic detection and analysis; and its tests are compatible with a variety of similar instruments from companies such as Shimadzu, Applied Biosystems, and Lab901.
However, Caliper's LabChip Dx, which uses microfluidics for chip-based electrophoretic analysis, may enable a more multiplexed, rapid, and inexpensive method for users to analyze PCR products from SeePlex tests.
"Our unique SeePlex technology enables highly multiplexed PCR directly from clinical samples," Seegene founder and CEO Jong-Yoon Chun said in a statement. "When coupled with Caliper's microfluidics-based electrophoretic LabChip platforms, the SeePlex assays enable new paradigms for a variety of analytes in a fully automated and highly cost-effective manner."
A Seegene spokesperson added in an e-mail to PCR Insider that the agreement with Caliper was also about "getting Seegene’s assays more firmly entrenched in the market, especially considering the large number of instruments Caliper has installed on the market."
Caliper's LabChip Dx is basically a rebranding of its LabChip Gx nucleic acid separation platform for the molecular diagnostics market, the company said.
The system enables simultaneous analysis of up to 10 different analytes in a single sample using minimal sample volume; avoids the need to further purify or dilute diagnostic PCR products; and features specific identification, scoring, and reporting software, according to Caliper.
Caliper introduced LabChip Gx in 2008 primarily for the biomedical research markets. However, Caliper's Hrusovsky told PCR Insider this week that the company became aware last year that customers were exploring the Gx for diagnostic development applications, particularly those that called for a high level of multiplexing.
"I believe we actually placed [around] 15 Gxs in 2010, and most of those were in the second half," Hrusovsky said. The company also forged strategic molecular diagnostic development relationships with companies such as Access Genetics and Transgenomic; "and we sold quite a few to [Bio-Reference Laboratories]," he added.
Caliper also became aware that Seegene was performing many of its endpoint multiplex molecular diagnostic assays on the LabChip Gx.
"[Seegene] provides reagent sets that are very unique, and very nice panels for many different diseases," Hrusovsky said. "We decided … that if we add what we're doing [to] what they're doing, we can … make a big impact in molecular diagnostics in this area of multiplexing. So basically we struck a deal with them where they are now going to use LabChip as the preferred platform for worldwide distribution everywhere but the US."
However, the Seegene deal, along with the rebranding of the LabChip Gx as LabChip Dx, only marks the beginning of Caliper's move into the molecular diagnostics market, according to Hrusovsky.
For instance, Caliper plans to invest in additional R&D over the coming months to "improve the economics of our chip so that maybe even more tests run simultaneously," he said.
"Longer term, we have a lot of relationships with big pharma and biotech, and so we are actually going to continue evolving our platforms toward companion diagnostics, as well," Hrusovsky said. "We're in the process of evaluating different disease panels to see where our multiplexing can bring the biggest advantage. And then we're going to look to form additional relationships with big pharma and biotech to further build out some of their companion diagnostics."
As such, Caliper is seeking partners that have an interest in multiplexing their endpoint PCR diagnostic assays; and is hoping to work with those partners, including potentially Seegene, to seek 510(k) approval in the US and CE IVD marking in other countries for specific multiplex diagnostic panels whose PCR products would be analyzed on the LabChip Dx.
"We would actually like to be able to assess some panels to do our own 510(k) submission sometime in 2011," Hrusovsky said. "And we are going to be making our own submission for CE IVD [marking] for the LabChip Dx by next year. So we do think that there are a lot of opportunities there, probably more in 2012, because it will take some time to complete some of those processes."
Longer term, Caliper is hoping to combine this part of its business with multiplex tissue imaging technology it acquired in December along with Cambridge Research and Instrumentation, Hrusovsky added.
"At some point, longer term, we think that platform will also play a role in the companion diagnostic opportunity," he said.
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