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EraGen to Develop Multiplex MDx Tests on Applied BioCode Platform

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EraGen Biosciences and Applied BioCode said this week that they have entered into a strategic partnership and license agreement to develop and commercialize highly multiplexed molecular diagnostic tests.

Under the agreement, EraGen receives access to Applied BioCode's barcoded magnetic bead technology and CE-Marked BioCode-1000 system, which EraGen will couple with its MultiCode-PLx assays for analyzing nucleic acid targets in infectious disease and genetic testing for clinical laboratories, the companies said.

EraGen's MultiCode-PLx assays work by amplifying target nucleic acids, then hybridizing the amplified DNA to target-specific extension primers that contain MultiCode sequence tags, called EraCodes. These sequence tags incorporate isoC and isoG, probe-free bases that are structurally similar but not complementary to naturally occurring bases, and instead are specific to each other.

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.

MultiCode-PLx assays are ideally paired with high-throughput, multiplexed, bead-based detection systems. In its early days, EraGen forged a partnership to pair the assays with Luminex's bead-based detection systems.

However, that partnership did not pan out, and more recently EraGen has begun seeking other vendors with which to commercialize MultiCode-PLx assays. In November 2009 it struck a deal with Illumina to develop molecular diagnostics using MultiCode-PLx assays on Illumina's BeadXpress platform.

And last May, the company said that it was also considering Santa Fe Springs, Calif.-based Applied BioCode as a formal business partner after the companies presented data demonstrating how their technologies could be paired to detect respiratory viruses in a multiplex fashion (PCR Insider, 5/27/10).

This week, EraGen and Applied BioCode made it official.

"We are very pleased to partner with EraGen in such an important and valuable segment of the molecular diagnostics market," Winston Ho, president of Applied BioCode, said in a statement. "The combination of EraGen's patented chemistry with our barcoded magnetic beads and BioCode-1000 system will provide a powerful testing platform for clinical laboratories."

Applied BioCode's barcoded magnetic beads are formed by doping biocompatible polymer with paramagnetic material. They permit probes and specific primers to covalently bind to the bead surface, thus enabling the attachment of proteins, peptides, nucleic acids, and other ligands in a highly multiplexed format. The beads allow anywhere from one to 128 tests to be performed in a single microwell of a standard 96-well plate.

Meantime, the BioCode-1000 is an optical imaging system for the 96-well microplate format. After undergoing reaction, the barcoded magnetic beads settle to the bottom of each well, allowing for barcode identification and fluorescent signal detection. The entire system can thus perform between one and 128 target tests for 96 samples in one hour.

Applied BioCode received CE certification for the BioCode-1000 system in May 2010.

"We look forward to commercializing molecular diagnostics that address not only customers needing real-time molecular testing, but also those in the growing segment that need highly multiplexed in vitro diagnostics," EraGen chairman and CEO Irene Hrusovsky said in a statement. "Our relationship with Applied BioCode will help us reach those goals."

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