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Biosearch Seeks to Enter IVD Market with Expanded Roche License

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Biosearch Technologies has taken an important step toward entering the in vitro diagnostics market by expanding its license with Roche Molecular Systems in the area of nucleic acid amplification technologies, the company said this week.

Under the new license, Novato, Calif.-based Biosearch now has the right to manufacture and sell validated kits to the IVD marketplace as licensed products covered by multiple patents assigned to Roche.

The company said that these kits will comprise probes, primers, enzymes, and any other essential reagents necessary to amplify and detect diagnostic targets.

Biosearch's original licensing agreement with Roche, signed in September 2009, covered practice of the 5' nuclease process, and allowed Biosearch to manufacture dual-labeled 5' nuclease probes to conduct in-house research; to catalog related probes and primers; and to provide them to Roche-licensed CLIA labs providing molecular diagnostic assays. The new license, on the other hand, relates to TaqMan probes and their use in IVD markets.

"With this expanded Roche license, Biosearch is poised to enter the IVD marketplace as a pivotal manufacturer of diagnostic kits," Marc Beal, director of corporate development at Biosearch, said in a statement.

Financial terms of the licensing agreements with Roche have not been disclosed.

It is unclear which segments of the IVD market Biosearch will tackle, though it appears the company is best positioned to manufacture IVD kits for influenza: In November, Biosearch licensed from the US Centers for Disease Control and Prevention novel H1N1 influenza signatures along with influenza A sub-typing panel signatures.

The license conferred to Biosearch rights under the CDC patents to manufacture and sell oligonucleotides bearing the H1N1 and influenza A sub-typing signatures.

It also appears that Biosearch plans to incorporate its own proprietary dye technologies into its IVD kits. The company said that as inventor and patent holder of the Black Hole Quencher, CAL Fluor, and Quasar dye technologies, it is the sole source offering access to the dyes for research applications; and is the only company able to synthesize them into probes for incorporation into kits for diagnostic or commercial purposes.

Biosearch added that the series of BHQ dyes have become "an essential component in the highest performing, frequently demanded qPCR assays in the IVD market, including the original 2009 H1N1 influenza assays purchased by public health and other qualified laboratories worldwide."

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