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Quidel, BioHelix to Co-Develop POC MDx Tests

NEW YORK (GenomeWeb Daily News) – Quidel and BioHelix said today that they have inked an agreement to jointly develop and commercialize in vitro molecular diagnostic tests.

Under the agreement, Quidel will fund and jointly develop with BioHelix assays to rapidly detect infectious pathogens in a non-instrumented, handheld format using BioHelix's isothermal amplification technology.

BioHelix will have primary responsibility for assay development, while Quidel will be responsible for manufacturing, marketing, and selling new products developed under the agreement. Quidel also will have exclusive, worldwide commercialization rights to those products, the companies said.

Financial terms of the agreement were not disclosed.

Quidel, based in San Diego, develops rapid POC diagnostic tests for infectious diseases and reproductive health. Its current portfolio of products aids in the diagnosis of diseases or conditions such as influenza, respiratory syncytial virus, fecal occult blood, strep A, pregnancy, H. pylori, and Chlamydia.

Beverly, Mass.-based BioHelix develops diagnostics and nucleic acid tests based on its isothermal amplification technology. Its IsoAmp instrument-free molecular analyzer comprises its proprietary helicase-dependent amplification technology and a disposable detection device.

In April 2008, BioHelix granted a non-exclusive worldwide license for the helicase-dependent amplification technology to Qiagen, which planned to use the technology with its own Hybrid Capture detection platforms in diagnostic tests for various sexually transmitted diseases.