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CombiMatrix Forms Molecular Dx Unit to Perform Home-Brew Tests; Eyes Eventual FDA Clearance

NEW YORK, May 10 (GenomeWeb News) - CombiMatrix has created a molecular diagnostics subsidiary, its parent company, Acacia Research, said today.

 

The wholly owned subsidiary, named CombiMatrix Molecular Diagnostics, will focus on microarray-based diagnostics. Specifically, CMD will serve as a testing center for clinicians that wish to use CombiMatrix' array technology for certain molecular diagnostics applications, the company said.

 

The unit will initially focus on developing cancer diagnostics using the company's Desk Top Synthesizer, which enables researchers to build their own chips, according to Bret Undem, vice president of research at the Mulkiteo, Wash.-based company.

 

Company officials told BioArray News, a GenomeWeb News publication, that by setting up the diagnostics shop, CombiMatrix planned to take advantage of US Food and Drug Administration guidelines that allow the use of homebrew microarrays in creating diagnostics, thereby generating revenue before its technology gets FDA approval. Under the FDA's home-brew rules, labs that make the diagnostic array in their facilities and test it there do not require FDA approval.

 

Undem said CMD will initially be a five-man operation based out of Irvine, Calif.It will be used to demonstrate the viability of CombiMatrix' products in molecular diagnostics, and to act as a specialized lab for clinicians who cannot get similar tests done by other third parties.

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