CombiMatrix s New Dx Unit In Talks With Potential Distributors, Customers

NEW YORK, July 12 (GenomeWeb News) - CombiMatrix Molecular Diagnostics, a newly created subsidiary of CombiMatrix, has begun negotiating with undisclosed potential distributors and customers, the company said today.

As GenomeWeb News reported in May, the wholly owned business was created to focus on microarray-based diagnostics. Specifically, the business aims to be a testing center for clinicians who wish to use CombiMatrix' array technology for certain molecular diagnostics applications.

CombiMatrix said it hopes the subsidiary can 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.

The unit will initially focus on developing cancer diagnostics using the CombiMatrix's Desk Top Synthesizer, which was designed to enable researchers to build their own chips, Bret Undem, vice president of research at the Mulkiteo, Wash.-based CombiMatrix, said in May.

The unit has "begun efforts to build our first cancer diagnostic products based on CombiMatrix's CustomArray technology," Matthew Watson, CMD CEO, said in a statement today. He added that CMD has applied for "all appropriate licenses," including its Clinical Laboratory Improvement Amendment certification, which would enable its homebrew business. "We have also begun strategic alliance discussions with potential distributors and customers," Watson said.

Additional details were not disclosed.