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CMD Adds Melanoma Dx to Pipeline as It Anticipates February CLIA Approval

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Combimatrix Molecular Diagnostics has partnered with researchers at the University of California, Los Angeles, to create a diagnostic for malignant melanoma using CombiMatrix microarray technology, the company said last week.

The test is the second to be trotted out by the Newport Beach, Calif.-based company this month, and suggests that the firm, founded by CombiMatrix last May, is maturing (see BAN 5/11/2005). CMD hopes to begin offering the test for clinical applications in the summer of 2006. It hopes to offer its flu test for clinical applications in February when it anticipates obtaining CLIA certification.

According to a statement from CMD and UCLA, "the test is aimed at helping pathologists discriminate between atypical pigmented moles and malignant melanoma."

The UCLA group will work with CMD using routinely prepared formalin-fixed paraffin-embedded material, UCLA said. The team, led by Scott Binder at the Department of Pathology and Laboratory Medicine at the Geffen School of Medicine, will also provide clinically validated patient samples for the validation phase of the project.

Matthew Watson, CMD's CEO, told BioArray News this week that the company chose melanoma because it was an area in need of better testing.

"The thing that was attractive about melanoma, as with some of the other tests we are focusing on, is these are areas of clinical testing where today there aren't really great solutions clinically," Watson said.

"The methods to discriminate between benign moles and malignant melanoma are fairly crude, to be honest," he said. "We feel that a gene-based test for melanoma would be a much more accurate way to discriminate between those two conditions."

Although the test is the second CMD has announced, it will be the first actually developed by the company. Watson said that the first test, a DNA-based microarray service to identify types of influenza, including the H5N1 bird flu, as well as mutations and novel strains of flu not yet seen, was a "kind of a bonus."

"That was developed by CMD's parent [CombiMatrix]," he said. "Since we have a clinical laboratory, it's a nice opportunity to make it available to researchers and that sort of thing, but the first clinical [area] we're really focused on and hopefully releasing sometime midsummer '06 is a test for melanoma."

According to CMD, the flu test can be run both on animal and human samples, and is available now with a research-use-only label until CMD receives federal approval to operate as a lab under the Clinical Laboratory Improvement Amendments. The melanoma test is expected to follow this path.

CMD isn't the only party that sees promise in influenza testing. Nanogen this week released two analyte-specific reagents for the detection of respiratory viral pathogens, a product for differentiating among influenza A and B, respiratory syncytial virus, and parainfluenza 1, 2, and 3, as well as an ASR for influenza A and B viruses (see People & Products).

In a statement, Nanogen CEO Howard Birndorf gushed that "the market for respiratory virus testing is estimated to be over $100 million annually." "With the shipment of these new products, Nanogen is making a strong play to grab a piece of that market," he said.

As for CMD's foray into flu testing, "we expect it to be available as [a] homebrew [test] at the end of February," Watson said. "We anticipate getting our CLIA license by the end of February [and] at that time the test could be offered as a homebrew test -- then basically you can bill insurance companies and that sort of thing," he said.

"We've built our core scientific team, gotten our lab up and running. The next milestone for us is to get our CLIA certification," Watson said. In addition, he said CMD is expecting more growth as it is cleared for testing and launching the flu and melanoma tests.

CMD currently employs 15 staffers in a 3,000-square-foot R&D lab, and Watson said CMD "anticipates throughout 2006 adding a fair number of staff as we expand the number of projects we are working on."

"Obviously as we go into clinical mode" the company will likely expand," he said. "Then we'll have to gear up for that, and that's going to include facility expansion, adding employees, et cetera."

-- Justin Petrone ([email protected])

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