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With Array CGH Test Launch One Month Away, CMDX Says It Welcomes Discussion With FDA

Responding to an untitled letter sent by the US Food and Drug Administration in June, CombiMatrix Molecular Diagnostics last week said it welcomes the opportunity to discuss its technology with the agency as it plans to begin selling its first Constitutional Genetic Array Test next month as a homebrew diagnostic.
CMDX CEO Matthew Watson told BioArray News that the company had been “planning on contacting [the FDA] anyway, so this is a great opportunity for us to get this done.”
In fact, he said, the FDA may have meant to send the letter to CMDX parent CombiMatrix because both units have similar names.
“We don’t really plan to sell it here in the US [for clinical use] without FDA approval,” he said. “Obviously, the rules on that are pretty darn clear. I think there has been some confusion because our parent corporation is a manufacturer and that might have created some confusion with the agency.”
Watson said that a meeting has been tentatively scheduled for mid- to late-September with the agency’s Office of In Vitro Diagnostic Device Evaluation and Safety, around the same time that CMDX plans to begin selling the CGA test, a bacterial artificial chromosome-based comparative genomic hybridization product that the firm claims can genetically identify more than 50 common genetic disorders, including developmental disorders.
CMDX’s CGA test has been available for research purposes in Europe since April through the firm’s distributor Array Genomics, and Watson signaled last week that the company will likely pursue FDA clearance to sell the test for clinical use in the US in the future.
“Primarily this product will be sold as a testing service run in our CLIA laboratory as a homebrew test,” Watson said. He declined to say when the company would submit the test with the FDA but explained that the firm has a number of tests in the pipeline and that the CGA test was “high on the list” of contenders for FDA submission.
If CMDX pursues FDA clearance for the CGA test, it will be the first time the FDA will consider a BAC-based microarray diagnostic. Such a review would come at a time when there are relatively few others on the market or in development.
“Ultimately, we do intend to bring some of [our] products through the formal approval channels at FDA to sell to the clinical market in the US. This is a great opportunity for us to begin that dialogue,” Watson said.
OIVD’s untitled June 21 letter concerned CMDX’s CGA test specifically, but Watson said last week that the firm’s parent CombiMatrix is also looking to capitalize on the opportunity to introduce OIVD to its technology.

“I think there has been some confusion because our parent corporation is a manufacturer and that might have created some confusion with the agency.”

Though the CGA test is printed on a platform developed at CMDX, which is independent of CombiMatrix’s oligo-based array technology, CMDX said it plans to use Combi’s platform in the future.
In fact, Watson said that the agency might have gotten the two similarly named and abbreviated firms confused when it approached them in June.
Watson said that CMBX CEO Amit Kumar will sit in on the meeting in September. “We are excited about the opportunity to sit down with them and explain the platform and the differences between the BAC arrays, oligo arrays, and how we intend to apply those clinically,” Watson said. Kumar said that the only thing he could say was that CMBX was trying to schedule its meeting with the FDA. OIVD Director Steven Gutman last week declined to comment on the issue.
FDA’s Interest in Molecular Dx Continues to Grow
The FDA’s letter to CMDX was untitled, though the agency has sent warning letters in the past to array manufacturers when it believed the companies were improperly marketing technologies for clinical use. Most recently, OIVD last August sent a letter to Nanogen concerning the firm’s Molecular Biology Workstation (see BAN 8/24/2005).
According to OIVD, materials on Nanogen's website described the firm's Molecular Biology Workstation, NanoChip microarrays, and analyte-specific reagents as clinical diagnostics tools. Gutman declined to comment on discussions with Nanogen.
Gutman also declined to discuss FDA’s talks with CMDX, except to say that the “FDA is interested in understanding new technology and assuring new products comport with FDA regulatory requirements.”
Last week Watson said that he believes that the FDA is becoming more interested in the emerging generation of molecular diagnostics, in general.
“I get a sense that they are becoming more interested in multiplexed nucleic acid testing in general, particularly microarray platforms. I think the agency wants to understand the platform and the technology better, and I think that’s a good thing,” he said.

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