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FDA Wants to Talk With CombiMatrix About Its Constitutional Genetic Array Test

NEW YORK (GenomeWeb News) – CombiMatrix said today that the US Food and Drug Administration's Office of In Vitro Diagnostic Device Evaluation and Safety has asked to speak with it about its Constitutional Genetic Array Test.
 
CombiMatrix said the FDA wants to "discuss" the company's "plans to market [the] CGAT in September." CombiMatrix said that it plans to meet with the FDA in the “near future.”
 
Last month CombiMatrix Molecular Diagnostics said it will launch its first molecular diagnostic service in the US in August. The service will use the CGAT, which “can genetically identify more than 50 common genetic disorders,” including developmental disorders. The service is already sold in Europe through Paris-based Array Genomics.
 
CMDX said it's in the "final phases" of internal human and clinical validation. In March, CMDX and Array Genomics said they will co-develop and co-market a series of comparative genomic hybridization microarrays for diagnosing genetic anomalies associated with mental retardation, a developmental disorder.
 

Matt Watson, CEO of CMDX, said in June that the firm is "actively developing further tests based on both our oligo and BAC capabilities that augment our microarray portfolio and over the next three quarters, we have plans to launch three to five additional products into the molecular diagnostics market."

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