Firm will submit cytogenetic testing system to FDA using pre-IDE process
High-throughput microarray technology used in cytogenetics research may soon have an FDA-cleared product for use by clinical pathology laboratories.
Array-based comparative genomic hybridization can perform the equivalent of hundreds or even thousands of fluorescence in situ hybridization (FISH) experiments in one array. This technology has become the preferred method for molecular cytogenetics research. Recent advances in the technology are making the system appropriate for use by clinical labs and at least one manufacturer is taking steps to enter this market. (more…)