The US Food and Drug Administration (FDA) has cleared Applied Spectral Imaging's (ASI) GenASIs automated scanning and image analysis system.
The GenASIs 7 will detect and analyse chromosome 17 and the HER-2/neu gene through fluorescence in situ hybridisation (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens.
Intended for in-vitro diagnostic use as an adjunctive automated enumeration tool, the GenASIs Scan and Analysis system will aid in the detection of amplifications of the HER-2/neu gene in human breast cancer specimens.
ASI CEO Limor Shiposh said the company has received an additional and important FDA clearance.
"We plan to expand our portfolio of FDA cleared tools in our GenASIs platform to better serve our customers in achieving more accurate clinical results, quicker and more cost-effectively," Shiposh added.
Using the new system, ASI will now provide three major FDA cleared tests, which include an aiding tool in breast cancer - HER2/neu FISH, CEP XY used to assess effectiveness of bone marrow transplantation in opposite-sex transplants, and UroVysion for detection of cells in urine specimens from persons suspected of having bladder cancer.
ASI said its manual and automated scanning platform and image analysis systems are expected to provide reliable HER2/neu FISH test results quickly and cost-effectively.
The GenASIs automated imaging platforms for genetic and pathological analysis offer diagnostic aids for cytogeneticists and pathologists analysis, and enable automated tissue analysis for primary diagnostics, with reproducible results.