FISH Probes Approved for Targeted Genome Analysis in Cancer

Oxford Gene Technology (OGT) recently announced that the US Food and Drug Administration (FDA) has granted de novo classification for eight Cytocell Aquarius® Haematology fluorescence in situ hybridisation (FISH) probes for myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML). The cleared FISH probes allow for easy detection of chromosomal rearrangements reported in both MDS and AML. We spoke with Steve Chatters, Director of Medical Affairs at OGT, to learn more about the application of FISH probes in modern medicine. 

Molly Campbell (MC): Can you tell us about the research concept and development behind the FISH probes? 
Steve Chatters (SC): These probes are designed to allow accurate analysis of a number of different chromosomal rearrangements seen in AML and MDS. They were submitted to the FDA together, as OGT recognise that laboratory testing strategies may require the use of one, or more, of these probes within the laboratory work-up for patients referred for confirmed or suspected AML or MDS.

MC: Currently, how widely used are FISH technologies in molecular medicine? 
SC: FISH is used as an adjunctive technique within diagnostic medicine and has been adopted in the majority of genetic/cytogenetic testing laboratories worldwide. It falls between the microscope-based technique of G-band cytogenetics and more recent molecular techniques such as microarray and next generation sequencing. Which areas/specialities are they most commonly adopted in? FISH testing is mostly used within haematology and oncology diagnostic work-ups. 

MC: How do the FISH probe test kits compare to the current diagnostic tools used in AML/ MDS?
SC: These probe kits have undergone rigorous clinical and performance testing as part of the FDA de novo process and are the most complete set of AML/MDS FISH probes cleared for use by the FDA.

MC: Using the FISH probe test kits, how quickly can the chromosomal rearrangements in patients be detected?
SC: These probe kits will give a result as quickly as the day after testing has been initiated, as they have an overnight hybridisation step. 

MC: OGT is quoted as saying that “FISH technology is a long-term diagnostic solution” in the press release. Do you expect there to be significant advances in the research in the near future?
SC: FISH analysis is a robust, quick, easy and cost-effective solution for targeted genome analysis. New technologies are being developed by Sysmex to automate the analytical process, combine this with flow cytometry techniques and dramatically increase the number of cells that can be assessed in a short time from a single sample. Forward-thinking initiatives such as this will further increase the accuracy and effectiveness of FISH testing and will open-up the technique to novel clinical applications.   

Steve Chatters was speaking to Molly Campbell, Science Writer for Technology Networks.