NEW YORK – Oxford Gene Technology on Monday announced that eight of its CytoCell fluorescence in situ hybridization probes have been certified for clinical use in line with Europe's In Vitro Diagnostics Regulation (IVDR).
According to the Oxford, UK-based company, the probes are important for patient management while treating hematological cancers and prenatal conditions. OGT is a wholly owned subsidiary of the Kobe, Japan-based Sysmex Group.
Europe's new IVDR began to apply last May, replacing its IVD Directive, which had been in force since 1998. Under the new regulation, most molecular tests require certification by a notified body, a designated standards organization. OGT said that it began discussions with BSI, its notified body, in 2019, leading to the certification of the first eight FISH probes under the new regulation.
CEO Adrian Smith said in a statement that gaining IVDR certification is a "challenging process," and said that obtaining the certificates is a "testament to the clinical efficacy and safety" of OGT's products.
According to OGT, the probes were certified as Class C devices under the IVDR. The probes are expected to launch soon, the company added. The company also said that more of its products will be certified but did not specify which ones.
OGT gained US Food and Drug Administration clearance for eight probes for use in detecting chromosomal rearrangements in acute myeloid leukemia and myelodysplastic syndromes in 2019.