The first IVDR-certified Cytocell FISH probes are here!

By Tram Nguyen

Introducing the IVDR-Certified FISH Probes 

Regulation (EU) 2017/746 (IVDR) is a new regulatory framework for IVD medical devices. It sets higher standards for quality and safety for in vitro diagnostic medical devices to ensure the highest level of public health protection. All CytoCell® IVD FISH probes are affected by the IVDR and must be compliant by May 2026. Probes used for Research Use Only (RUO) are unaffected. Critically, clinical labs will be required to use an IVDR-certified probe if one is available on the market by this date. OGT will continue to pursue additional certification for the CytoCell FISH probe portfolio. 

Why choose OGT’s CytoCell probes? 

In 1991, OGT became the first provider of FISH probes in the world. Over 30 years later, OGT is the first to market with its In Vitro Diagnostic Regulation (IVDR) certified FISH Probes essential for managing hematological malignancies and aneuploidy testing! IVDR is a priority for OGT as it ensures safe, reliable, and effective products for you and your patients. 

Quality and confidence 
IVDR certification demonstrates OGT’s continued commitment to provide safe, reliable and effective products. 

OGT’s experienced Field Applications Scientists are dedicated to supporting you to optimise products, on-site or remotely. 

No revalidation needed 
IVDR Cytocell probes are the same robust, reliable designs, so existing users do not have to revalidate, saving you time in the lab. 

Clinical expertise 
OGT has more than 100 years of clinical experience within the company, helping to develop FISH probes that are IVDR compliant 

Top solid tumour FISH probes

HER2 (ERBB2) Amplification Probe

Areas of interest: Breast cancer
Region: HER2 (ERBB2), 17q12, Red. D17Z1, 17p11.1-q11.1, Green

ALK Breakapart Probe

Areas of interest: Lung cancer
Region: ALK, 2p23.2-p23.1, Red. ALK, 2p23.2-p23.1, Green

Top haematology FISH probes

Del(5q) Plus Tri-Colour Deletion Probe

Areas of interest: AML, MDS
Region: TERT, 5p15.3, Aqua. EGR1, 5q31.2, Green. CSF1R, 5q32-33.1, Red

CBFB Breakapart Probe

Areas of interest: AML
Region: CBFB, 16q22, Red. CBFB, 16q22, Green

Top cytogenetics and rare disease FISH probes

FAST FISH Prenatal X, Y, 13, 18 and 21

Areas of interest: Constitutional
Region: X centromere Xp11.1-q11.1, Green. Y centromere Yp11.1-q11.1, Orange. 18 centromere 18p11.1-q11.1, Blue.


Areas of interest: Constitutional
Region: SRY, Yp11.31, Red. DYZ1, Yq12, Green. DXZ1, Xp11.1-q11.1, Blue

Miguel Larguinho, PhD

Diagnostics, Biotech&Pharma

+46 (0)8 588 931 29

Miguel Larguinho, PhD