REPROMEDA Achieves ISO 15189 Accreditation for BlueGnome’s 24sure Platform

REPROMEDA and BlueGnome (Brno, Czech Republic and Cambridge, UK) are pleased to announce that REPROMEDA has achieved ISO 15189 accreditation for use of BlueGnome’s 24sure platform for their laboratories in Brno, Czech Republic.

REPROMEDA was founded in 1999 as a facility for reproductive medicine and assisted reproduction and was the first facility in Central and Eastern Europe to sucessfully perform preimplantation genetic diagnosis (PGD) as part of its assisted reproduction service.

24sure, developed by BlueGnome, is a technique for aneuploidy screening of 24 chromosomes from single cells that offers the possibility of selecting a single, normal embryo for transfer. This technique can be used for polar body, cleavage stage and blastocyst biopsy and produces reliable results in under 12 hours, making it ideal for fresh IVF cycles. Yang et al (2012) published the first randomised prospective IVF study of preimplantation chromosome analysis using 24sure demonstrating that selectively implanting euploid embryos significantly increases pregnancy rates in younger patients.

Commenting on this accreditation, REPROMEDA’s Medical Director, Kate?ina Vesela, M.D., Ph.D. said „I am very pleased that our PGD team achieved ISO 15189 accreditation for use on BlueGnome’s microarray platform. We are very proud to be the first team to gain ISO accreditation for the use of microarrays for PGD. This provides our clients with the reassurance that their method of treatment and preimplantation diagnosis is offically accredited and provides a basis for other laboratories for follow.“ Kate?ina is a proponent of laboratory accreditation and a world leading expert on ISO laboratory standards as they apply to PGD and IVF-related laboratories.

Many of the world’s leading fertility centres use 24sure as part of their PGS/PGD programmes. 24sure is well positioned to revolutionise the world of IVF, with recent studies showing dramatic improvements to IVF birth rates and corresponding reductions in miscarriage rate. Nick Haan, CEO of BlueGnome said “This ISO accreditation achieved by REPROMEDA confirms that 24sure is becoming a routine platform for European IVF labs and we expect more labs follow their lead. Subject to further clinical studies, 24sure has the potential to become the defacto standard of care for IVF cycles worldwide.”

About BlueGnome

BlueGnome is a leading provider of genetic solutions for the screening of chromosomal abnormalities in cytogenetics and IVF www.cambridgebluegnome.com www.24suretest.com

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