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)1 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, Kateřina 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.“ Kateřina is currently a member of the Steering Committee of the ESHRE PGD Consortium and is the Chair of the Accreditation Working Group. She 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.”
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
1. Yang et al; Journal of Molecular CytoGenetics 2012. 5:25
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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BlueGnome microarrays are for research use only.
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For further information please contact:
Dr. Sally Cartwright
Marketing Manager
Sally.Cartwright@cambridgebluegnome.
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