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Two centre clinical study confirms 24sure performance

Helen Goldrein

16 July 2010

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Study answers one of the most pressing questions in assisted reproduction: how can we improve the success rate of IVF treatments in women of advanced maternal age?

Acceptance of BlueGnome’s ground breaking 24sure technology was given a boost today by the publication of results from an independent, two centre, clinical study undertaken by the European Society of Human Reproduction and Embryology.

24sure is used to confirm that the correct number of chromosomes is present in the cells used in the formation of human eggs and embryos. Many scientists believe that cells with the incorrect number of chromosomes, a condition termed aneuploidy, are a major cause of infertility and that the identification of such cells has the potential to significantly improve IVF success rates. Until now however the technical challenge of reliably counting chromosomes in single cells has made it very difficult to rigorously test this hypothesis.

Results from the study by the ESHRE PGS Task Force confirm that 24sure can predict chromosomal abnormalities in 89% of all cases. Moreover the study confirmed that results are available within 12 hours, a timescale which makes this approach suitable for use within a fresh IVF cycle and which meets the very tight regulatory requirements which govern such procedures in many countries.

Presenting the results of the study, Professor Geraedts, past ESHRE chairman and coordinator of the PGS Task Force, said, “With chromosome errors being the predominant cause of non-viability of the embryo, we hope this approach will in future effectively improve results in assisted reproduction.”

Nick Haan, BlueGnome CEO, commented, “We have processed over 200 consented clinical cases in our UK service laboratory and have demonstrated a significant increase in the success of pregnancies within this challenging group of patients. This study is important because it provides a scientific explanation for these results. We are now working with IVF centers in over 15 countries to ensure that 24sure is widely available as we await publication of further studies into its clinical efficacy.”

24sure combines BlueGnome’s own molecular and mathematical technology with SurePlex amplification systems licensed from Rubicon Genomics in order to deliver the first complete solution to investigate aneuploidy in 24 chromosomes in 12 hours.

24sure is available as a complete product solution and also as a service from BlueGnome’s 24sure service centre in Cambridge, UK.

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Date Added: 16 July 2010   Date Updated: 16 July 2010
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