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Time-lapse IVF embryo imaging tool cleared by FDA

16 June 2014

By Dr Molly Godfrey

Appeared in BioNews 758

The US Food and Drug Administration has approved a time-lapse imaging tool designed to improve the embryo selection in IVF for use in the USA.

The Early Embryo Viability Assessment, or 'Eeva', developed by Auxogyn, uses proprietary software to image the development of embryos in the laboratory. The company says this information can help doctors to determine which ones are most likely to be viable.

A clinical trial showed that using Eeva along with morphology techniques meant that the odds of an embryo reaching blastocyst stage were 2.57 times greater than those not predicted to reach blastocyst stage, around five to six days. The company said the results showed a 53 percent increase in odds ratio over traditional morphology techniques alone.

Dr Michael Glassner, one of the doctors running the trial and division head of infertility at Bryn Mawr Hospital, Pennsylvania, said: '[Eeva] is helpful beyond words. It's going to give more clarity to the patient. It's going to give a higher pregnancy rate. The miscarriage rate goes down. It's just going to change the field'.

The method behind the test was developed by researchers at Stanford University in 2010. It relies on imaging the first few cell divisions of developing embryos and timing how long these take to happen, with the time between each cell division being a good prediction of embryo viability. Auxogyn acquired a license to develop products based on this method shortly after the work was published, and patented the technique in 2012.

The method was approved for use in the EU in 2012 and is also licensed for use in Canada. Auxogyn plans to commercialise the test in the USA later this year. 'We're excited to receive the de novo FDA clearance for the Eeva System and believe this marks a significant milestone in the field of IVF', said Lissa Goldenstein, CEO of Auxogyn.

'At Auxogyn, we are committed to improving the IVF journey for couples and giving them a better chance of a successful outcome'.

Auxogyn (press release) | 10 June 2014
Chicago Tribune | 10 June 2014
Yahoo! News | 10 June 2014
Bloomberg | 10 June 2014


12 June 2017 - by Cara Foley 
Fetuses in the late stages of pregnancy move their heads towards shapes that resemble faces, suggesting that the ability to recognise faces may be innate...
15 May 2017 - by Dr Marianne Kennedy 
The first batch of baby brain scans was released last week by a landmark UK project to map how the human brain develops in unprecedented detail...
27 October 2014 - by Dr Linda Wijlaars 
An IVF method using an in-body incubator is safe and effective, research presented at the American Society for Reproductive Medicine annual meeting shows...

08 July 2013 - by Siobhan Chan 
A 'powerful' form of genome analysis could improve embryo selection for IVF, according to scientists who report that the first baby has been born from this method...
03 June 2013 - by BioNews 
A patent over a method for assessing cell-cycle data that can be used in IVF treatments to predict an embryo's future viability will make IVF treatments in the USA prohibitively expensive, a leading embryologist has said...
20 May 2013 - by Emma Stoye 
A technique for monitoring embryo health could increase the chance of IVF couples having a healthy baby, according to a study from researchers at a private fertility clinic...
11 October 2010 - by Dr Lux Fatimathas 
US researchers have developed a means to predict which human embryos produced through IVF are most likely to result in healthy births. Researchers filmed 242 one-cell embryos and predicted, with more than 93 percent accuracy, those that would survive up to five days. These findings may improve the success rate of IVF....

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