In the 35 years since the birth of the first child conceived via in vitro fertilisation (IVF), the field has advanced significantly and the technique is now widely accepted and frequently used.
But all areas of medicine may be improved, and a new screening process called Eeva may help doctors select the embryos with the best chance of developing into a healthy baby. Lissa Goldenstein, president and CEO of Eeva’s developer Auxogyn, says: “The idea behind Eeva was to determine non-invasive markers, ways that you could look at an embryo’s development, and predict which ones are more likely to be viable.”
Having a blastocyst
In a face-to-face interview at the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in London, Ms Goldenstein tells EP Vantage that the Eeva test eliminates some of the subjectivity when it comes to embryo selection.
Traditionally, embryos are observed under a high-intensity microscope to determine their stage of development, Ms Goldenstein says. “Embryologists have to visually grade embryos, and they have to do it pretty quickly because the embryos are out in the open and under a hot light – typically the embryologist will try to review a dish of embryos in five minutes or less.”
The Eeva system monitors the development of embryos by filming them as they grow inside the incubator, allowing them to remain at a constant temperature as they do not have to be removed.
“Taking video images in itself isn’t really novel, but what we found that there were specific timing windows, and if the embryos developed along that path in those specific windows, those were the embryos that were most likely going to grow to become a healthy blastocyst,” Ms Goldenstein says.
A blastocyst is an embryo made up of 70-100 cells. This stage is usually reached on the fifth day after conception, and most fertility clinics wait until an embryo becomes a blastocyst before implanting it into the mother.
Eeva, which stands for early embryo viability assessment, can pre-empt this stage, predicting on day three which embryos will become healthy blastocysts on day five. “You have the best of both worlds: you can transfer on day three but you should have the same success rate as if you had waited to day five to transfer.”
It is designed to be used as an adjunct to traditional visual assessment by embryologists, Ms Goldenstein says. “They’ll grade all the embryos first using morphology and then they’ll get the Eeva score, which gives a high or low probability [of viability], and they’ll use Eeva to deselect embryos. Eeva’s really strong on specificity. When Eeva says [an embryo] is not viable, it’s three times more correct than the human eye.”
The test is already on the market in Europe, where Ms Goldenstein says it has been doing well. “We got our CE mark in July last year and our first clinics were installed in August or September and we’ve treated over 800 patients in the UK and Ireland.”
The cost of Eeva in the UK is around £800 ($1,200) per round of IVF, which can cost around £5,000 per cycle if performed in a private clinc. With the success rate of IVF standing at just 25%, many couples would be happy to pay the extra £800 to boost their chances.
Born in the USA
Auxogyn is in the process of obtaining US registration for Eeva via the unusual de novo pathway – an encouraging sign as it means that the FDA has stated that there is no predicate, signalling that the device offers something new.
The de novo path was created to speed approval of lower-risk devices, but Auxogyn – the company’s name is pronounced to sound like oxygen – does not have a precise idea of when Eeva will reach the US.
That said, the US market is not as crucial for IVF products as it is for other devices. Fertility treatment is much more expensive in the US than it is in Europe and many other areas, and uptake is relatively low. The Chinese market is growing the fastest, Ms Goldenstein says, and ought to overtake Europe as the biggest sector in the next few years.
Keeping options open
If the future of Eeva is planned out, the future of Auxogyn is less prescribed. The company has completed two funding rounds, raising a total of $38m courtesy of traditional VCs TPG Biotech and Kleiner Perkins Caufield and Byers, as well as Merck Serono Ventures and SR One, the venture wing of GlaxoSmithKline.
The company also has a research alliance with Merck Serono, but Ms Goldenstein says that this is not the first step to an acquisition. “It was not a strategic investment. Their venture group is very separate from their business units – in fact in the first year the Chinese wall was so thick it was hard to even meet people on the fertility side of the business.”
She adds: “The good news is that if an acquisition was the direction we went in, there are a lot of different companies that would be interested, not just one or two. Anyone in the prenatal field, anyone in women’s health… there are a lot of people on the periphery of women’s health interested in the IVF market.”
But a buyout is not the only option. “We get investment bankers saying ‘you’re the kind of company that could do an IPO’. We run the company as standalone and I think we have the opportunity to do that, but you always keep your options open.”
Interest in Auxogyn – from bankers and others – will grow as the patients treated so far in UK and Ireland start seeing their pregnancies carried to term. The first baby screened with the test in Scotland has already been born. Her name? Eva.
|Auxogyn: Venture Financing Rounds - by Date|
|Financing Date||Financing Round||Investment ($m)||Investor Name||Source|
|June 5, 2012||Series B||18.0||Kleiner Perkins Caufield and Byers||Source|
|Merck Serono Ventures|
|February 2, 2012||Series A||20.0||Kleiner Perkins Caufield and Byers||Source|
|Merck Serono Ventures|
All data sourced to EvaluateMedTech