ARTPred is a biotech company that develops tests that could save countless women the burden of unnecessary IVF treatment. Recently, ARTPred was granted a sum of €250.000 by Technology Foundation STW. Startupjuncture interviewed COO and co-founder Jonathan de Jonge, about creating synergy between science and business.
First of all, could you explain what ARTPred does?
ARTPred is a biotechnology company founded in January 2014, with its core business in artificial reproductive technology. IVF (in-vitro fertilisation) is one of the techniques that can be used for women who can’t get pregnant in a natural way. Multiple egg cells are maturated by hormone hyperstimulation, an egg cell is extracted from a woman, fertilized inside a lab before being inserted into the woman’s uterus. For a pregnancy to start, the developing embryo needs to implant in the inner layer of the uterus. However, only three out of ten attempts are successful after the first IVF cycle and result in pregnancy. Meanwhile, the burden is high for the women under treatment, physically as well as emotionally. They get hormone treatment which can be unpleasant, the egg cells need to be retrieved and, after fertilization, transferred into the uterus, and they have to wait in uncertainty. If we know with almost 100% certainty that embryo implantation will fail, these women could be saved the unpleasant procedure and emotional stress. Based on tests measuring the bacterial composition in urine or in vaginal swabs, we can make this prediction very accurately.
How do the tests work?
ARTPred is cooperating with two research alliances that, independently of each other, made similar breakthrough discoveries. The first alliance consists of researchers from the Erasmus Medical Center, from the departments of Urology and of Gynaecology. They studied different sorts of bacteria in urine, together called the microbiome, by DNA analyses. What they found is, that the proportion of four sorts of bacteria in urine was different for women who got pregnant versus women who didn’t get pregnant during IVF treatment. Their explanation is that these bacteria prefer the same conditions in the human body as the embryo does in the uterus, thereby giving a signal that the conditions in the uterus are right for embryo implantation to occur. Based on this finding, they composed a formula to predict failure of embryo implantation. The accuracy of the formula was tested in a first cohort of IVF-patients and, interestingly, they found that the prediction can be made with 96% certainty. You can compare it to a PIN code: by knowing four pieces of information you ‘can get access to the system’. So, with a limited amount of information, a very accurate prediction can be made. The urine test is patented by the Erasmus MC and exclusively licensed to ARTPred.
And what about the other breakthrough discovery?
The other discovery was made by researchers from the Vrije Universiteit Amsterdam together with researchers from a spin-off company from this university called Microbiome. Two of the scientists involved in this project are Prof. Dr. Servaas Morré and Prof. Dr. Paul Savelkoul. They found that embryo implantation failure can be predicted by studying bacteria from vaginal swabs. Instead of just looking at different sorts of bacteria, they look at classes, which are groups of similar bacteria. Compare it to a football team: if one player is bad, it might not be a huge problem for the whole team, but if many of them are bad, then probably they will not win many matches. Similarly, if one sort of bacteria in a class is missing, the conditions might be fine for embryo implantation, but if many of the sorts of bacteria in a class are missing, not. The analyses are also done on DNA. This test gives more specific information than the urine test, you can compare it to a fingerprint versus a PIN code. Although it will take some extra effort to perform the test. The vaginal swab test is patented by Microbiome, and exclusively licensed to ARTPred.
Fascinating, these scientific discoveries. What kind of role does ARTPred have?
ARTPred holds the licences of the patents of the urine and vaginal swab tests and is dedicated to make these tests available for all IVF patients worldwide. We are working to launch the tests onto the market. To achieve that, more research has to be done. Both the urine and the vaginal swab test are validated based on research in small groups of women. However, we need to validate the tests in larger groups, to be more certain that these methods really work. Currently, ARTPred is coordinating research in a group of 300 women in the Netherlands. Several IVF centres are involved. Subsequently, we will continue with an even larger group of women in Europe, and after that with a group of women in the United States. ARTPred is also involved in certification of the tests. We are working to obtain a CE marking, which is a ‘quality stamp’ for products sold within the European Economic Area. To be able to sell in the United States, we need to obtain a certificate from the FDA (Food and Drugs Administration, the federal agency responsible for the regulation and supervision of food and drugs). In addition, we have other activities that keep us busy: we are working with different stakeholders, are building our team, are obtaining sufficient funding and are working to refine our business case.
Did you talk to health care providers in IVF clinics, or women who are going there, to determine if there is a need for the tests?
Yes, we talked for example to representatives of Freya, the Dutch patient association for people with fertility problems. We were a little apprehensive that they wouldn’t be enthusiastic about tests that might take away hope from women who have deep feelings of wanting to have a child. The opposite was true: they were very positive. They told us that it is hard to imagine how difficult it is for women to endure the whole procedure of IVF treatment. And that it would be good to save women this procedure if it is certainly not going to be successful. Also embryologists and gynaecologists working at IVF centres reacted positively. In a way, this enables them to provide better care, because the success rate of IVF treatments for woman with a good bacterial composition will increase. Instead of two-star hotels, it will make the centres four-star hotels, so to speak. As expected, health insurance companies reacted positively, because these tests will lower costs drastically and will enable ‘tailored care’ for women undergoing IVF treatment.
It sounds as if the market is ready for the launch of the tests.
What I see is that many biotech companies have a push strategy: they say that although their product will increase the costs, it makes the situation much better. We have a combined push and pull strategy: there is a great need for these tests and they could cut down expenses for healthcare. Nowadays, many IVF centres have to economize. They can decide to offer less IVF treatments or lower the amount of hormone that the women get during hormone treatment. These measures result in a decrease in the number of pregnancies. With our tests, the number of pregnancies will not change and up to 40% of the costs could be saved. However, before we reach this stage, we need to wait for the results of the large validation studies. Luckily, even in the worst case scenario that the results are not positive for one of the two tests, we still have the other one.
ARTPred has been awarded many grants, for example by STW and the Netherlands Genomics Institute. Do you have advice for people who are applying for grants with this kind of institutes?
All in all, ARTPred raised sufficient funding for 2014 and 2015 thanks to the NGI Preseed grant, The RedMedTech loan and the loan from the government foundation for scientific research STW. It is quite difficult to give advice that is relevant for many people, because every case is unique. I think it is very important to start in time with creating the right conditions and building a strong team. You have to have the right people in place. This also means building connections with scientists. Of course, a biotech company needs to have a good invention, but this is not enough. If you think of the invention like a rough diamond, you need the right people to cut the facets. For example, the expertise of ARTPred’s CEO Joep de Mönnink is complementary to my expertise. He has a strong network in the field of IVF treatment and is experienced in commercialization and market access and my expertise lies in business development, in turning ideas into a successful business. It’s all about the right combination of people in the team. People with a passion for what they do.
You have been working in the biotechnology sector for a while. What do you think of doing business in this sector?
I think this is the most stimulating sector there is. I keep in contact with the smartest inventors, the true pioneers in their field. After they make a discovery, there are still many hurdles to bring it to the market. The different stakeholders make my function filled with interaction. It is adrenaline-inducing, which really corresponds to what I like. My personal motivation to work for ARTPRed is to ensure that these tests will reach the people who will benefit from them, the women who wish to get pregnant. In this way, I hope to create a better world. That said, I think some things can be improved in this sector. Quite often after a discovery has been made and patented, it isn’t immediately brought to the market. No action is taken until the patents get too expensive and then the project is shot down for financial reasons. That is such a shame.
What are ARTPred’s plans for the near future?
We expect to be able to launch the products into the Dutch market in 2016. Apart from the predictive use, we are investigating the possibilities for therapeutic use. These tests might be used to assess the effects of treatments aimed at increasing the chance of embryo implantation. I also think that women who are trying to get pregnant in a natural way might benefit from the tests. So, many things to come.
|IVF treatment: a few facts
In the Netherlands, each year between 16.000 and 18.000 IVF treatments take place. A treatment costs about 3.000 euros. The annual cost in the Netherlands is approximately 48 million euros. It is estimated that 2.610 women per year are excluded from unsuccessful IVF treatment by the urine and vaginal swab tests. This results in a reduction in cost of 12 million euros per year.
Image credit: Nuno Ibra