Earlier this month Dx4Life reached a milestone in fertility diagnostics, when completing a pivotal clinical trial at Reproduktionsmedicinskt Centrum (RMC). With 100 participants it will provide results on the new product’s performance – compared to classical methods.

The start-up company, founded by Professor Yvonne Lundberg Giwercman, has developed a novel rapid genetic test that enables a more personalized approach to hormone treatment prior to in-vitro fertilization (IVF), to ultimately improve the chances of having a live born baby.

“It is fantastic to see Dx4Life as the first company to emerge from our ReproUnion Innovation Platform, and the collaboration with RMC is a strong example of the translational research that ReproUnion fosters to bridge the gap between laboratory discoveries and clinical application,” says Kristine Koppelhus, ReproUnion Project Director.

From Early Discovery to Clinical Validation

ReproUnion first supported Yvonne’s research at Lund University in 2016-17, where she supervised Ida Lindgren in the initial postdoctoral study: Stratified treatment in ovarian hyper stimulation. The study revealed that a woman’s genetic makeup affects her responses to the hormone treatment used during IVF and thereby affects the IVF success rate. One finding was that only 10% of women with a specific genetic profile (asparagine in two genes) became pregnant, compared to a 40% success rate in women with a different genetic makeup. However, in this study, all women were treated with synthetic hormone. Yvonne therefore undertook a second study, in which half of the participants were treated with biological hormone and the other half with synthetic, as had been done previously.

“Building on the groundbreaking insight that the genotype matters, I got inspired to develop a genetic test to help IVF clinics tailor hormone treatments based on a woman’s genetic profile. I therefore developed the test based on the discovery that genetic variations impact how women respond to hormone treatments. It is designed for IVF clinics with the aim of being simple to use, with a sample collection with only a mouth swab. It then delivers fast results through a color change, allowing clinicians to see the results with their naked eyes, and subsequently to prescribe hormone treatments with greater precision,” explains Yvonne Lundberg Giwercman.

The Eco-system’s Role in Supporting Innovation

Reflecting on the journey from research towards commercialization, Yvonne acknowledges the support from ReproUnion in helping Dx4Life reach this stage.

“ReproUnion has played a crucial role in making this innovation possible. The support first enabled the early clinical studies that gave me the idea to develop this test, and the collaboration has also been invaluable for establishing contacts and networks, also for the younger members of my research group,” says Yvonne.
While securing CE marking is now a key milestone, Dx4Life is also laying the groundwork for a market launch in 2026, with strong commercialization support from LU Ventures, a partner in ReproUnion – as well as with the SmiLe Venture Hub, with whom ReproUnion collaborates.

2024 ended on a high note for Professor and CEO Yvonne Lundberg Giwercman with Dx4Life moving into SmiLe and at the same time securing 6.4 million SEK in additional funding, with Gobia Enterprises and LU Ventures as main investors. This funding round was crucial for securing patents, achieving ISO certification, and ultimately obtaining CE marking for the test. In a press release Ulrika Ringdahl, CEO of SmiLe Venture Hub said:

“This is a great example of how world-leading research, with the support we provide through SmiLe Venture Hub and funding opportunities, gets the chance to be commercialized and thereby contributes to significantly improved IVF care in the near future. This is something in high demand. It is very exciting to support Yvonne and, in doing so, also all future patients.”