Precision Medicine Advances in Hormone Therapy: Lund University’s FSHR Genotype-Guided Innovation

Overview

A groundbreaking oral swab test developed at Lund University offers a significant advancement in precision medicine for assisted reproductive technologies. By targeting the FSHR N680S genotype, this test enables tailored gonadotropin therapy, demonstrating a 38% increase in live birth rates when hormone therapy matches the patient’s genetic profile, translating to 110 additional babies per 1,000 women treated.

Here is  a concise example illustrating how the technology changes clinical treatment:

For example, a patient with the NN genotype (homozygous for the N allele at position 680 of the FSHR gene) would be prescribed recombinant FSH, which has been shown to significantly improve ovarian response and live birth rates in this subgroup. In contrast, patients carrying the S allele (NS or SS genotypes) respond better to urinary FSH, enabling clinicians to tailor gonadotropin selection based on genetic compatibility rather than a one-size-fits-all approach.

This demonstrates the shift from empirical to genetically guided ovarian stimulation. Let me know if you’d like this phrased more simply or adapted for a patient-facing audience.

Clinical Implementation

The test provides results within one hour, allowing immediate application within the same IVF cycle. This swift turnaround enables seamless integration into routine IVF protocols. The method improves outcomes and is cost-effective by reducing failed cycles and unnecessary hormone exposure. The potential impact is substantial, with 1 million IVF cycles annually in Europe.

Scientific and Technical Foundation

The test is based on robust randomized controlled trial (RCT) evidence involving 1,466 women. It demonstrated that:

• S-carriers (of the N680S polymorphism) benefit from urinary FSH.
• NN genotype patients respond better to recombinant FSH.

These findings are grounded in cellular studies on ovarian granulosa cell function and receptor activity, supporting the FSHR N680S genotype as a functional biomarker for gonadotropin responsiveness.

Diagnostic Innovation

The diagnostic platform uses a , a pink/yellow readout detectable with only a standard water bath heater. This low-tech requirement and rapid results make the system highly adaptable and globally scalable. The technology is also expandable to other genetic targets, opening doors for broader personalized reproductive care.

Clinical Outcomes

• 38% improvement in pregnancy and live birth rates (OR 1.55, p<0.001).
• 51% pregnancy rate in the genotyped group vs. the standard protocol.
• This translates to four additional school classes worth of children per 1,000 women treated.

Commercial Development

The innovation is being commercialized by Dx4Life AB, which recently raised 6.4 million SEK to support its market launch planned for early 2026. Backed by Lund University’s innovation ecosystem, including , the company is positioned for rapid clinical rollout.

Implications for Clinical Practice

This technology is ideally suited for inclusion in IVF clinic protocols, offering a scientifically validated, clinically practical, and economically viable solution for improving ART outcomes. It represents a pivotal advancement in personalized hormone therapy, with global implications.

References

1. Hjelmér I, Nilsson M, Henic E, Jędrzejczak P, Nenonen H, Ozegowska K, Giwercman A, Laczna Kitlinski M, Lundberg Giwercman Y. FSH receptor N680S genotype-guided gonadotropin choice increases cumulative pregnancy and live birth rates after in vitro fertilization. Front Endocrinol (Lausanne). 2025;16:1576090. doi:10.3389/fendo.2025.1576090. PMID: 40433406; PMCID: PMC12106330.
2. Lindgren I, Bååth M, Uvebrant K, et al. Combined assessment of polymorphisms in the LHCGR and FSHR genes predict chance of pregnancy after in vitro fertilization. Hum Reprod. 2016;31(3):672-683. DOI: 10.1093/humrep/dev342
3. Higher success rate using a simple oral swab test before IVF. Published May 13, 2025. Available from: https://www.sciencedaily.com/releases/2025/05/250513112451.htm
4. Medicon Village. Dx4Life secures funding ahead of launch of its groundbreaking rapid test for IVF treatments. Published December 18, 2024. Available from: https://www.mediconvillage.se/dx4life-secures-funding-ahead-of-launch-of-its-groundbreaking-rapid-test-for-ivf-treatments/
5. Progress Educational Trust. Genetic test indicates best hormone treatment for IVF. Published May 2025. Available from: https://www.progress.org.uk/genetic-test-indicates-best-hormone-treatment-for-ivf/