Swiss medtech company Bloom Diagnostics has received European approval for its Bloom Ovarian Reserve Test, measuring AMH (Anti-Müllerian Hormone) using the Bloom System, at-home or in a professional setting.
The approval means that women in Europe will be able to test for this fertility marker and receive real-time feedback at the comfort of their own homes. It follows the recent approval of Bloom’s specialised Ferritin and Thyroid Tests.
The Bloom System aims at providing users access to a range of at-home and self-tests, thereby relieving pressure on GPs and healthcare systems already under strain due to the COVID-19 pandemic.
The approved Bloom Ovarian Reserve Test is one of a growing number of health tests becoming available for the Bloom System.
The single-use self-testing kit for quantitative in-vitro diagnostic examination of the Anti-Müllerian Hormone is designed for women 18-39 years. Pin-prick blood samples are captured in the Bloom Test strip, which is then deployed into the Bloom Lab. Cloud-based algorithms aggregate test results with other information about health status indicators alongside medical history, lifestyle, and individual symptoms. Fully encrypted feedback is delivered through a personalised report on the Bloom App after just 20 minutes. 20 minutes.
Low AMH levels can be an indication of Diminished Ovarian Reserve (DOR) and Premature Ovarian Insufficiency (POI), while high levels of AMH are commonly observed in women with Polycystic Ovarian Syndrome (PCOS) and can be a risk factor for Ovarian Hyperstimulation Syndrome (OHHS), potentially a life-threatening complication during to hormonal treatment during IVF.
When using the Bloom System to test AMH levels, the Bloom App provides results and a detailed report. Knowing AMH levels support treatments and insights on egg quantity, which is why the use is recommended for women who are planning to become pregnant or looking to start a personalised fertility treatment with a specialist.
Bloom Diagnostics was founded in 2018 by Dr. Angelica Kohlmann and Thomas Kupper. In 2020 and 2021 the company closed funding rounds to further strengthen R&D and to drive expansion throughout Europe. Among Bloom Diagnostics’ early investors are Speedinvest from Austria and the Canadian Walter Group. Bloom Diagnostics is ISO 13485 and ISO 9001 certified. Bloom Diagnostics aims to rapidly add meaningful new features to its capabilities to accelerate the pace of clinical discoveries and, ultimately, the development of new therapies.
The 2019 AMH as the primary marker for fertility Report from the European Journal of Endocrinology found that anti-Müllerian hormone (AMH) has taken an increasingly important place in the management of female fertility. These reports further indicate the importance of Bloom’s Ovarian Reserve Test as well as the value of tracking your health.
Angelica Kohlmann, MD PhD, co-founder and chairperson at Bloom Diagnostics, said: “This is a game-changing step for home testing and for women. There is nothing of this nature on the market at present and with the addition of the Bloom Ovarian Reserve Test to the Bloom System, women all over the world can now track their egg count with real-time results from the comfort of their homes. This is something we welcome during what continues to be a turbulent time for global health care services.”
