Bloom Diagnostics’ Smart fertility test gets European approval

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. Bloom Diagnostics is an innovative medtech company that has developed a smart system for a wide range of medical conditions. The Bloom System aims to impact the healthcare market by making smart testing accessible to consumers and professionals in a range of sectors. 

The approved Bloom Ovarian Reserve Test is just 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 to 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 personalized report on the Bloom App after just 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 personalized fertility treatment with a specialist. 

Commenting on the latest announcement, Angelica Kohlmann, 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.”

Bloom Diagnostics was founded in 2018 by Angelica Kohlmann and Thomas Kupper. The company’s product portfolio includes the Covid Antibody Test, Ferritin Test, Ovarian Reserve Test and Thyroid Test.

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.