The Bloom Thyroid test received the approval certificate from the Notified Body, which will allow lay-users to perform the test at home. Previously, the product had already been approved for professional use. The Bloom Thyroid Test is designed to screen for hypothyroidism in individuals 18 years of age and older. The user is required to take a pin-prick blood sample that is captured in the Bloom Test strip and deployed into the Bloom Lab device. Cloud-based algorithms then aggregate test results with other measurable health status indicators alongside medical history, lifestyle, and individual symptoms, giving rapid, fully encrypted feedback through a personalised report on the Bloom App. The entire smart testing process takes around 10 minutes.
The Bloom Thyroid Test asks the user to input information on whether they are taking medications, such as Lithium or Amiodarone, as these are known to have an impact on thyroid function. The smart test also considers if women are pregnant, have given birth in the past 12 months, or if they plan on conceiving in the near future. This is due to thyroid hormone production increases during gestation, making TSH tests during pregnancy often unreliable.
Thyroid-stimulating hormone, also known as TSH, is the main regulator of the thyroid function and stimulates the release of thyroid hormone secretion. Several factors can influence TSH levels and they are known to vary during the day due to their natural circadian rhythm. Elements such as exposure to extreme temperatures, stress, exercise, and fasting may also influence TSH levels. In the case of hypothyroidism, if the thyroid is underactive and produces too few hormones, TSH levels increase to stimulate the thyroid to produce more.
The results are provided by the Bloom System in a report which includes information on the needs of users based on their circumstances, including special advice for women that are planning pregnancy, insights about the most typical hypothyroidism symptoms, and risk factors. In addition, for those with elevated TSH levels, the report observes potential influencing factors and facts about treatments.
According to the European Society of Endocrinology, thyroid disease is among the most common endocrine disorders, affecting millions of patients throughout Europe. Research by NCBI revealed that hypothyroidism is caused by a failure of the thyroid gland to produce thyroid hormones in 99% of cases. The Mayo Clinic a non-profit American academic medical centre focused on integrated health care, education, and research states that hypothyroidism may not cause noticeable symptoms in the early stages but if left untreated, the condition can lead to several health problems, such as obesity, joint pain, infertility, and heart disease.
Angelica Kohlmann, MD PhD, co-founder and chairperson at Bloom Diagnostics, said: “The Bloom System aims at impacting the healthcare market by making smart testing accessible to consumers and professionals in a range of sectors. The newly approved Bloom Thyroid Test provides a great opportunity to generate personalised recommendations and health advice to millions of users suffering from hypothyroidism. This is one of many rapid at-home tests to become available, bringing Bloom Diagnostics one step closer to making healthcare accessible for all.”