Kalium Health launches clinical trial of world’s first blood potassium rapid self-test
Kalium Health is recruiting patients into a pioneering clinical study of the world’s first blood potassium rapid self-test - and the first results are expected this month.
The University of Cambridge spin-out, which is backed by Kidney Research UK, will engage about 100 UK kidney patients to evaluate the performance and usability of its handheld test.
This will be compared to traditional, costly hospital-based instruments currently used, which are restricted to professional use.
If successful, the company will seek regulatory approval and to go to market with its technology.
Prof Fiona Karet, chief medical officer at Kalium Health, said: “This clinical study is a major moment for us and marks a further derisking of the business as we continue commercialisation. With patient recruitment now under way, we will have interim results within the coming weeks.
“This study will provide us with valuable data to enable us to build an even stronger case for adoption, given the significant cost savings, efficiencies and improved patient outcomes our technology can offer.”
Since spinning out of the University of Cambridge with seed funding in 2020, Kalium Health has developed an integrated hardware/software platform that provides a rapid, quantitative readout from a tiny drop of blood.
Its initial focus is on the accurate monitoring of blood potassium levels by clinicians and patients themselves, which can help improve the management of chronic kidney diseases affecting 800 million people worldwide.
The company says its digital blood testing technology provides clinical-grade results without the need to visit a clinic, meaning patients’ medications and diet can be optimised and, crucially, abnormal potassium levels can be detected before severe complications arise.
The data can be integrated into third party apps and health records, along with Kalium’s own digital platform.
Kidney Research UK was one of the first major investors in the company.
Lucy Sreeves, executive director at the charity, said: “Accurately measuring potassium levels is essential for people living with chronic kidney disease. Abnormal levels of potassium in the body are dangerous and potentially life-threatening, yet they can only currently be measured through inconvenient and costly visits to clinical settings for invasive blood draws.
“This clinical study is a significant milestone in the development of this new device to empower patients to measure their own potassium levels and we look forward to seeing the results later in 2024.”
Interim results are due in February, with full results available in the spring.
By conducting data analysis in line with US FDA expectations, Kalium Health hopes to enable fast regulatory approval as it heads towards an initial launch in the US, where it can tap into the $100bn market for managing chronic kidney disease.
US healthcare leader Ranndy Kellogg, president and CEO of Omron Healthcare, was appointed to the board in November, when Kalium launched a Series A round to raise £6m ($7.3m). Several high-profile UK and US investors are in talks with the company, which also reports burgeoning interest from new investors.
Visit kaliumhealth.com for more.