Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Qlife, a first mover in clinical-grade home diagnostics, and its partner Hipro Biotechnology are advancing two additional biomarker tests-nt-proBNP and potassium-into clinical trials targeting Congestive Heart Failure. This move corresponds with increasing attention from global In Vitro Diagnostic (IVD) companies, and there are plans to partner this product line during or after the clinical trial phase.
Following successful clinical documentation of the self-test PHE for the rare disease Phenylketonuria and progression towards regulatory approval under EU IVD Regulative, Qlife and Hipro are now ready to start clinical trials with two proprietary tests in the congestive heart failure field. This collaboration also supports ongoing merger activities between Qlife and Hipro.
Heart failure is a significant public health concern. Currently, no approved home self-tests are available for monitoring, requiring patients to visit laboratories for blood testing. Upon completion of clinical documentation, the plan is to submit applications for nt-proBNP and potassium tests for approval in the EU, China, and the US. There is anticipated high demand for a self-test for congestive heart failure in all these markets.
"We are very happy to advance our strategy of introducing significant biomarker tests for home use that address critical medical conditions. With the successful validation of our Egoo Health platform for immunodiagnostics through the PHE test, we are poised to enter a much broader market with two new tests targeting heart failure. As healthcare resources face increasing demands, our solutions offer vulnerable patients the ability to remain at home while maintaining access to essential clinical blood testing," stated Thomas Warthoe, CEO of Qlife.
About Congestive heart failure
Heart failure is an expanding public health issue, with an estimated global prevalence of 64 million people. Contributing factors include an aging population, increased survival rates post-heart attack, and improvements in treatment and patient outcomes, leading to a heightened need for decentralized and at-home monitoring.
This disclosure contains information that Qlife Holding AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on "This placeholder will be replaced with the correct date and send time">"This placeholder will be replaced with the correct date and send time">2025-09-15 08:30 CET.