Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Gothenburg, Sweden - Qlife Holding AB ("Qlife" or the "Company") announces that it has finalized its clinical study for children and young people under 18 years of age. The study was focused on the self-test at-home aspect and the comparison of data to standard of care methodology DBS-cards (Dried Blood Spots). The study and the enrollment were completed under the leadership of Professor Anita MacDonald, Professor in Dietetics at Birmingham Women's and Children's NHS Foundation Trust.
Summary of results:
- High concordance between Egoo PHE Test results and the Dry Blood Spot (DBS) reference method.
- Results below 360 µmol/L, which are clinically significant for well-controlled PKU patients, were consistently classified by both methods, and concordance remained high across the full measurement range.
- High repeatability was demonstrated within the full measurement range.
Professor Anita MacDonald will present data from the study at the upcoming European Society for PKU (ESPKU) annual meeting in September.
The Egoo PHE system is entering its final phase ahead of submission to a Notified Body for self-testing approval in the UK and under the IVDR for EU markets. As a self-testing by non-professional users Egoo PHE represents the highest classification for an In Vitro Diagnostic (IVD) product. Qlife expects to finalize the submission process during Q4 2025 and await Notified Body market allowance.
Professor Anita MacDonald commented:
"Accurate and timely measurement of phenylalanine levels is essential for the management of Phenylketonuria (PKU), particularly in children and young people. In this study of children with phenylketonuria (PKU), blood samples analysed using the Egoo system showed strong alignment with traditional dried blood spot (DBS) results. Caregivers unanimously favoured Egoo for its faster results, reduced blood volume, and ease of use at home, demonstrating its potential to improve PKU management".
Qlife CSO's Peter Warthoe commented:
"We are extremely grateful to Anita and her team for having dedicated so much time and enthusiasm to finalize this important study involving among many other things going to people's home on a routine basis for the past 6 months, getting the test done and collecting data. It has been a huge effort, and we are therefore even more happy to see that the Egoo PHE lives up to our expectation. We look forward to continuing towards a final IVDR approval before we turn towards the US market."
PKU condition
There is currently no self-testing phenylalanine product on the market. The UK PKU population is estimated at 5,000 individuals, the EU population at 50,000, and the Middle East population at 20,000. With an average usage of one Egoo Phe Test per person per week, the immediate total addressable market for the UK/EU/Middle East region is estimated to exceed SEK 1 billion.
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">21-08-2025 08:30 CET.