Latest Update 22nd October 2025
‘As an update to the progression towards final approval in the UK and EU , we are submitting to our notified body in Q4 2025.’
Dr. Med Alex Pinto’s presentation of the final results from the clinical trial in Birmingham at the ESPKU conference 2025 in Hamburg.
Update 26th August 2025
I’m pleased to share that Qlife, in collaboration with Birmingham Women’s and Children’s NHS Foundation Trust, has successfully completed a clinical study focused on at-home self-testing for children and young people under 18 years of age. The study compared the Egoo Phe Test with the standard dried blood spot (DBS) method and showed:
- High concordance between Egoo Phe results and DBS reference values.
- Consistent classification of clinically significant results below 360 µmol/L for well-controlled PKU patients.
- High repeatability across the full measurement range.
Caregivers in the study strongly favored Egoo for its faster results, reduced blood volume, and ease of use at home—highlighting its potential to improve PKU management.
Professor Anita MacDonald will present the full data at the upcoming ESPKU annual meeting in September. Meanwhile, we are preparing for the final phase of regulatory submission for self-testing approval in the UK and under IVDR for the EU, expected to be finalized in Q4 2025.
Introduction Video
Here is an exciting introduction to the Egoo Phe Home Tester. It is currently going through clinical validation and optimization. The Egoo Phe technology has a strong focus on user experience and accuracy.