The Egoo Phe System, developed to measure phenylalanine (Phe) levels associated with the PKU condition, is now entering its final phase ahead of initial registration in the UK and submission to a Notified Body for self-testing approval by non-professional users in the UK, as well as under the IVDR for EU markets.
The clinical trial will run for six months in the UK, after which the dossier will be submitted to the relevant UK authorities. As self-testing by non-professional users represents the highest classification for an In-Vitro Diagnostic (IVD) product, the application must also be reviewed by a Notified Body before final approval and market launch. The company anticipates completing the process and releasing the product to market in early Q4 of this year
""It is a green stamp for us that the UK authorities now allow the clinical trial to start. We have spent the past four months fulfilling all the registration obligations with the Ethics Committee, Health Research Authority (HRA), and the Medicines and Healthcare products Regulatory Agency (MHRA). Technical documents are filed, and we now await the clinical study outcome. We are confident about the study, as we already conducted a similar clinical trial in the USA last summer with a positive outcome. We are very pleased with the progress Qlife has made recently and are truly excited about the future", says Thomas Warthoe, CEO Qlife.
There is currently no self-testing Phe product available on the market. For people living with the PKU condition, adjusting their diet is crucial, as excessive protein intake can lead to serious health issues. Access to a 30-minute IVD test is therefore expected to be a game-changer. Today, data is only accessible through cumbersome laboratory testing, even though it is needed on a daily or at least weekly basis to better manage dietary adjustments.
In the UK, approximately 5,000 individuals are affected by the PKU condition; in the EU, around 50,000 individuals; and in the Middle East, an additional 20,000 people. With an average usage of one Egoo Phe Test per person per week, the immediate Total Addressable Market (TAM) for the UK/EU/Middle East region exceeds SEK 1 billion.
For more information please contact:
Thomas Warthoe, CEO
tw@egoo.health
+45 21 63 35 34
About Egoo Health
Egoo Health enables advanced clinical-grade biomarker testing at home. The aim is to give people access to important health data at the clinical-grade level. Egoo Health is an integrated platform, consisting of a small diagnostic device, a blood-to-plasma collector, a disposable capsule that contain test reagents for a specific biomarker and the Egoo smartphone app that operates the system and can share data with health authorities.
