The company has shifted its focus from research and development to becoming a sales-driven organization, emphasizing the distribution of its high-quality Egoo Health product platform in the rapidly expanding home diagnostics market. Qlife has successfully sold its RUO-approved Egoo Phenylalanine (Phe) system in seven countries and is currently conducting studies in the UK and Denmark to prepare submissions under IVDR EU regulations. These efforts aim to secure the necessary CE marking for the EU market, paving the way for full-scale commercialization.
The following achievements in sales and regulatory matters have been accomplished over the past months:
- Sales of Egoo Phe Systems to customers in seven countries
- UK clinical study for Phe expected to get green light by authorities, starting early 2025
- UK registration for Egoo Phe expected mid-2025, with full-scale sales to follow
- Denmark comparison study scheduled to begin early 2025
- EU submission for IVDR approval anticipated mid-2025, enabling EU sales upon approval
Sales of Egoo Phe to customers in seven countries
The company has sold the Egoo Phenylalanine (Phe) system to individual Phenylketonuria (PKU) customers in seven countries: Denmark, Sweden, Spain, the UK, Romania, Canada, and the USA. It has received numerous inquiries about the Egoo Phe system and currently maintains a database of over 1,000 people interested in using it.
Due to its current regulatory status as a research-use-only (RUO) product, the company will delay full-scale marketing efforts until a comprehensive data package can be submitted to authorities, starting with the UK. Additionally, the company, in collaboration with its strategic production partner in China, must ensure that production of the platform is fully operational to meet demand.
"We have learned so much from interacting with the PKU community. Selling a blood diagnostic product to laypeople is a completely different experience compared to selling to professionals. The PKU communities are just great, and people are more than willing to support the successful introduction of a Phe test for home use. We feel honored to be part of this and hope to contribute to improving the daily lives of those living with PKU"- Says Thomas Warthoe, CEO of Qlife.
UK clinical study for Phe is approved by authorities, starting early 2025
The company has worked diligently with Birmingham Children's Hospital to prepare and submit all required protocols and documentation for the upcoming clinical study, an essential step toward UK registration. Current procedures mandate that any clinical study must receive prior approval before commencement, simplifying the registration process once the study is concluded. The clinical study will be conducted by Birmingham Children's Hospital on regular PKU patients, with blood samples collected in participants' homes. The study is expected to last 3-6 months.
UK registration for Egoo Phe expected before mid-2025, with full-scale sales to follow
Upon completion of the clinical study in Birmingham, Qlife will be well-positioned to submit the full documentation required for regulatory approval of the Egoo Phe system in the UK. Once approved, the company anticipates initiating a full-scale launch of the product for Phe shortly thereafter.
Denmark comparison study scheduled to begin early 2025
Simultaneously with the Birmingham study, the company will be conducting a method comparison study at Rigshospitalet in Copenhagen to evaluate the Egoo Phe system against standard laboratory methodologies. This study is expected to conclude by mid-2025, further enhancing the robustness of the Egoo Phe data package.
EU submission for IVDR approval
Upon completion of the Birmingham and Copenhagen studies, the company will submit a comprehensive technical file under IVDR EU regulations to obtain a CE marking for the EU market. Approval is anticipated thereafter subject to the authorities' review.
The EU market for PKU comprises approximately 50,000 individuals. Including regions such as the Middle East, Turkey, and other neighboring markets, the addressable market expands to 75,000 individuals with PKU.
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.
For more information please contact:
Thomas Warthoe, CEO
tw@egoo.health
+45 21 63 35 34
