Qlife starts sales of its PHE rare disease test, addressing an unmet need in the at-home testing market worth SEK 2.5 billion

Since its inception, Qlife has been developing the Phenylalanine (PHE) test capsule and is now prepared to offer it for sale to individuals with Phenylketonuria. Initially, the at-home PHE test will be available as a research-use-only (CE-RUO) product, designed to supplement existing testing routines until it receives full regulatory approval. The company plans to begin the process of registering the test as an in-vitro diagnostic (IVD) later this year, starting in the UK and expanding to the EU and other markets.

An at-home PHE test will significantly improve the quality of life for people with Phenylketonuria. Qlife's regulatory strategy involves releasing the product as a CE-RUO test, backed by sufficient data to support its initial availability. The Egoo device is already CE-marked, and the plan is to subsequently begin the registration process for the PHE capsule across multiple countries. In collaboration with PHE test laboratories worldwide, Qlife is continuously collecting data to support ongoing development and regulatory approval.

PHE pricing

The pricing is kept relatively low due to its current CE-RUO status. Once approved, the price will increase, as reimbursement for Phenylketonuria supplies is generally covered by public or private insurance. The Egoo device is priced at €295, while each PHE test costs €9.95, with a minimum order of 10 tests. The product is available for purchase in the Egoo.Health webshop at www.egoo.health/pku

CSO, Peter Warthoe comments:

“This marks a significant milestone for the company, as we are now able to offer the Phenylketonuria community a convenient at-home PHE test with a 30-minute turnaround time. Given the challenges of accessing blood samples, we are making the product available for purchase while simultaneously gathering data in collaboration with laboratories worldwide. This approach aligns with our broader strategy for addressing rare diseases, and we believe it provides individuals with Phenylketonuria access to a vital, potentially life-changing tool.”

CEO, Thomas Warthoe comments further:

“I’m thrilled that we are finally back in the market and can begin selling our products. A home PHE test has long been a major aspiration for the Phenylketonuria community, and it’s also of great interest to our Chinese partner, Hipro. The incidence rate for Phenylketonuria in China is around 1/10.000 as it is in many countries, and although PHE testing on newborns is done today, it is not as established as in western countries and lifelong routine PHE testing is especially difficult. We plan for Hipro to mass-produce this test for our global supply, while they focus on developing the Phenylketonuria market within China.”

Grants

Qlife’s Phenylketonuria project has received grants over the years from the Phenylketonuria Research Holland (Stichting PKU), the North American Phenylketonuria society (NPKUA), the Danish “Markedsmodningsfonden,” and the Danish “Innovationsfonden”.

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 01-10-2024 09:00 CET