REGULATORY | TestYourBiomarkers

PKU

Phenylketonuria (PKU) is a rare inherited disorder that causes an amino acid called phenylalanine (PHE) to build

up in the body. PKU is caused by a defect in the gene that helps create the enzyme needed to break down PHE. One out of 10.000 babies today are born with PKU, 38.000 in Europe and 100.000 in the world currently lives

with it.

Without the enzyme necessary to process PHE, a dangerous build up can develop when a person with PKU eats food that contains protein or eats aspartame,an artificial sweetener. This can eventually lead to serious health problems and brain damage.

PKU can be treated with a very strict lifelong diet that is difficult to manage, also because it, at the moment, isn’t possible for the patients to test their levels of PHE at home and adjust their diet immediately. Instead they have

to do weekly blood samples/test that they then have to wait several days for, during which their numbers could have changed again.

Qlife was at the 33erdr annual ESPKU conference in Izmir in November 2019 where we presented the Egoo Home System for the PKU community with great success. We also met with patients, clinicians and patient organizations and was confirmed in our belief that the Egoo Health System can provide advanced quality of life for people with PKU.

Qlife is focused on finalizing our capsule for the PHE measurement. For estimate of timeline please see below.

ABOUT

Qlife consist of an experienced medtech team that has worked together for many years creating point-of-care blood analyzers within the in-vitro diagnostic industry. Qlife was created to make a difference in how and

where blood analysis is performed, and allow all people easy access to blood-based clinical values that can provide the necessary knowledge to improve or prevent serious disease.

VISION

Qlife’s vision is to facilitate regular blood biomarker testing from a home environment. We aim to make blood sampling convenient, cheap, fast, accessible and accurate, resulting in more frequent blood testing to gain insight into personal health, with increased possibility for earlier discovery of illnesses. For more info about the company itself please visit qlifeholding.com and if you want to stay updated about our progress please sign

up for our newsletter here below and/or follow us on linkedin.

ABOUT

Qlife consist of an experienced medtech team that has worked together for many years creating point-of-care blood analyzers within the in-vitro diagnostic industry. Qlife was created to make a difference in how and

where blood analysis is performed, and allow all people easy access to blood-based clinical values that can provide the necessary knowledge to improve or prevent serious disease.

VISION

Qlife’s vision is to facilitate regular blood biomarker testing from a home environment. We aim to make blood sampling convenient, cheap, fast, accessible and accurate, resulting in more frequent blood testing to gain insight into personal health, with increased possibility for earlier discovery of illnesses. For more info about the company itself please visit qlifeholding.com and if you want to stay updated about our progress please sign

up for our newsletter here below and/or follow us on linkedin.

ABOUT

Qlife consist of an experienced medtech team that has worked together for many years creating point-of-care blood analyzers within the in-vitro diagnostic industry. Qlife was created to make a difference in how and

where blood analysis is performed, and allow all people easy access to blood-based clinical values that can provide the necessary knowledge to improve or prevent serious disease.

VISION

Qlife’s vision is to facilitate regular blood biomarker testing from a home environment. We aim to make blood sampling convenient, cheap, fast, accessible and accurate, resulting in more frequent blood testing to gain insight into personal health, with increased possibility for earlier discovery of illnesses. For more info about the company itself please visit qlifeholding.com and if you want to stay updated about our progress please sign

up for our newsletter here below and/or follow us on linkedin.

PKU

Qlife was at the 33erdr annual ESPKU conference in Izmir

in November 2019 where we presented the Egoo Home System for the PKU community with great success. We also met with patients, clinicians and patient organizations and was confirmed in our belief that the Egoo Health System can provide advanced quality of life for people with PKU.

Qlife is focused on finalizing our capsule for the PHE measurement. For estimate of timeline please see below.

PKU

Qlife was at the 33erdr annual ESPKU conference in Izmir

in November 2019 where we presented the Egoo Home System for the PKU community with great success. We also met with patients, clinicians and patient organizations and was confirmed in our belief that the Egoo Health System can provide advanced quality of life for people with PKU.

Qlife is focused on finalizing our capsule for the PHE measurement. For estimate of timeline please see below.

Egoo Home System has been CE-Marked for professional use for dual test capsule Hb/CRP and single test capsule Hb and CRP. Other capsules to follow.

If you are a health professional please go ahead and order the system. Please notice by ordering you certify that you are a health professional (doctor, nurse or other type of certified health professional).

If you are a private person, the product is not yet approved for sale to layman use. However, we are happy to accept your pre-order. No commitment, just fill out the form and you will be among the first to be able to purchase the product when it is cleared for sale to layman. We will contact you at the time.

Want to hear about our subscription programs, where you pay a fixed monthly and receive an Egoo device and monthly shipments of capsules. Use the form to send us an e-mail and we’ll get back to you.

Egoo Home System has been CE-Marked for professional use for dual test capsule Hb/CRP and single test capsule Hb and CRP. Other capsules to follow.

If you are a health professional please go ahead and order the system. Please notice by ordering you certify that you are a health professional (doctor, nurse or other type of certified health professional).

If you are a private person, the product is not yet approved for sale to layman use. However, we are happy to accept your pre-order. No commitment, just fill out the form and you will be among the first to be able to purchase the product when it is cleared for sale to layman. We will contact you at the time.

Want to hear about our subscription programs, where you pay a fixed monthly and receive an Egoo device and monthly shipments of capsules. Use the form to send us an e-mail and we’ll get back to you.

Egoo Home System has been CE-Marked for professional use for dual test capsule Hb/CRP and single test capsule Hb and CRP. Other capsules to follow.

If you are a health professional please go ahead and order the system. Please notice by ordering you certify that you are a health professional (doctor, nurse or other type of certified health professional).

If you are a private person, the product is not yet approved for sale to layman use. However, we are happy to accept your pre-order. No commitment, just fill out the form and you will be among the first to be able to purchase the product when it is cleared for sale to layman. We will contact you at the time.

Want to hear about our subscription programs, where you pay a fixed monthly and receive an Egoo device and monthly shipments of capsules. Use the form to send us an e-mail and we’ll get back to you.

Egoo Home System has been CE-Marked for professional use for dual test capsule Hb/CRP and single test capsule Hb and CRP. Other capsules to follow.

If you are a health professional please go ahead and order the system. Please notice by ordering you certify that you are a health professional (doctor, nurse or other type of certified health professional).

If you are a private person, the product is not yet approved for sale to layman use. However, we are happy to accept your pre-order. No commitment, just fill out the form and you will be among the first to be able to purchase the product when it is cleared for sale to layman. We will contact you at the time.

Want to hear about our subscription programs, where you pay a fixed monthly and receive an Egoo device and monthly shipments of capsules. Use the form to send us an e-mail and we’ll get back to you.

HOW HEALTHY

ARE YOU?

YOUR BLOOD HAS ALL THE ANSWERS

Today, you might have blood tests run once a year, or even less. Access to blood biomarker information is not easily accessible.

Egoo.Health plan on changing that, giving you new opportunities for monitoring your health and taking action.

Egoo Home System gives you access to clinical biomarker information so that you can actively monitor specific conditions having to do with your heart, metabolism, diabetes, thyroid or many other health concerns. Or, perhaps you are just looking for reassurance that your health status is good and your values normal.

Egoo.health want to make Egoo Home System available for everyone.

During 2020 we will launch following biomarker capsules.

Please check the timeline for each on the focus field pages.

HOW HEALTHY

ARE YOU?

YOUR BLOOD HAS ALL THE ANSWERS

Today, you might have blood tests run once a year, or even less. Access to blood biomarker information is not easily accessible.

Egoo.Health plan on changing that, giving you new opportunities for monitoring your health and taking action.

Egoo Home System gives you access to clinical biomarker information so that you can actively monitor specific conditions having to do with your heart, metabolism, diabetes, thyroid or many other health concerns. Or, perhaps you are just looking for reassurance that your health status is good and your values normal.

Egoo.health want to make Egoo Home System available for everyone.

During 2020 we will launch following biomarker capsules.

Please check the timeline for each on the focus field pages.

HOW HEALTHY

ARE YOU?

YOUR BLOOD HAS ALL THE ANSWERS

Today, you might have blood tests run once a year, or even less. Access to blood biomarker information is not easily accessible.

Egoo.Health plan on changing that, giving you new opportunities for monitoring your health and taking action.

Egoo Home System gives you access to clinical biomarker information so that you can actively monitor specific conditions having to do with your heart, metabolism, diabetes, thyroid or many other health concerns. Or, perhaps you are just looking for reassurance that your health status is good and your values normal.

Egoo.health want to make Egoo Home System available for everyone.

During 2020 we will launch following biomarker capsules.

Please check the timeline for each on the focus field pages.

HOW HEALTHY

ARE YOU?

YOUR BLOOD HAS ALL THE ANSWERS

Today, you might have blood tests run once a year, or even less. Access to blood biomarker information is not easily accessible.

Egoo.Health plan on changing that, giving you new opportunities for monitoring your health and taking action.

Egoo Home System gives you access to clinical biomarker information so that you can actively monitor specific conditions having to do with your heart, metabolism, diabetes, thyroid or many other health concerns. Or, perhaps you are just looking for reassurance that your health status is good and your values normal.

Egoo.health want to make Egoo Home System available for everyone.

During 2020 we will launch following biomarker capsules.

Please check the timeline for each on the focus field pages.

HOW HEALTHY

ARE YOU?

YOUR BLOOD HAS ALL THE ANSWERS

Today, you might have blood tests run once a year, or even less. Access to blood biomarker information is not easily accessible.

Egoo.Health plan on changing that, giving you new opportunities for monitoring your health and taking action.

Egoo Home System gives you access to clinical biomarker information so that you can actively monitor specific conditions having to do with your heart, metabolism, diabetes, thyroid or many other health concerns. Or, perhaps you are just looking for reassurance that your health status is good and your values normal.

Egoo.health want to make Egoo Home System available for everyone.

During 2020 we will launch following biomarker capsules.

Please check the timeline for each on the focus field pages.

REGULATORY

The techniques for exploring and measuring genetic biomarkers can vary. There is also a specific regulatory process in each country that manufacturers must get through before gaining approval to sell their product

in the country or region.

Currently Qlife has obtained the following certifications:

EN ISO 13485:2016 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
CE-Marking for professional use for Hb/CRP capsule. For other capsules, see the respective timelines within each field
CE-Marking for sub-test (self-test) – in process. See the respective timelines within each field

Qlife adheres to the ethical and privacy practices described in The European Charter of Fundamental Rights. It also complies with GDPR and the EU IVD regulations for self-testing.

Please contact us if you have any questions about our regulatory affairs.