1. Can Egoo produce the same data quality as the blood tests my doctor orders?
Yes. The results we provide are exactly the same as what you would get from your doctor. Just as your doctor would do, we use whole blood samples. We are regulated the same way and follow the same guidelines.
2. Please explain how the Egoo tests are the same what my doctor would order. How does that work?
The Egoo device is constructed in the same way as devices used in large laboratories. The methodology, components, reagents and chemistries are the same and we use whole blood, just like in standard laboratories. Our achievement has been to miniaturize it into a small box and then make it simple to use for anyone.
3. Does one capsule measure only one biomarker?
In principle yes. This is because it is necessary to have an adequate volume of blood in order to guarantee high quality of results. One drop of blood only provides enough volume for measuring one biomarker at a time, simultaneously guaranteeing the quality of results. In a few cases, like with CRP and HB, it can measure both using just one drop of blood.
4. Is Egoo a medical device?
Yes, it is a medical device. And as such, we must meet the same standards required for all other devices used by your doctor. We meet the regulatory requirements in Denmark and the EU and are in the process of obtaining all of the required certifications.
5. Does Egoo follow regulatory guidelines?
Yes, Egoo follows the regulatory guidlines for professional use of the product and for self-test use of the product. Devices for self-testing must be designed and manufactured in such a way as to ensure that the device is easy to use by the intended user, reduce the risk of user error in the handling of the device and in the interpretation of the results.
6. Has Egoo obtained FDA approved for marketing in the USA?
No, not yet. Egoo has not obtained FDA approval.
The regulatory approval process differs from country to country. We must get through the process of each specific country and gain approval before the device can be marketed and sold there.
7. How does Egoo manage data privacy?
Personal data is private and must be protected. We understand that your medical data is extremely sensitive information. Accordingly, our system has been designed such that we are unable to access your data. We simply provide a structure for storing it in the cloud and sharing it with entities that you have approved, such as your hospital or physician.
8. Can the data be shared with my doctor, clinic or hospital?
Yes. Through the Egoo Cloud, the data can be shared with any ICT system provided it is connected and certified (e.g. medical records, doctor local IT systems or other databases).
9. Is Egoo required to be validated in clinical trials?
Yes, as part of the regulatory processes in the EU, we are required to run studies and create a technical file for each biomarker, which is either self-certified or approved by the local notified body.