The network is called GENDIA (for GENetic DIAgnostics), and currently consists of more than 100 laboratories.
The participating laboratories can be classified into three groups:
Test labs: more than 100 expert laboratories from the USA, Europe and Australia perform the molecular tests. These ‘test labs’ are experts on the diseases they are selected to diagnose. GENDIA assists these laboratories in obtaining larger numbers of patient samples, enabling them to improve the efficiency of the genetic testing. This will improve quality of testing, and lead to a reduction of costs and prices. All the test labs issue detailed English reports on the results of the tests to GENDIA.
Referral labs: the referral labs represent the Network at the regional level. In small countries there is one laboratory functioning as referral lab. In large countries there are multiple referral labs. The referral labs collect material (usually blood samples), isolate DNA and decide whether they will perform the analysis themselves or forward the DNA to the test laboratories through GENDIA. The referral labs translate the report to the local language, and issue them to the local clinicians or referring party.
The Central Laboratory: GENDIA in Belgium functions as coordinating Central Laboratory. One of its major tasks within the network is to fulfill a ‘clearing-function’ by distributing DNA to the test laboratories. Although the test laboratories cover a large list of genetic diseases, there will always be tests that are not offered in the network. GENDIA seeks qualified laboratories able to perform these specific tests (‘ad-hoc partners’).
The GENDIA network described above has several advantages over the current situation.
The accessibility to genetic tests is increased. In countries with already developed molecular diagnostics, the network facilitates testing for rare diseases not covered by local labs.
In countries with a less developed system for genetic diagnosis GENDIA provides access to many tests through the local referral labs. These labs can offer all the tests that the network is offering in their own country. GENDIA currently offers over 3000 genetic tests.
Furthermore, it is no longer necessary for referring clinicians or local labs to look for the right laboratory to perform a particular test, as all samples can be sent to the central lab of the network in Belgium.
The costs of the genetic tests will be reduced by implementation of more efficient handling and automation of the testing, which is only feasible when concentrating diagnostic work on an international scale increases the number of requests per test. The reduced costs will further facilitate access to genetic tests for patients in developing countries and for less well-insured individuals. Thus, a steadily increasing number of individuals will have access to a great spectrum of genetic services.
A third advantage of the network is the improved quality of the testing. It is very important that the results are correct and reproducible, and turn-around-times short. Furthermore, the reports must not only contain genotype information but also relevant genetic recommendations. The GENDIA test labs all have or are in the process of getting accreditation such as CLIA or ISO 17025. Additionally, ethical guidelines must apply at all times. GENDIA will monitor the quality aspects and promote improvements where possible.
GENDIA is compliant with the new European Privacy legislation referred to as GDPR (General Data Protection Regulation).
In order to ensure maximal protection of patient information GENDIA nor its test labs nor its customers (referral labs, physicians, midwives, patients) use patient names linked to personal information, and work with patient codes in stead of patient names. Therefore, at all time personal information is pseudonimised.
Customers therefore can never submit patient names linked to personal data to GENDIA. Should such data are submitted to GENDIA, GENDIA will delete these from all its IT and PC systems. As no such data are recorded and stored at GENDIA, GENDIA can also not transmit any personal data linked to patient names to its test labs.
WHAT IS GDPR ? The GDPR (General Data Protection Regulation) is the new European privacy legislation that entered into force on May 25, 2018. The GDPR automatically applies to individuals and companies that process personal data for professional use, and must ensure that they process all personal data GDPR-compliant.
GENDIA GENDIA (GENetic DIAgnostic Network) is a center that offers genetic advice (genetic counseling) and genetic testing.
GENDIA receives personal information and a sample (blood, saliva, mouth swap, DNA) from the patient that is submitted by the client, which can be the patient himself as well as the doctor or laboratory of the patient.
GENDIA submits this sample with limited clinical information on the patient to its testlabs to perform genetic testing.
PERSONAL INFORMATION AND SAMPLES
WHAT PERSONAL INFO IS COLLECTED? GENDIA itself does not actively collect patient-related data.
All personal data that GENDA has in its possession are submitted by its clients (doctors, midwives, laboratories and patients) via the submission form(s).
The submission form contains the following personal information:
Administrative information concerning the patient:
Patient code (no patient name)
Date of birth
Place of residence (only when the patient is the client)
Telephone (only when the patient is the client)
Email (only when the patient is the client)
Administrative information concerning the doctor, midwife or laboratory of the patient:
In summary, GENDIA processes the personal data exclusively for the generation of:
A submission form to the test laboratory that carries out the genetic test at the request of GENDIA
An invoice that GENDIA addresses to the client
A result letter addressed exclusively to the client and, if requested by the client, the care provider (doctor or midwife)
DOES GENDIA PROVIDE PERSONAL INFORMATION TO THIRD PARTIES? GENDIA will only send personal data to:
The care provider specified by the client on the submission form
The test laboratory that carries out the genetic test at the request of GENDIA
PSEUDONIMISATION OF SAMPLES GENDIA pseudonises all its patients’ samples by:
asking the clients (doctors, laboratories and patients) not to take patient names but to use patient codes in all documents containing clinical information (including the submission forms)
on the submission form (which the clients send to GENDIA together with the sample) no patient names but patient codes need to be filled in
if the client (doctors, laboratories and patients) still uses a patient name GENDIA replaces the patient name with a patient code on all documents where a patient name is linked to clinical information (submission forms, lab results, GENDIA reports) by replacing the patient name with a GENDIA code: year, followed by a 5-digit number: eg 2018.03458).
CUSTOMER RIGHTS ON INSPECTION, ADJUSTMENT AND REMOVAL OF PERSONAL INFO Storage period The personal data processed for customer management will be retained for the period necessary to comply with legal requirements (including in the field of accounting). Right of access, correction, erasure, restriction, objection and transferability of personal data The customer has the right to inspect his personal data at all times and can have them removed or corrected if they are incorrect or incomplete. In addition, the customer has the right to obtain a copy (in a structured, current and machine-readable form) of his personal data and to have the personal data forwarded to another company. In order to exercise the above rights, the customer is asked to send an e-mail to the following e-mail address: info@GENDIA.net Complaints The customer has the right to file a complaint with the Commission for the Protection of Privacy (Drukpersstraat 35, 1000 Brussels – email: firstname.lastname@example.org).
WEBSITES GENDIA cvba has the following websites:
GENDIA: Our general website with information about all our tests: www.GENDIA.net.
The general terms and conditions applicable to the websites are described in the GENDIA disclaimer, published on the GENDIA websites. By accessing and using one of our websites, the client expressly agrees to these terms and conditions.
IT SECURITY GENDIA works within the secure IT network of AML (www.aml-lab.be)