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.
The GENDIA lab in Antwerp, Belgium functions as central laboratory.
All samples, results, invoices and other correspondence can be sent to:
Emiel Vloorsstraat 9
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 referral labs/physicians/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.
”Requestors” 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.
The “requestor” is responsible for getting informed consent from the patient whose sample is analysed according to the informed consent regulations of the country where the patient resides.