Work package 4 Control Materials (CM)

It is clearly in the interests of the health and safety of EU citizens that the results they receive from genetic testing laboratories should be demonstrably as accurate as possible. Without adequate control materials, the accuracy of the results cannot be independently assured. Results from EQA schemes indicate, however, that there are still significant gaps in the availability and use of Control Materials (CM), especially for quantitative and semi-quantitative tests. Meanwhile, advances in genetic testing technology continue to create requirements for new types of CM.

CM based on characterizing existing genomic DNA materials can be used in a wider range of genetic tests. This approach, pioneered by EuroGentest NoE, can be more widely applied so that existing control materials, already in use as controls for tests for single-gene disorders, can, for example, also be used as controls in tests for copy-number variation.

This work package will bring together users and producers of control materials to encourage the identification of needs in the area and the development of new materials. Particular focus will be given to CM for quantitative tests (e.g. triplet repeat sizing) and new technologies such as NIPD, CNV analysis and next-generation sequencing. A network of CM labs will be established to validate existing materials for use as controls.

Through our experience in CRMGEN and EuroGentest NoE, we have also learned that the generation of approved and CE marked reference materials is very difficult, and extremely costly. Hence, in this project we will favour the practical approach, which is to promote the availability of valid and valuable CM, and enhance their use in diagnostics.

Links with the Centers for Disease Control and Prevention [1]’s “GeT-RM” programme will be developed and strengthened to ensure coordination, enhance cooperation and avoid duplication of effort.

 

WPLeader: David Barton

Participants: Mike Morris, Emmanuelle Girodon, Brian Fowler

More information on Control Materials can be found here.

 

 


[1] Centers for Disease Control and Prevention (CDC) is a component of the US Department of Health and Human Services. It serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities in the US.

Work package 4 Control Materials (CM)

It is clearly in the interests of the health and safety of EU citizens that the results they receive from genetic testing laboratories should be demonstrably as accurate as possible. Without adequate control materials, the accuracy of the results cannot be independently assured. Results from EQA schemes indicate, however, that there are still significant gaps in the availability and use of Control Materials (CM), especially for quantitative and semi-quantitative tests. Meanwhile, advances in genetic testing technology continue to create requirements for new types of CM.

CM based on characterizing existing genomic DNA materials can be used in a wider range of genetic tests. This approach, pioneered by EuroGentest NoE, can be more widely applied so that existing control materials, already in use as controls for tests for single-gene disorders, can, for example, also be used as controls in tests for copy-number variation.

This work package will bring together users and producers of control materials to encourage the identification of needs in the area and the development of new materials. Particular focus will be given to CM for quantitative tests (e.g. triplet repeat sizing) and new technologies such as NIPD, CNV analysis and next-generation sequencing. A network of CM labs will be established to validate existing materials for use as controls.

Through our experience in CRMGEN and EuroGentest NoE, we have also learned that the generation of approved and CE marked reference materials is very difficult, and extremely costly. Hence, in this project we will favour the pra

Work package 4 Control Materials (CM)

It is clearly in the interests of the health and safety of EU citizens that the results they receive from genetic testing laboratories should be demonstrably as accurate as possible. Without adequate control materials, the accuracy of the results cannot be independently assured. Results from EQA schemes indicate, however, that there are still significant gaps in the availability and use of Control Materials (CM), especially for quantitative and semi-quantitative tests. Meanwhile, advances in genetic testing technology continue to create requirements for new types of CM.

CM based on characterizing existing genomic DNA materials can be used in a wider range of genetic tests. This approach, pioneered by EuroGentest NoE, can be more widely applied so that existing control materials, already in use as controls for tests for single-gene disorders, can, for example, also be used as controls in tests for copy-number variation.

This work package will bring together users and producers of control materials to encourage the identification of needs in the area and the development of new materials. Particular focus will be given to CM for quantitative tests (e.g. triplet repeat sizing) and new technologies such as NIPD, CNV analysis and next-generation sequencing. A network of CM labs will be established to validate existing materials for use as controls.

Through our experience in CRMGEN and EuroGentest NoE, we have also learned that the generation of approved and CE marked reference materials is very difficult, and extremely costly. Hence, in this project we will favour the practical approach, which is to promote the availability of valid and valuable CM, and enhance their use in diagnostics.

Links with the Centers for Disease Control and Prevention[1]’s “GeT-RM” programme will be developed and strengthened to ensure coordination, enhance cooperation and avoid duplication of effort.

WPLeader: David Barton (P5)

Participants: Mike Morris (P10), Emmanuelle Girodon (P7), Brian Fowler (P11), Helen White (A10)


[1] Centers for Disease Control and Prevention (CDC) is a component of the US Department of Health and Human Services. It serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities in the US.

Work package 4 Control Materials (CM)

It is clearly in the interests of the health and safety of EU citizens that the results they receive from genetic testing laboratories should be demonstrably as accurate as possible. Without adequate control materials, the accuracy of the results cannot be independently assured. Results from EQA schemes indicate, however, that there are still significant gaps in the availability and use of Control Materials (CM), especially for quantitative and semi-quantitative tests. Meanwhile, advances in genetic testing technology continue to create requirements for new types of CM.

CM based on characterizing existing genomic DNA materials can be used in a wider range of genetic tests. This approach, pioneered by EuroGentest NoE, can be more widely applied so that existing control materials, already in use as controls for tests for single-gene disorders, can, for example, also be used as controls in tests for copy-number variation.

This work package will bring together users and producers of control materials to encourage the identification of needs in the area and the development of new materials. Particular focus will be given to CM for quantitative tests (e.g. triplet repeat sizing) and new technologies such as NIPD, CNV analysis and next-generation sequencing. A network of CM labs will be established to validate existing materials for use as controls.

Through our experience in CRMGEN and EuroGentest NoE, we have also learned that the generation of approved and CE marked reference materials is very difficult, and extremely costly. Hence, in this project we will favour the practical approach, which is to promote the availability of valid and valuable CM, and enhance their use in diagnostics.

Links with the Centers for Disease Control and Prevention[1]’s “GeT-RM” programme will be developed and strengthened to ensure coordination, enhance cooperation and avoid duplication of effort.

WPLeader: David Barton (P5)

Participants: Mike Morris (P10), Emmanuelle Girodon (P7), Brian Fowler (P11), Helen White (A10)


[1] Centers for Disease Control and Prevention (CDC) is a component of the US Department of Health and Human Services. It serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities in the US.

ctical approach, which is to promote the availability of valid and valuable CM, and enhance their use in diagnostics.

Links with the Centers for Disease Control and Prevention [1] ’s “GeT-RM” programme will be developed and strengthened to ensure coordination, enhance cooperation and avoid duplication of effort.

WPLeader: David Barton (P5)

Participants: Mike Morris (P10), Emmanuelle Girodon (P7), Brian Fowler (P11), Helen White (A10)




[1] Centers for Disease Control and Prevention (CDC) is a component of the US Department of Health and Human Services. It serves as the national focus for developing and applying disease prevention and control, environmental health, and health promotion and health education activities in the US.

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