Special report: companion diagnostics: example of BRAF gene mutation testing to select patients with melanoma for treatment with BRAF kinase inhibitors
BlueCross BlueShield Association
Record ID 32012000756
English
Authors' objectives:
An important question is whether the co-development process ensures sufficient validation of the companion diagnostic test, such that an independent evaluation becomes unnecessary. This Report will address that question using a targeted drug discovery example: the recently approved vemurafenib for certain patients with melanoma and its co-approved companion diagnostic test.
Details
Project Status:
Completed
Year Published:
2011
URL for published report:
http://www.bcbs.com/blueresources/tec/vols/26/26_07.pdf
URL for additional information:
http://www.bcbs.com/blueresources/tec/vols/26/special-report-companion.html
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
United States
MeSH Terms
- Melanoma
- Molecular Diagnostic Techniques
- Molecular Targeted Therapy
- Patient Selection
- Diagnostic Techniques and Procedures
- Precision Medicine
Contact
Organisation Name:
BlueCross BlueShield Association
Contact Address:
BlueCross BlueShield Association, Technology Evaluation Center, 225 North Michigan Ave, Chicago, Illinois, USA. Tel: 888 832 4321
Contact Name:
tec@bcbsa.com
Contact Email:
tec@bcbsa.com
Copyright:
BlueCross BlueShield Association (BCBS)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.