BGI’s Clinical Test Laboratory in Denmark Passes European Quality Assessment of BRCA with Full Marks
Publish Date: 2018-07-31
The European Molecular Genetics Quality Network (EMQN) has given BGI’s Copenhagen lab full marks in its external quality assessment (EQA) results of BRCA (Full Scheme), affirming the lab’s capability of genotyping and interpretation.
While gene tests of precision medicine for cancer have developed rapidly, issues of standardized management and quality of the tests have received increasing attention. In 2015, EQMN initiated the Familial Breast and Ovarian Cancer (BRCA1 and BRCA 2) program, an international EQA program that aimed to promote standardized management of cancer test in hospitals and testing organizations globally. EMQN’s EQA schemes are designed to test the whole analytical process of a molecular diagnostics laboratory.
By testing three samples, the EQA can comprehensively estimate the laboratory capabilities of the BRCA test in genotyping, interpretation, and patient identifiers, as well as clerical accuracy. BGI’s Lab in Denmark passing this test with full marks in 2018 means the standardization and accuracy of BGI’s cancer gene test have achieved international standards.
Moreover, BGI’s BRCA test also passes the external quality assessment of the Ministry of Health in China (Germline Mutation) and the College of American Pathologists (CAP) of USA with full marks. BGI now has successfully transferred its domestic clinical test to its Denmark lab, passing the BRCA test of EMQN the first time. This means BGI’s BRCA test has entered the global market with international standards of quality.
About the BRCA Gene Test
BRCA 1 and BRCA 2 are well-known antioncogenes. If some loci of BRCA mutate, the tumor-suppressing protein will change and the normal function of DNA repairing will be restricted, which leads to accumulating DNA damage that can lead to cancer. Carriers of such gene mutations have a higher than normal risk of developing breast or ovarian cancer. Women who have a BRCA1 or BRCA2 mutation (or both) can have up to an 80% risk of being diagnosed with breast cancer during their lifetime's Health management, screening and early intervention can significantly reduce cancer incidence for carriers. Meanwhile, new PARP inhibitor drugs for BRCA gene mutations entering the market bring promising treatment options for breast and ovarian cancer patients.
About EMQN
European Molecular Genetics Quality Network (EMQN) was established at St. Mary’s Hospital of Manchester, British in 1998. It is a non-profit organization for providing external quality assessment (EQA) to labs across the world and dedicates to maintain and raise the standards of diagnostic clinical molecular genetic test.