BGI Receives CE-IVDD Certification for Thalassemia Gene Detection Kit

China-headquartered BGI has received CE approval for its Thalassemia Gene Detection Kit under the In Vitro Diagnostic Medical Devices Directive.

The company said the device uses next-generation sequencing technology — specifically, combinatorial probe-anchor synthesis sequencing method — to qualitatively detect α-thalassemia and β thalassemia mutations that would indicate information on types of hemoglobin deficiencies.

The peripheral blood samples will be used for genetic diagnosis of patients and suspected patients with α and/or β thalassemia, abnormal hemoglobinopathy, as well as a screening of the carriage of those mutations in the population, the company said.

Hemoglobin disorders such as thalassemia constitute a serious medical and public health problem in the Mediterranean, the Middle East, North African, Central Asia, the Indian subcontinent and Southeast Asia.