TEST:

BRCAaccuTest PLUS

"NGENBIO...announced on the 8th that it had renewed ISO 13485:2016, a European medical device quality management system certification, for 7 consecutive years. ISO 13485 certification is an international standard certification that ensures that medical device manufacturers comply with product quality , safety and regulatory requirements, and is an essential holding condition for obtaining CE-IVDR certification, a European in vitro diagnostic device certification...Accordingly, NgenBio preemptively acquires 'BRCAaccuTest PLUS', a diagnostic product for hereditary breast and ovarian cancer, and 'ONCOaccuPanel', a precise diagnostic test product for solid cancer, with the goal of obtaining IVDR CE certification within 2024, and exports them to the European market. is going to expand."

"NGeneBio said on Thursday that it launched its next-generation sequence (NGS)-based breast cancer diagnostic service in a newly installed inspection laboratory of a Thai consignment inspection agency, MP Group....NGeneBio plans to provide its NGS-based precision diagnosis services to medium and large hospitals, government-affiliated medical institutions, health centers, and the general public through MP Group's newly opened laboratory. The service launched by the MP Group laboratory uses NGeneBio’s BRCAaccuTest PLUS test to identify the BRCA gene which is related to breast cancer and ovarian cancer."