TEST:

OncoaccuPanel™

"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 it agreed with Agilent Technologies Korea...to cooperate in the Korean and international next-generation sequencing (NGS) precision diagnostics market...Under the latest agreement, NGeneBio's solid cancer precision diagnostic product, ONCOaccuPanel will be applied to Agilent's Magnis NGS Prep System. Then, Agilent can sell it as a package."

Oncogenic alterations and targetable genetic alterations were detected in 98.2% and 27.4% cases, respectively. ONCOaccuPanel demonstrated high analytical sensitivity, reproducibility, and repeatability and is feasible for the detection of clinically relevant mutations in clinical settings.

"South Korean diagnostics company NGeneBio said...that it has received CE-IVD marking for its next-generation sequencing-based comprehensive genomic profiling panel for cancer, OncoaccuPanel."