ISO/IEC 17025:2017 Certification
"Genomics is equipped with multiple state-of-the-art sequencing systems, including the ABI 3730XL and Illumina NovaSeq, providing NGS sample sequencing. The “Genomics Laboratory” is the first in the nation to be certified by TAF with ISO 17025 certification, establishing it as an internationally recognized sequencing standard laboratory. ISO 17025 is a stringent quality certification system that recognizes laboratory capabilities, granting global recognition upon certification.
Certified items include:
◆Sanger nucleic acid sequencing
◆WES whole exome sequencing for humans
◆Strain identification
◆Fragile X Syndrome genetic testing
◆SMN gene testing for Spinal Muscular Atrophy"
ISO9001
Following the hardware inspection of the nucleic acid and peptide pilot plant, which passed GMP inspection last year (2022), CDMO operations have officially commenced. Early this year, the plant also received ISO 9001 certification for the updated quality management system. The facility continues trial production and validation of nucleic acid adjuvants, primarily to meet customer needs.
TFDA LDTs Registration
"In response to the requirements of the Special Control Act, Genomics Laboratory has been registered with the Taiwan FDA for LDTs to comply with regulatory and quality technical requirements.
Registered LDTs items include:
◆Fragile X Syndrome genetic testing
◆SMN gene testing for Spinal Muscular Atrophy"
Proficiency Testing
"Genomics has successfully passed proficiency tests conducted by the following organizations:
◆Germany's INSTANT
◆USA's CAP"
