International Organization for Standardization (ISO) Accreditation

Agiomix has received the ISO 15189:2012 Accreditation from the Emirates International Accreditation Centre for Next Generation Sequencing clinical assays on January 2021.

With this additional reputable international accreditation, Agiomix now has the unique capacity to offer its healthcare partners and patients, unparalleled clinical diagnostics services in the area of genetics. We are very pleased and honored by this accreditation and we look forward to more international recognition as our services and family grow.

ISO accreditation will add the Lab’s strength and ability to lead the area in clinical genetics applications.

College of American Pathologists (CAP) Accreditation

The College of American Pathologists (CAP) is an internationally recognized leader in laboratory quality assurance and excellence in healthcare. The purpose of CAP laboratory accreditation is to ensure laboratories provide precise test results for accurate patient diagnoses and demonstrate compliance with scientifically approved laboratory operating standards.

CAP-accredited laboratories are required to have a quality management program that validates the quality and safety of laboratory medical services as well as external quality assurance (also called proficiency testing) which establishes laboratory quality and is monitored on a continual basis.

CAP Proficiency Testing

Agiomix is committed to providing high quality, accurate and consistent clinical reporting. As a part of this commitment, Agiomix participates in multiple Proficiency Testing Schemes that ensures that our laboratory is meeting the highest standards of quality.

Proficiency testing is an ongoing, rigorous routine which involves receipt of unknown samples that need to be tested against pre-defined parameters. The results of which are submitted to CAP. This testing allows Agiomix to ensure that our technical competency is maintained and provide information to continuously monitor the laboratory’s performance. It also guarantees that Agiomix is keeping up with the rapidly evolving changes in laboratory medicine and technology.

CAP Proficiency Testing Statistics

Test NameTest CodeAnalyteEvaluation DateScore%Cumulative Performance
OncoSeq BRCA24104BRCA 1/2 Sequencing Analysis12/15/20203/3100Successful
OncoSeq BRCA24104BRCA Clinical Interpretation12/15/20203/3100Successful
OncoSeq BRCA24104BRCA 1/2 Sequencing Analysis3/23/20203/3100Successful
OncoSeq BRCA24104BRCA Clinical Interpretation3/23/20203/3100Successful
HBV, HCV, HIV Qualitative Detection41102
Viral Identification11/16/20204/4100Successful
HBV, HCV, HIV Qualitative Detection41102
Viral Identification11/21/20205/5100Successful
HPV Qualitative Detection41106Viral Identification12/8/20202/2100Successful
HCV Quantitative Detection41103HCV Viral Load2/21/20205/5100Successful
HCV Quantitative Detection41103HCV Viral Load11/23/20205/5100Successful
HCV Qualitative Detection41102HCV, Qual11/23/20201/1100Successful
HCV Qualitative Detection41102HCV, Qual2/21/20201/1100Successful
HIV Quantitative Detection41108HIV Viral Load3/6/20205/5100Successful
HIV Quantitative Detection41108HIV Viral Load11/16/20205/5100Successful
HLA-B2743101HLA-B27 Antigen Typing12/21/20205/5100Successful
Factor V, Factor II Mutation Screening44102
FVL Genotype (TPM)11/5/20203/3100Successful
Factor V, Factor II Mutation Screening44103
FVL Interpretation (TPM)11/5/20203/3100Successful
Factor II Mutation Screening44103Factor II Genotype (TPM)11/5/20203/3100Successful
Factor II Mutation Screening44103Factor II Interpretation (TPM)11/5/20203/3100Successful