Axial Biotech Accreditation
We are dedicated to delivering the highest quality of service to healthcare providers and their patients. Our laboratory meets all good manufacturing practices (GMP) and good laboratory practices (GLP) by receiving accreditation from the College of American Pathologists (CAP); is certified to comply with the Clinical Laboratory Improvement Amendments (CLIA) of the Centers for Medicare & Medicaid Services; and meets the ISO 17025 requirements.
To view all Axial Biotech accreditation certificates, click here.
Regulatory Compliance Overview
Genetic Laboratories must meet the highest regulatory and compliance standards to ensure quality testing. We exceed those standards, guaranteeing reliable and reproducible testing results.
CLIA Certification
The Centers for Medicare & Medicaid Services (CMS) regulate all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). We meet all of the requirements needed to acquire CLIA approval and certification which allows us to perform tests for "clinical" use.
- Our Certificate of Compliance CLIA ID#: 46D1077919
CAP Accreditation
The College of American Pathologists Laboratory Accreditation Program is an internationally recognized program designed to go beyond regulatory compliance, helping laboratories achieve the highest standards of excellence to positively impact patient care.
The Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority for genetic testing in the United States. It is also recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and can be used to meet many state certification requirements. CLIA also recognizes CAP as an official accrediting agency.
CAP Accreditation includes the following criteria:
- Director and Organizational Assessment: to ensure that the laboratory's leadership, organizational structure, and staff are highly qualified and sufficient to support the testing services being offered.
- General Laboratory: to ensure that the standard operating procedures are scientifically valid and uphold best practices in the laboratory.
- Molecular Pathology: to ensure that the specific molecular diagnostics services, including genetic and parentage testing, are performed according to quality standards established by scientific leaders in the industry.
Participation in the CAP accreditation program is voluntary, but essential in the genetic testing industry, which is not regulated by the government. Laboratories that wish to maintain high-quality services submit to this accreditation program, which upholds strict laboratory standards. CAP accreditation requires a biennial, unannounced on-site inspection of the facility, as well as routine laboratory proficiency testing throughout the period in which a laboratory is accredited.
- Our CAP Accreditation Number is: LAP # 7207154
Food and Drug Administration Regulations
Most genetic tests are developed as Laboratory Developed Tests (LDTs) which are regulated under the Clinical Laboratory Improvement Act of 1988 (CLIA), not by the FDA. Therefore, our test has not been cleared or approved by the U.S. Food and Drug Administration.
The FDA has established regulations for the active ingredients used to perform these LDT tests. These active ingredients are known as Analyte Specific Reagents (ASRs) and must be produced by certified good manufacturing practices (GMP) vendors. All ASRs we use are provided by GMP vendors.
The FDA is developing a template for reviewing LDT genetic tests as recommended by the Secretary's Advisory Committee on Genetic Testing (SACGT).
Explanation letter of FDA Status for ScoliScore™ Test.
GLP Standards
We have completed all of the requirements and internal audits associated with Good Laboratory Practice (GLP) guidelines. GLP compliance involves the development and implementation of consistent controls for sample processing, equipment and process validations, training, audits and document control.
