CLIA Certification

 Diagnomics Lab
San Diego, CA
Last Updated: February 23, 2025

Diagnomics Lab, a premier biotechnology company located in San Diego, California, specializes in genomics analysis for research and clinical sample DNA testing. We are committed to upholding the highest standards of laboratory quality and accuracy through certification under the Clinical Laboratory Improvement Amendments (CLIA). This statement outlines our dedication to meeting CLIA requirements, ensuring reliable and actionable results for our clinical testing services.

Diagnomics Lab is CLIA certified (Certificate #05D2103644) and operates in accordance with CLIA standards. For verification, contact CMS or our team directly.

The Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services (CMS), establish federal standards for laboratories that perform testing on human specimens for diagnosis, prevention, or treatment purposes. CLIA certification ensures that our laboratory meets strict guidelines for quality control, personnel qualifications, and testing accuracy, providing confidence to healthcare providers and patients who rely on our clinical DNA testing services.

At Diagnomics Lab, we align our operations with CLIA regulations to deliver precise and dependable genomic analysis for clinical applications. Key aspects of our CLIA compliance include:

1. Quality Control and Assurance
   We implement rigorous quality control measures to monitor the accuracy and reliability of our DNA testing processes. Regular assessments and validations ensure consistent performance across all clinical analyses.
2. Qualified Personnel
   Our laboratory is staffed by skilled professionals, including scientists and technicians, who meet CLIA’s personnel qualification standards. Our team is trained in molecular diagnostics and genomics, with ongoing education to maintain expertise.
3. Validated Testing Procedures
   We use standardized, validated methods for clinical DNA testing, including sample preparation, genomic sequencing, and result interpretation. All procedures comply with CLIA requirements for high-complexity testing.
4. Equipment and Technology
   Our state-of-the-art laboratory in San Diego is equipped with advanced instrumentation that undergoes routine maintenance, calibration, and performance verification to meet CLIA standards.
5. Proficiency Testing
   We participate in CLIA-approved proficiency testing programs to benchmark our performance against national standards, ensuring the accuracy of our clinical test results.
6. Patient-Centric Reporting
   Results from our clinical DNA testing are reported in a clear, timely manner to healthcare providers, adhering to CLIA guidelines for documentation and communication.
7. Compliance with Federal Regulations
   In addition to CLIA, we integrate compliance with related regulations, such as HIPAA, to protect patient privacy and secure protected health information (PHI) generated during testing.

CLIA certification is a cornerstone of our clinical testing services, ensuring that healthcare providers and patients in San Diego and beyond can trust the results of our genomic analyses. Whether supporting disease diagnosis, personalized medicine, or treatment planning, our CLIA-certified laboratory delivers quality and precision you can depend on.

Diagnomics Lab is proudly headquartered in San Diego, California, a leader in biotechnology innovation. For inquiries about our CLIA certification or clinical testing services, please contact us:

• Email: info@diagnomicslab.com
• Phone: (800) 605-8422
• Address: Diagnomics Lab, 5050 Murphy Canyon Rd. #150, San Diego, CA 92123, U.S.A.

We may revise this CLIA Certification Statement periodically to reflect changes in our certification status, processes, or regulatory requirements. The most current version will always be available on this webpage, with the “Last Updated” date noted above.