All laboratory testing (except research) performed on humans in the U.S are required to be conducted under Clinical Laboratory Improvement Amendments (CLIA), regulated by the Centers for Medicare & Medicaid Services (CMS). The CLIA program regulates these laboratories to ensure accurate and reliable test results.
Our over 18,000 square feet, state-of-the-art GMP-compliant lab is California CLIA-certified and dedicated to providing the highest quality facilities that are capable of manufacturing advanced molecular diagnostic tools.
Settings for Global Trials
gLOBAL CLINICAL OPERAIONS
CLIA labs in both the U.S. and China. Both sites use the same quality system
Specialization in Genomic Testing
Specialties: gene mutation test, gene expression monitoring, genotyping, copy number analysis and next-generation sequencing
Expertise in Gene Detection
Expertise in detecting rare cancer mutations and fusion genes. Reliably detects 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations
GMP-compliant facility with CLIA and ISO 13485 certifications