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.
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Settings for Global Trials
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gLOBAL CLINICAL OPERAIONS
CLIA labs in both the U.S. and China. Both sites use the same quality system
& compliance
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Specialization in Genomic Testing
Specialties: gene mutation test, gene expression monitoring, genotyping, copy number analysis and next-generation sequencing
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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
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Highest-Quality Certifications
GMP-compliant facility with CLIA and ISO 13485 certifications