All laboratory testing (except research) performed on humans in the U.S is required to be conducted under Clinical Laboratory Improvement Amendments (CLIA), regulated by the Centers for Medicare & Medicaid Services (CMS) regulates. 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.
Clinical Test Services
OptiSeq™ Pan-Cancer Panel (65 Genes)
DiaCarta offers a sample-to-report OptiSeq™ Targeted Sequencing cancer diagnostic service at its state-of-art CLIA certified facility. The liquid biopsy/FFPE sample prep workflow provides clients with fast turnaround time and accurate VAF detection process.
QClamp® Gene Mutation Detection Tests
Including KRAS, NRAS, EGFR, BRAF, JAK and PIK3CA mutation detection tests.
Cancer Gene Panels
Including colon cancer panel (BRAF, NRAS and KRAS) and lung cancer panel (EGFR, KRAS and ALK).
Fusion Gene Test
Including QFusion™ EML4-ALK and KIF5B-ALK Fusion Gene Detection Kit.
Settings for Global Trials
gLOBAL CLINICAL OPERAIONS
CLIA labs in Both 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. Detects reliably 0.1% to 0.5% mutant DNA out of wild-type DNA for targeted mutations
GMP-compliant facility with CLIA and ISO 13485 certifications