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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.

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-the-art CLIA-certified facility. The liquid biopsy/FFPE sample prep workflow provides clients with fast turnaround time and accurate VAF detection process.

Research service

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


CLIA labs in both the U.S. and China. Both sites use the same quality system 
& compliance

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

Highest-Quality Certifications

GMP-compliant facility with CLIA and ISO 13485 certifications

Need Help?

Call us: +1 (800) 246-8878

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