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DiaCarta Clinical Services Laboratory Receives CLIA Certification

NEW YORK (GenomeWeb) – Molecular diagnostics developer DiaCarta announced today that its DiaCarta Clinical Services Laboratory has successfully passed the State of California survey under the Clinical Laboratory Improvement Amendments of 1988.

The lab now has permission to begin offering patient and clinical testing services for its QClamp-based molecular diagnostic. QClamp screens for tumor oncogenic driver and resistance mutations in tumor DNA derived from cancer patients.

The lab is located in Richmond, California, the company said, and specializes in patient testing and clinical trial services for gene mutation and gene expression monitoring, genotyping, and copy number analysis, as well as other molecular diagnostic tests. QClamp utilizes a sequence-specific xeno-nucleic acid clamp that suppresses PCR amplification on wild-type DNA and allows selective amplification of only the mutant template.

"We are very excited about the new addition of CLIA-certified clinical laboratory testing to our suite of product offerings," said Founder and CEO Aiguo Zhang in a statement. "Our CLIA certification is an important regulatory milestone and demonstrates our commitment to quality laboratory testing to provide accurate, reliable, and timely test results."

The company received a CE IVD mark for several of its QClamp line of real-time PCR-based mutation detection kits in February 2014.