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DiaCarta Clinical Services Laboratory Receives CLIA Certification

by | Mar 28, 2016 | Press Releases

DiaCarta Inc. today announced that DiaCarta Clinical Services Laboratory (DCSL) successfully passed the State of California survey under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The State of California inspector gave DCSL permission to begin offering QClamp-based molecular diagnostic patient and clinical trial testing services.

The DiaCarta-owned and -operated laboratories, both in Richmond, California, and Nanjing, China, enable clinical and research laboratories, as well as diagnostic and pharmaceutical companies, to incorporate complex molecular tests into clinical practice. The CLIA certification ensures that all of its processes are standardized to consistently meet federal and Clinical Laboratory Standards Institute (CLSI) guidelines for accuracy, precision, sensitivity, calibration and control. In addition, all of the DCSL assays have been validated for clinical applications to ensure reproducible results.

Located in Richmond, California, DCSL is a facility of over 16,000 square feet. The laboratory 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. The company is dedicated to the science of rapid, highly sensitive detection technologies and diagnostic solutions for healthcare that positively impact treatment plans and improve the wellbeing of individuals around the world. QClamp®, a revolutionary new way to screen for somatic mutations in cancer genes, utilizes a sequence-specific xeno-nucleic acid (XNA) clamp that suppresses PCR amplification on wild-type DNA template and allows selective amplification of only mutant template. With its detection sensitivity below 0.1%, QClamp® is ideal for a variety of samples including FFPE tissue, liquid biopsy and traditionally challenging cytology specimens. QClamp® on next-generation sequencing (NGS), the OptiSeq™ platform, can implement mutant DNA target enrichment to detect very low copy mutant numbers that are not possible by conventional NGS protocols.

“We are very excited about the new addition of CLIA-certified clinical laboratory testing to our suite of product offerings. Our CLIA certification is an important regulatory milestone and demonstrates our commitment to quality laboratory testing to provide accurate, reliable and timely test results,” said Dr. Aiguo Zhang, Founder and CEO of DiaCarta. “With our Independent Clinical Service Lab also in Nanjing, China, we are well positioned to become a key companion diagnostic partner with pharmaceutical companies for global clinical trials of novel targeted therapies.”

About DiaCarta Inc.
DiaCarta is a translational genomics and personalized diagnostics company headquartered in Richmond, California with business and clinical operations in Shanghai and Nanjing, China, respectively. We are dedicated to the science of rapid and highly sensitive detection technologies and diagnostic solutions for healthcare that positively impact treatment plans and improve the well-being of individuals around the world. QClamp®, a revolutionary new way to screen for tumor oncogenic driver and resistance mutations in tumor DNA derived from cancer patients, utilizes a sequence-specific xeno-nucleic acid (XNA) clamp that suppresses PCR amplification on wild-type DNA template and allows selective amplification of only mutant template with detection sensitivity below 0.1% for a variety of samples including FFPE tissue, liquid biopsy and traditionally challenging cytology specimens. The QClamp® XNA-PCR technology has also been applied for mutant DNA target enrichment on our OptiSeq™ next-generation sequencing platform. QuantiVirus™ HPV cervical cancer and DigiPlex™ genotyping tests are the products powered by SuperbDNA™ and multiplex bar-coding technology platforms, respectively. To learn more, visit https://www.diacarta.com.

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DiaCarta Receives CE/IVD for its New COVID 19 Test that Identifies Delta Plus and New Variants

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced that its new QuantiVirus™ SARS-CoV-2 Variant Detection Test received the CE/IVD marking and therefore, can now be commercialized within the EU and rest of the world. This new test screens for the SARS-CoV-2 virus and simultaneously identifies and differentiates all the new mutating COVID 19 variants including the Alpha (UK), Beta (S. Africa), Gamma (Brazil), Delta (India), Delta Plus (India), Epsilon (California) and the Kappa (India) variants.

DiaCarta’s Novel XNA Technology Rapidly Detects Raging New SARS-CoV-2 Variants

DiaCarta Inc., a precision molecular diagnostics company and leading developer of novel oncology tests using liquid biopsy today announced the publication of a study entitled “A Rapid SARS-CoV-2 Variant Detection by Molecular-Clamping Based RT-qPCR” in MedRxiV that demonstrates the enhanced sensitivity and specificity using its proprietary XNA based Molecular Clamping Technology that uses innovative synthetic Xenonucleic acid molecular oligomers (XNA) that hybridize with target wild-type DNA sequences, acting as molecular clamps, to enable the accurate amplification of mutant sequences only, using quantitative real-time polymerase chain reactions (qPCR).

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