Headquartered in Richmond, California with an ISO 13485-certified facility, DiaCarta develops, manufactures and markets cancer research and IVD products for precision molecular diagnostics. We specialize in genomic testing for biomarkers and offer clinical sample testing services in our CLIA-certified lab. We have also established our business operations and clinical service lab in Shanghai and Nanjing, China, respectively. QClamp® and OptiSeq™ are xeno nucleic acid (XNA) based technologies that enable highly sensitive detection of actionable mutations using qPCR and next-generation sequencing (NGS) platforms, respectively, for liquid biopsy and other traditionally challenging specimens. Other XNA applications include CRISPR/Cas9 gene-editing event screening and adapter dimer removal for NGS library preparation.
OptiSeqTM NGS platform is a game changer that leverages the power of xeno nucleic acid (XNA) technology to detect genetic mutations with ultra-sensitivity and accuracy in liquid biopsy and other challenging samples without deep sequencing. 500X OptiSeqTM reads (with XNA) are equivalent to 50,000X reads without XNA. The platform provides a complete sample-to-insight solution. We offer the following panels and more: Pan-cancer, breast, lung, prostate, colon and prostate.
End-to-end solutions consist of i) sample/library preparation, ii) NGS sequencing, iii) bioinformatics analysis, iv) reporting. NGS applications include whole genome sequencing, exome sequencing, mRNA sequencing, small RNA (miRNA, shRNA) sequencing, ChIP sequencing, amplicon sequencing, 16S metagenomics and disease panel sequencing. In addition to nucleic acids from cell lines, tissues and FFPE samples, we are specialized to sequence and analyze DNA/RNA from liquid biopsy samples.
End-to-end capabilities that include genomic profiling, cytokine assay development and comprehensive CAR-T services. For example, the QClamp® XNA-PCR platform enables the screening of human antibody libraries and detection of rare actionable mutations in oncogenes such as NRAS and EGFR VIII as well as CD19-specific chimeric antigen receptor. The platform also consists of single chain variable fragment (scFV) design, lentivirus and CAR-T cell manufacturing in GMP facility with ISO 13485 certification, CAR expression validation, cytokine induction and real-time cytotoxicity assay and genomic profiling in GLP and CLIA lab settings.
Services are performed in our CLIA-certified lab. Clinical testing of liquid biopsy, FFPE tissue and other traditionally challenging samples for biomarker analysis on genomic analysis platforms. e.g. Ultra-sensitive QClamp® qPCR-based assay to detect BRAF V600E mutant with < 0.1% allelic frequency; QFusionTM qPCR-based assay to detect EML4-ALK and KIF5B-ALK fusion gene variants with 1% allelic frequency; FISH assay for EML4-ALK fusion gene detection.
Our CDx solutions are designed to accelerate cancer drug development and approval with services including i) design and acquisition of reagents; ii) development of research use only (RUO) assay; iii) analytical verification and validation, iv) manufacturing and validation of lab-developed test (LDT) assay, v) IVD development. All services are performed in our CLIA- and ISO 13485-certified facility. Our clinical services labs are located in United States and China.
A convenient and rapid method for i) mutant screening after CRISPR/Cas9 edited genomic DNA sequences; ii) screening of large numbers of edited cell populations to determine the frequency of edits; iii) detection of both HDR and NHEJ gene edits. The method involves a simple real-time PCR assay that uses primers to amplify a region 80-100 bp that span the edited locus. No laborious gel electrophoresis required, and the method works when T7 endo and Surveyor methods fail.
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