DiaCarta Inc. Launches Ultra-Sensitive TaqMan-Based qPCR Assays for Cancer Gene Mutation Detection
DIACARTA Inc., a precision molecular diagnostics company headquartered in Richmond, California, today announced that it is launching a new suite of CE-IVD marked highly sensitive hydrolysis probe (TaqMan qPCR) based QClamp® assays for detection of common cancer mutations in genes, such as KRAS, NRAS, BRAF, EGFR, PIK3CA and JAK2, using tissue biopsy (FFPE) and liquid biopsy (cfDNA) samples. The tests are validated on standard real-time qPCR instruments including Thermo Fisher Scientific Quantstudio 5, Roche LightCycler® 480 and Bio-Rad CFX384. The analytical sensitivity ranges from 0.1 to 0.5% for variant allelic frequency, providing lower detection limit compared with competition due to application of DiaCarta’s proprietary XNA technology. The XNA technology selectively enriches mutant sequences while suppressing amplification of wild-type sequences, allowing identification of cancer gene mutations from small population of cells among large number of normal cells, thus making early cancer gene mutation detection possible.
High sensitivity detection of somatic cell gene mutations is not only critical for testing due to tumor tissue heterogeneity but also important for guidance in targeted therapy and monitoring of disease recurrence. DiaCarta’s highly innovative QClamp® TaqMan gene mutation tests are configured to work with DNA extracted from traditional formalin fixed paraffin embedded (FFPE) tumor biopsy samples as well as minimally invasive liquid biopsy plasma samples. LEARN MORE >
DiaCarta is a translational genomics and personalized diagnostics company based in Richmond, California with significant business operations in China. DiaCarta provides highly sensitive and advanced technologies to improve human health around the world. With over 20,000 square feet dedicated to a GMP-compliant lab space as well as CLIA and ISO 13485 certifications, DiaCarta is changing the landscape of molecular diagnostics.
DiaCarta offers research use and CE-IVD products and CLIA services for cancer gene mutation detection by leveraging different technology platforms, including single gene or small panel of genes using qPCR platform, multiple gene target detection using multiplex assays, and high-throughput next generation sequencing platforms powered by XNA technology or branched DNA technologies.
DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc. announced today that it has received a $2 million National Cancer Institute (NCI) Small Business Innovation Research (SBIR) contract to continue development of its RadTox™ cfDNA radiation therapy toxicity monitoring test kit for cancer patients.
DiaCarta has been recognized as one of the Top 10 In-Vitro Diagnostic Technology Solution Providers 2018 by Med Tech Outlook Magazine. The positioning is based on an evaluation of DiaCarta’s specialty in genomic testing for biomarkers, personalized diagnostics and clinical sample testing service provided in their CLIA-certified lab.
DiaCarta today announced that it has signed a distribution agreement with Arrow Diagnostics. Under the agreement, Arrow Diagnostics becomes sole distributor of ColoScape™ a multigene biomarker TaqMan qPCR in vitro diagnostic (CE-IVD) test in Italy, San Marino & Vatican City.
CIO Applications has chosen DiaCarta as one of the Top 25 Life Sciences Technology Vendors 2018. The positioning is based on an evaluation of DiaCarta’s specialty in personalized diagnostics, translational genomics and clinical sample testing services provided in both US and China.
DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy
MIODx and DiaCarta announced today that they have entered into an agreement for the development of a diagnostic test for immunotherapy. The test is based on MIODx’s ClonoMap™ immune sequencing platform, and is designed to predict patient response to immunotherapy, which will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China.