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.
According to the recent FDA SARS-CoV-2 Reference Panel Comparative Data released on September 15, among all the FDA EUA tests with returned results, DiaCarta’s QuantiVirusTM SARS-CoV-2 Test and QuantiVirus™ SARS-CoV-2 Multiplex Test both rank within the top 3 for product sensitivity.
DiaCarta’s QuantiVirus™ SARS-CoV-2 Multiplex Test ranks among the top 10 kits in terms of low limit of detection (LoD). DiaCarta is the top 6 company, after Perkin Elmer, Roche, Quest, RTA and BD Biosciences.
DiaCarta Receives Regulatory COFEPRIS Approval in Mexico & ICMR Approval in India for its FDA EUA Approved QuantiVirus™ SARS-CoV-2 Test
DiaCarta Inc., a precision molecular diagnostics company with a unique, patented XNA technology platform for the development of novel liquid biopsy tests, announced today that its QuantiVirus™ SARS-CoV-2 test has been approved for distribution in Mexico.
DiaCarta SARS-CoV-2 Test Detecting 3 Viral Genes Receives US FDA Emergency Use Authorization & Test Manufacturing Expanded to 500K COVID-19 Tests/Week
DiaCarta Inc, a precision molecular diagnostic company in CA, announced Thursday the US FDA granted Emergency Use Authorization for DiaCarta’s proprietary QuantiVirus™ PCR diagnostic (Dx) test specifically detecting three different genes of SARS-CoV-2, the virus causing the COVID-19 pandemic. DiaCarta recently expanded manufacturing capacity to 500,000 tests per week and is planning to expand to even larger (4x) scale manufacturing to meet the increasing demand for PCR tests to monitor COVID-19.
DiaCarta Inc. has filed for EUA with the FDA and has received CE mark for its highly sensitive QuantiVirus™ SARS-CoV-2 Test Kit
DiaCarta Inc., a precision molecular diagnostic company, announced today that it has filed for Emergency Use Authorization (EUA) with the US FDA for its QuantiVirus™ SARS-CoV-2 test and has validated the COVID-19 diagnostic test in its own CLIA certified lab in Richmond, CA to provide testing services for healthcare providers and patients. DiaCarta recently received Conformitè Europëenne (CE) Mark for its product.