Press release

DiaCarta Inc. Launches Ultra-Sensitive TaqMan-Based qPCR Assays for Cancer Gene Mutation Detection

Oct 29, 2018 | Press Releases

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 >

ABOUT DIACARTA

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.

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Florida Selects DiaCarta’s cfDNA Test (RadTox™) for Statewide Use to Detect Early Response of Cancer Treatment

DiaCarta, a leading molecular diagnostics company specializing in personalized patient care through liquid biopsy, proudly announced that Florida Health Department selected “using plasma DNA concentration (DiaCarta’s RadTox™ test) for early detection of treatment response and resistance” through the Casey DeSantis Florida Cancer Innovation Fund. This fund supports deployment of the RadTox™ test throughout the State of Florida to be performed between Radiotherapy or Chemotherapy doses for real time detection of treatment response or resistance. The results will be as a real time predictor of imaging data.

DiaCarta, Inc. and OncoAssure Ltd. Collaborate to Launch Prostate Cancer Lab Developed Test

DiaCarta, Inc. (“DiaCarta”), a pioneer in molecular diagnostic test development for cancer and infectious diseases, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company. The focus of the collaboration is to commercialize OncoAssure’s groundbreaking Prostate test which is designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring post-treatment.

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