DiaCarta Introduces QFusion™ Single-Tube qPCR Assay for ALK Fusion Gene Detection
DiaCarta today announced the introduction of QFusion™ RT-qPCR assay, a new product for the comprehensive, rapid and reliable detection of ALK fusion gene variants. The assay enables users to detect ten EML4-ALK and three KIF5B-ALK fusion gene variants in a single tube of multiplexed reactions with only 50 ng of RNA from FFPE samples in approximately 1.5 hours. It addresses critical issues in fluorescence in situ hybridization (FISH), the “gold standard” technique in fusion gene analysis, by eliminating objective interpretations of chromosomal break-apart patterns and reducing turnaround time by more than ten-fold.
Joining QClamp® EGFR and KRAS gene mutation detection kits in the DiaCarta’s lung cancer panel, the QFusion™ assay provides researchers and pathologists with a new tool to expand and accelerate their research in non-small cell lung cancer (NSCLC). The assay is the only commercial qPCR kit on the market that detects both EML4-ALK and KIF5B-ALK fusion gene variants, covering 95% of EML4-ALK and 90% KIF5B-ALK variants found in the COSMIC database for NSCLC. QFusion™ ALK generates highly specific results and accurately detects as low as 50 fusion templates in each reaction.
“I am excited about the launch of our QFusion™ ALK fusion gene detection assay. It is a best in class product that provides comprehensive, rapid and robust detection of not only the widely studied EML4-ALK but also the novel KIF5B-ALK fusion genes. Our one-tube assay is an alternative to the laborious slide-based ALK fusion gene assays, especially FISH, and it is designed to improve the quality and productivity of NSCLC research in many labs where real-time PCR machines are routinely used,” said Michael Powell, Ph.D., Chief Scientific Officer of DiaCarta. “As an innovator in precision molecular diagnostics, DiaCarta is uniquely positioned to deliver advanced solutions for cancer research and diagnostic applications. Among a suite of tests that we are planning to launch within the next year, QFusionTM ALK is one of them, and it has been designed and developed in our CLIA- and ISO 13485-certified facility.”
About DiaCarta, Inc.
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. To learn more, visit https://www.diacarta.com.
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.