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.
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 Announces That the Oncuria® Bladder Cancer Tests Receive Medicare Coverage Effective January 1, 2024
DiaCarta proudly announced that the Oncuria® Bladder Cancer Tests, developed by Nonagen Bioscience and validated by DiaCarta as a Lab Developed Test (LDT), at its CAP-accredited and CLIA-certified laboratory, have received Medicare coverage effective January 1, 2024.
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.
DiaCarta’s RadTox™ Test to Monitor Tumor Response Receives Medicare Coverage
DiaCarta, a leading molecular diagnostics company personalizing patient care through liquid biopsy, proudly announced that its revolutionary RadTox™ test, designed for tumor response monitoring, is now eligible for reimbursement from Medicare, effective January 1, 2024.
DiaCarta Launches OTC at Home Fecal Occult Blood Test to Complement its ColoScape™ Test
DiaCarta announced today that DiaCarta received US FDA 510(k) clearance for it’s over the counter (OTC) at home iColon Fecal Occult Blood Test (FOBT) that enables early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer.