DiaCarta Inc. Launches QClamp™ Somatic Mutation Real-Time PCR Tests for KRAS, NRAS, EGFR, BRAF, PIK3CA and More Without DNA Extractions
DiaCarta is a new Translational Genomics and Molecular Diagnostics company located in the San Francisco Bay area and is pioneering novel molecular diagnostics technologies for detection of cancer biomarkers in human body fluids including saliva, blood and urine – so called ‘Liquid Biopsy’ in the field of Oncology, today announced it has launched its QClamp™ somatic mutation tests, highly sensitive and rapid tests for KRAS, NRAS, EGFR, BRAF, PIK3CA and more in 2 hours without DNA extraction.
QClamp™ is a revolutionary new way to screen for somatic mutations, which utilizes a sequence specific wild-type template xeno-nucleic acid “Clamp” (XNA) that suppresses PCR amplification of wild-type template DNA and allows selective PCR amplification of only mutant templates. This allows the detection of mutant DNA in the presence of a large excess of wild-type template from any type of sample including FFPE, needle biopsy, whole blood and urine. The tests take less than 2 hours from start to finish without DNA extraction using special Qzol direct PCR lysis buffer and can detect below 0.1% mutated DNA.
“Recent studies have demonstrated that DNA sequencing is one of the least sensitive methods for characterizing mutation with only 10-20% of mutated DNA detected,” said Dr. Michael Powell, CSO of DiaCarta. “It has become clear that most if not all tumors are polyclonal and heterogeneous. Consequently, tumor driver mutations may not be detectable using standard DNA sequencing methods. Our QClamp™ tests are super sensitive and rapid. You don’t need to invest hundreds of thousands of dollar for a fancy digital PCR or sequencing machine. Our tests can be run on all currently available real-time PCR machines and everything to perform the tests is included in the kits.”
“We are very excited to launch this new product line to meet the unmet market,” said Dr. Aiguo Zhang, founder and CEO of DiaCarta. “We have received overwhelming responses from the field and our tests are the best in the market to address the issues with somatic mutation testing in oncology personalized diagnostics. We are in the process of CE Mark applications and expect to receive them by end of this year.”
About DiaCarta Inc.
DiaCarta, based in Hayward, Calif., is developing and commercializing in vitro diagnostics for a wide range of diseases based on branched DNA (bDNA) Signal Amplification technology and QClamp™, proprietary technology platforms for gene quantification and somatic mutation tests. DiaCarta offers a suit of oncogene test and companion diagnostic development services including QuantiVirus® HPV E6/E7 mRNA for cervical cancer and QuantiVirus® HPV E6/E7 mRNA for head-neck cancer tests.
DiaCarta Helps Communities Scale Up Their MPOX Testing Efforts with Its Simple, Reliable, and FDA-EUA-Approved MPOX Testing Kits
DiaCarta, Inc., an experienced in-vitro diagnostics (IVD) company that provided COVID-19 testing kits during the global pandemic, has expanded its focus to mpox detection and the detection of other infectious diseases.
DiaCarta and Capstone Health Alliance Collaborate to Bring Revolutionary Diagnostic Tests to Enhance Patient Care
DiaCarta, Inc., a pioneer in developing innovative molecular technologies to transform patient care by providing effective precision diagnostics using liquid biopsy in cancer and infectious diseases has established a strategic collaboration with Capstone Health Alliance, one of the largest regional group purchasing organizations (GPO) in the US healthcare sector. This new collaboration brings together powerful technologies to enhance patient care.
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.