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.
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.