DiaCarta, Inc Closes $8 Million Series A Round for Development and Commercialization of Precision Molecular Diagnostics
DiaCarta, Inc is a privately-held biotechnology company raised $8 million in Series A financing from BVCF (BioVeda China Fund). Proceeds from Series A financing will be used to expand the product portfolio and support global commercialization. Dr. Weixin Xu of BVCF will join DiaCarta board of directors.
DiaCarta has CE/IVD assays for highly sensitive mutation detection in EGFR, KRAS, NRAS, BRAF, PIK3CA and JAK-2. QClamp™ mutation detection assays utilize a novel xeno-nucleic acid (XNA) clamping technology to suppress amplification of wild-type DNA allowing selective amplification of mutant DNAs in real-time PCR. Mutant DNAs present at less than 0.1% can be detected. The sensitivity and specificity of QClamp™ make it superior to NGS and ddPCR.
DiaCarta’s QuantiVirus® HPV E6/E7 mRNA tests detect HPV E6/E7 mRNA in cervical and oral cancer. Assays are based on branched DNA signal amplification technology, performed without RNA purification or RT-PCR and do not require a clean room environment. Assays are CFDA (Chinese FDA) and CE/IVD cleared.
“We look forward to supporting the parallel development of precision molecular diagnostic tests in the US and China. These novel technologies offer an attractive option to address the growing needs of personalized medicine and companion diagnostics.” said Zhi Yang, general partner at BVCF.
“We seek to be at the forefront in the development of non-invasive tests for detection and monitoring of tumor mutations in human body fluids. We look forward to expanding our product offerings and seeking regulatory approvals in the EU, China and eventually the US.” said Aiguo Zhang, Ph.D., President & CEO of DiaCarta, Inc.
BVCF (http://bvcf.com/, formally known as BioVeda China Fund) is a growth capital focused private equity fund specializing in China Life Sciences and Healthcare industry. Headquartered in Shanghai, BVCF primarily focuses on equity investments in growth-stage companies in the field of Pharmaceuticals, Biotechnology, Traditional Chinese Medicine, Medical Devices, Healthcare Services, Industrial and Environmental Biotechnology.
About DiaCarta, Inc.
DiaCarta is a leading Translational Genomics and Molecular Diagnostics company located in the San Francisco Bay area, pioneering novel molecular diagnostics technologies.
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.