DiaCarta Obtains Exclusive License for Non-Invasive Early Detection Colon Cancer Test
DIACARTA INC. (“DIACARTA”) and UNIVERSITY OF POTSDAM (Germany) today announced that the parties have entered into an exclusive license agreement for the development and commercialization of non-invasive early detection of colon cancer from stool samples. University of Potsdam holds awarded patent “Method for Conducting Non-Invasive Early Detection of Colon Cancer/or of Colon Cancer Precursor Cells.” Under the terms of the agreement, DiaCarta will pay Potsdam an upfront payment plus additional payments based upon achievement of commercial milestones. DiaCarta will have exclusive rights to develop and commercialize the test globally.
Some key clinical groundwork has been established by the group to develop the non-invasive diagnostic test that could be used to screen for early colorectal cancer as well as precursor lesions by detecting cancer-initiating mutations associated with colorectal cancer, which was published in Cancer Prevention Research.
“DiaCarta’s XNA Clamping technology to block all the WT-DNA is the most promising tool for the non-invasive early detection of mutations, including from liquid biopsy,” said Dr. Bettina Scholtka, assistant professor at the University of Potsdam and inventor of the patent. “We are very pleased to partner with DiaCarta to accelerate worldwide development and commercialization of Non-Invasive Early Detection of Colon Cancer.”
“With this agreement, DiaCarta now can extend its QClamp® somatic mutation test product line targeting this unmet market,” said Aiguo Zhang, PhD, DiaCarta’s Founder and CEO. “We look forward to working with Dr. Bettina Scholtka and her team at University of Potsdam to move the unique colon cancer early detection program forward as quickly as possible.”
About DiaCarta Inc.
DiaCarta, is an innovative translational genomics and precision molecular diagnostics company located in the San Francisco Bay Area. QClamp® is a rapid, sensitive qPCR based platform for detection of somatic mutations in cancer genes. The technology can also used for mutant DNA enrichment for Sanger and NGS sequencing. HPV QuantiVirus® cervical and head-neck cancer tests are based on branched DNA technology, which allow detection of oncogenic E6/E7 mRNAs from 14 high-risk subtypes and genotyping of HPV 16 and 18, directly from samples without RNA purification and RT-PCR.
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.