DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc., a precision diagnostic company and leading developer of products for nucleic acid-based detection assays, announced today that it has received a $2 million National Cancer Institute (NCI) Small Business Innovation Research (SBIR) contract to continue development of its RadTox™ cfDNA radiation therapy toxicity monitoring test kit for cancer patients.
While radiation is required by 70
“This will be a breakthrough ‘first-in-class’ IVD test in the field of radiation therapy and one of the first cfDNA tests to be supported by the NCI for real-time detection of normal tissue responses to radiation,” commented Aiguo Zhang, Ph.D., Founder and CEO of DiaCarta, Inc. “We are therefore delighted to have been awarded this contract following successful completion of the $300,000 SBIR Phase I contract in June of this year.”
DiaCarta’s RadTox™ cfDNA Test, a platform diagnostic that monitors circulating cell-free DNA (cfDNA) in patient plasma during radiation therapy, runs on either luminometers or bead-based instrumentation found in many clinical reference laboratories and testing
DiaCarta has been invited to present RadTox™ cfDNA Test at the BIO Investor Forum in San Francisco on October 17-18, 2018, as part of the company’s commitment to a partnering and co-development strategy for the program.
“We are fulfilling an unmet medical need in cancer radiation therapy by enabling the direct monitoring of side effect severity and
Super branched DNA (SuperbDNA™) hybridization technology is a widely used signal amplification clinical platform to quantitatively detect specific nucleic acid sequences directly from the source without the need for DNA/RNA purification or RT-PCR. With a wide dynamic range, bDNA is sensitive enough to reliably detect very few target molecules using DiaCarta’s kits and reagents formatted on a luminometer or bead-based platform. DiaCarta’s SuperbDNA™ technology offers sensitivity for detection of over 4,000 target genes.
DiaCarta, a translational genomics and personalized diagnostics company based in Richmond, California, was established in 2011 to provide highly sensitive and advanced technologies that will improve the way molecular diagnostics and translational genomics impact healthcare treatment plans and the well-being of individuals around the world. DiaCarta offers a range of testing services, from single-gene QClamp® qPCR tests to its OptiSeq™ XNA-NGS panels. The company is well positioned as a leader in the new ‘liquid biopsy’ IVD (in vitro diagnostic) field with high-precision detection of cfDNA. DiaCarta is ISO13485 certified and manufactures IVD kits under
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.