DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy
MIODx and DiaCarta announced today that they have entered into an agreement for the development of a diagnostic test for immunotherapy. The test is based on MIODx’s ClonoMap™ immune sequencing platform, and is designed to predict patient response to immunotherapy, which will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China. The product will be manufactured at DiaCarta’s ISO 13485 certified GMP manufacturing facility. Immunotherapies have shown great promise in the treatment of cancer, but only some patients respond to therapy. “With this agreement, MIODx’s ClonoMap™ technology will complement DiaCarta’s well-established business in molecular diagnostics, and advance a much needed test for patients undergoing immunotherapy,” said Aiguo (Adam) Zhang, Ph.D., Founder and CEO of DiaCarta.
“With the well-established CLIA and ISO manufacturing facility at DiaCarta, also the experienced IVD team and sales channels in the U.S., Europe and China, we are able to speed up our MIODx’s ClonoMap™ technology to the global market, especially the huge market potential in China. We are very eager to see the impact of the test to benefit patients undergoing immunotherapy,” said M. Allen Northrup, Ph.D., CEO of MIODx.
DiaCarta is a translational genomics and personalized diagnostics company based in Richmond, California with significant business operations in China. DiaCarta provides highly sensitive and advanced XNA technologies that will improve the way molecular diagnostics and translational genomics impact healthcare treatment plans and the well-being of individuals around the world. With over 20,000 square feet dedicated to a GMP-compliant lab space as well as CLIA and ISO 13485 certifications, DiaCarta is changing the landscape of molecular diagnostics.
MIODx is an early-stage immunogenomics company based in San Jose, California. The company has developed the ClonoMap™ TCR and BCR sequencing platform that can be used to design diagnostic tests, discover new immunotherapies, or interrogate a person’s immune system. The company is applying the platform to develop diagnostic tests in oncology to help patients have a medically improved outcome.
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.