Press release

DiaCarta and MIODx Join Forces to Develop a Diagnostic Test to Predict Patient Responses to Immunotherapy

Apr 16, 2018 | Press Releases

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.

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DiaCarta Receives Accreditation by the College of American Pathologists (CAP)

DiaCarta, Ltd. (“DiaCarta”), a novel molecular diagnostic test developer for cancer and infectious diseases, today announced that it has received accreditation by the College of American Pathologists (CAP) for its CLIA certified lab. This accreditation is awarded to facilities that meet the high standards of quality, accuracy, and consistency in laboratory services required by CAP and underscores DiaCarta’s leadership and commitment to excellence.

DiaCarta Receives U.S. FDA Emergency Use Authorization for its Monkeypox Test Kit

DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics company, today announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for its QuantiVirus™ MPXV test, which is a PCR test for the qualitative detection of DNA from monkeypox virus (MPXV) in lesion swabs collected from individuals suspected of monkeypox infection.