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.
DiaCarta announced that it is launching a new suite of CE-IVD marked highly sensitive hydrolysis probe (TaqMan-qPCR) based QClamp® assays for detection of common cancer mutations in genes, such as KRAS, NRAS, BRAF, EGFR, PIK3CA and JAK2, using tissue biopsy (FFPE) and liquid biopsy (cfDNA) samples.
DiaCarta, Inc., Awarded $2 Million NCI Contract to Pursue Regulatory Approval of Innovative Cancer Radiation Response Blood Test
DIACARTA, Inc. 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.
DiaCarta has been recognized as one of the Top 10 In-Vitro Diagnostic Technology Solution Providers 2018 by Med Tech Outlook Magazine. The positioning is based on an evaluation of DiaCarta’s specialty in genomic testing for biomarkers, personalized diagnostics and clinical sample testing service provided in their CLIA-certified lab.
DiaCarta today announced that it has signed a distribution agreement with Arrow Diagnostics. Under the agreement, Arrow Diagnostics becomes sole distributor of ColoScape™ a multigene biomarker TaqMan qPCR in vitro diagnostic (CE-IVD) test in Italy, San Marino & Vatican City.
CIO Applications has chosen DiaCarta as one of the Top 25 Life Sciences Technology Vendors 2018. The positioning is based on an evaluation of DiaCarta’s specialty in personalized diagnostics, translational genomics and clinical sample testing services provided in both US and China.