Thermo Fisher Scientific and HEALTH BioMed have announced a collaboration to support HBM’s development of molecular diagnostic (MDx) kits for infectious disease and pharmacogenomics screening to serve the China market. Under the terms of a strategic agreement, HBM will submit all kits it develops on the Applied Biosystems 3500Dx Capillary Electrophoresis (CE) platform through the appropriate regulatory process with the China Food and Drug Administration (CFDA) following successful validation.
“Our collaboration with Thermo Fisher Scientific will enable HBM to meet a critical need in the China market for a series of high accuracy kits designed to run on a single CE platform to improve human health outcomes,” said Jianwei Yu, Chairman and CEO of HEALTH BioMed. “Molecular diagnostics such as these can improve diagnosis and treatment strategies in hospital settings while also helping to decrease antibiotic abuse.”
HBM intends to leverage its CE-based Advanced Fragment Analysis (AFA) technology and reagents, which are currently CE-IVD-and cFDA-marked as is the ABI 3500Dx platform, to develop multiple assays under its SureX brand of multiplex kits. HBM’s current offering for human papillomavirus (HPV) screening, for example, is designed to target 25 high- and low-risk markers with high sensitivity, specificity and low hands-on-time. Development of its pharmacogenomics kits under the agreement will be designed to further support precision medicine initiatives in the country.
“As the world leader in serving science, we are proud to be an enabling partner to help HEALTH BioMed build its portfolio of molecular diagnostics designed to better manage human health in China,” said Mark Smedley, president of genetic sciences at Thermo Fisher. “We are committed to working with diagnostic partners around the world who share our vision to drive the era of precision medicine.”