Bionano Genomics obtains class I registrations from China’s NMPA

Bionano Genomics announced that its Chinese original equipment manufacturing, OEM, partner, Beijing Genome Precision Technology, BGPT,, a comprehensive molecular diagnostics company, has obtained reagent class I registrations from China’s National Medical Products Administration. NMPA, for Bionano’s DNA extraction kit and labeling products. NMPA issued three approvals to BGPT: two for Bionano’s direct label and stain DNA labeling kits and one for Bionano’s bone marrow aspirate DNA isolation kit. The NMPA registrations for Bionano’s products enable these reagents to be used for in vitro diagnostics in China. Eventually, they are expected to help sales and placements of both Bionano’s instruments and reagents in China. Erik Holmlin, PhD, president and chief executive officer of Bionano, commented, "We are really excited to see our OEM partner BGPT receive NMPA approval for our reagents, which can help make optical genome mapping available in China. We look forward to seeing continued progress in the Chinese market."