NEW YORK – Bionano Genomics said on Thursday that its Chinese original equipment manufacturing (OEM) partner, Ecobono, has attained reagent class I registration from China's National Medical Products Administration (NMPA) for the company's DNA extraction product.
With the NMPA approval, Bionano said its SP-G2 DNA isolation kit can now be sold for in vitro diagnostic use in independent clinical laboratories and hospitals in China.
A distribution company focused on reproductive health products, Ecobono is Bionano’s third OEM partner in China, after A-smart MedTech and Beijing Genome Precision Technology (BGPT), which have helped Bionano obtain NMPA approvals for several other DNA labeling and isolation kits.
"We are very pleased to work with Bionano on the IVD registration of the Class I reagents," Ecobono CEO Wenli Wang said in a statement. "This approval is the first milestone of our partnership. We look forward to more potential milestones for the registration of additional reagents and instruments in the future."