NEW YORK – Bionano Genomics said on Monday that its Chinese original equipment manufacturing (OEM) partner, A-smart MedTech, has secured reagent class I registrations from China's National Medical Products Administration (NMPA) for the company's DNA extraction and labeling products.
With the NMPA approval, Bionano said the G2 direct label and stain (DLS) DNA labeling kit and the G2 SP bone marrow aspirate (BMA) DNA isolation kit can now be sold for in vitro diagnostic use for reproductive health in independent clinical laboratories and hospitals in China.
A-smart, an assisted reproductive technology company, is Bionano's second OEM partner in China, where the San Diego-based optical genome mapping (OGM) firm is heavily eyeing the clinical market. Bionano previously formed an OEM partnership with Beijing Genome Precision Technology (BGPT), which has obtained NMPA reagent class I registrations for Bionano's DNA extraction kit and labeling products.
"We believe the expansion of NMPA approvals can help make OGM available to China's large population seeking support for reproductive health, including genetic analysis of people considering pregnancy, pre-implantation analysis of in vitro fertilized embryos, and other prenatal and postnatal genome analyses, which we believe will help Bionano grow sales of the company's OGM systems in China," Bionano President and CEO Erik Holmlin said in a statement.