BD Diagnostics is collaborating with Belgian IVD specialist Diagenode on the development of seven CE-marked molecular diagnostic tests for its BD Max™ system. Diagenode will lead initial development of the assays, including a respiratory panel, two panels for diagnosing virus- and parasite-based gastrointestinal infections, and a panel for the differential diagnosis of meningitis. BD says it plans to fully integrate the resulting IVD assays onto its BD Max platform and will ultimately take over responsibility for manufacturing and commercializing the tests globally.
Diagenode specializes in developing molecular diagnostics kits and technologies, and instruments and reagent systems for epigenetics research. “Our agreement with Diagenode represents the first milestone in BD’s strategy to make BD Max system an indispensible clinical laboratory tool,” comments the latter’s Tom Polen, president of diagnostic systems. “By collaborating with leading IVD developers, such as Diagenode, we intend to build a growing, content-rich menu of clinically relevant assays that will allow laboratories to meet ever-changing clinical needs.”
The BD Max System has been developed as a next-generation automated workstation for molecular testing. The firm claims the system simplifies workflow using unitized reagent strips, and completely automates all processes, from cell lysis and nucleic acid extraction, to PCR set-up, amplification and detection. The FDA approved BD Max GBS (group B streptococci) assay is designed for the rapid, automated detection of GBS DNA in Lim broth cultures obtained from vaginal/rectal swab specimens from antepartum pregnant women.