Becton Dickinson’s BD Diagnostics business and Lab21 are to collaborate on the development of oncology assays for the automated BD Max™ benchtop molecular testing system. Under terms of the deal, which aims to generate the first personalized cancer diagnostics for the BD Max system, Lab21 will develop PCR assays for a series of oncology markers, which BD will manufacture and commercialize worldwide. Lab21 will initially focus on developing assays for KRAS and BRAF. The deal also includes the development of nucleic acid extraction procedures from formalin-fixed paraffin-embedded tissue. Lab21 and BD Diagnostics announced a collaboration in August last year to develop a molecular diagnostic assay for Aspergillus on the BD Max platform.
BD Diagnostics’ BD Max system automates the processes of cell lysis, nucleic acid extraction, PCR set-up, amplification, and detection. The FDA approved BD Max GBS (group B Streptococcus) assay developed as the first test for the system has been designed as an IVD to test for GBS DNA in Lim Broth cultures obtained from vaginal/rectal swab specimens from pregnant women. BD Diagnostics claims the assay is the only fully automated IVD method for PCR detection of GBS from Lim Broth cleared by the FDA.
The platform has been designed as an open system, and BD Diagnostics also offers BD Max Open System Reagents, including DNA and RNA extraction kits and consumables, which enables laboratories to standardize and automate user defined protocols for multiple analytes and targets, or carry out sample lysis and extraction only protocols, as well as PCR-only protocols.