Becton Dickinson (BD) Diagnostics is teaming up with U.K.-based Lab21 to develop a molecular diagnostic assay for detecting Aspergillus fungal infections, on the recently launched, fully automated BD MAX™ molecular testing system. BD says the collaboration means there are now 14 assays in development for the BD MAX platform.
“Our goal is to make the BD MAX system an indispensible tool in clinical laboratories by providing them with an ever-expanding test menu,” remarks Tom Polen, president of BD Diagnostics’ diagnostic systems division. The firm suggests the Aspergillus test will significantly speed treatment decision making. “The potential to detect Aspergillus in blood using real-time PCR is a topic of great interest to clinicians since it offers faster, more sensitive, and more accurate diagnostic and screening strategies for the early and definitive detection of aspergillosis,” adds Graham Mullis, Lab21 CEO.
Molecular diagnostics firm Lab21 offers oncology and infectious disease molecular diagnostics services to clinicians and the pharmaceutical industry, and is building a pipeline of molecular assays for commercialization and for use in its own clinical laboratories, together with a range of infectious disease test for blood screening. In May the firm acquired University of Manchester spin-out Myconostica, a molecular diagnostics firm specialized in the development of real-time molecular diagnostics for life-threatening fungal infections.
BD’s BD MAX system is a next-generation platform for molecular testing that automates cell lysis, nucleic acid extraction, PCR set-up, amplification, and detection. Launched on the U.S. market in May, the system is the first fully automated, benchtop system designed to perform a broad range of molecular tests including IVD assays, user-defined protocols, and life science research assays, BD claims.
Also in May, the firm teamed up with Belgium-based Diagenode to develop at least seven CE-marked molecular diagnostic tests for the BD MAX. Initial assays will include a respiratory panel, two panels for the diagnosis of virus- and parasite-based gastrointestinal infections, and a panel for the differential diagnosis of meningitis.
The first FDA-approved assay for the system, BD MAX GBS (group B streptococci), has been developed for the direct detection of GBS DNA in Lim broth cultures from swab specimens taken from pregnant women. BD has in addition developed a range of open system reagents for the BD MAX system, enabling laboratories to standardize and automate user defined protocols for multiple analytes and targets. Sample lysis and extraction only protocols as well as PCR only protocols can also be performed, BD notes.