BD Molecular Diagnostics

There are a significant number of labs that perform in-house developed molecular assays or “User Defined Protocols” (UDPs) worldwide. The vast majority of UDPs require time intensive hands-on procedures. Assay processing typically involves discrete extraction, amplification and detection procedures on two or more platforms over the course of several hours to several days.

Challenging validation processes and lack of flexibility of these platforms force labs offering multiple UDPs to purchase and maintain numerous pieces of equipment which remain underutilized due to their limited application. Additionally, many labs are forced to send out tests that are too complex or low volume to run in-house, and lack a standardized platform with the ease-of-use needed for them to be able to process certain assays in house.

The BD MAX™ System is unique to the market as it can automate the sample lysis, extraction, amplification and detection processes. The objective of the BD MAX™ Open System Reagent Suite is to provide an easy-to-use, automated solution for labs performing UDPs, with the flexibility to respond to evolving needs. BD provides consolidated testing on a single platform with a simplified workflow by providing extraction of DNA, RNA and total nucleic acid on the same system. This is combined with the freedom to utilize a wide variety of master mixes, including BD’s MMK products.  Finally, the BD MAX™ System allows laboratories that were formally outsourcing testing to now perform in-house due to the ease-of-use of the system, reduction in labs costs and time-to-result for those assays.

BD MAX™ ExK Extraction Reagents

Automated extraction of DNA or Total Nucleic Acid from a wide range of sample types on the same system:

  • ExK DNA-1 Plasma, Serum, Neat Urine
  • ExK DNA-2 Cerebral Spinal Fluid, Dry Swabs
  • ExK DNA-3 Swabs in Universal Transport Media, Urine
  • ExK DNA-4 Stool
  • ExK TNA-2 Cerebral Spinal Fluid
  • ExK TNA-3 Swabs in Universal Transport Media

**The BD MAX System is cleared or approved by the FDA only when used with BD MAX IVD assays which have been cleared or approved by the FDA. IVD assays, research use only (RUO) assays and user-defined protocols (UDP) cannot be combined in the same rack.