Molecular Diagnostic Platform

Our Role

  • Our goal was to produce a fully automated, simple to use MDx instrument and its sample processing cartridge from design through pilot production units.

Project

  • Diagnostic Equipment
  • Devices
  • Molecular Diagnostics

Client

N/A

Features & Accomplishments

A client approached Gener8 to develop a flexible clinical molecular diagnostic (MDx) platform that can detect different oncogenes from formalin-fixed paraffin-embedded (FFPE) samples using oncogene panel specific cartridges to be used in hospitals to provide fast and actionable clinical results. The platform will fully automate the end-to-end workflow starting from patient sample processing through generating analysis reports.

Challenges
Since the entire sample processing workflow will be performed in a self-contained cartridge, one of the challenges is the management of the co-development efforts of the instrument and cartridge.

Methods
Our expertise in both engineering and cartridge consumable design worked together to seamlessly deliver a fully automated MDx instrument that can perform the entire patient sample processing workflow with a precise interface to the sample processing cartridges. The solution included the following and more:
• Optical component for multi-channel qPCR detection
• Precise optical alignment to the cartridge
• Microfluidic controls
• Thermocycling Hardware
• Sonication station
• Magnetic bead-based nucleic acid purification station

Outcome
Gener8 understands the challenges of designing, developing, and manufacturing complex molecular diagnostic instruments.
We turned around the preliminary instrument and cartridge design quickly with staff experienced with nucleic acid amplification test (NAAT) based instrument development. The design was successfully transferred into pilot production with a dedicated onsite New Product Introduction (NPI) team so our client could reach their commercialization goal.