ExiStation Molecular Diagnostic Platform | Bioneer Corporation

General Description
The ExiStation Molecular Diagnostic Platform is a semi-automated system that provides sample preparation and real-time diagnostics for a variety of clinical sample types and tests. The system allows for simultaneous parallel analysis of up to 6 different samples types and tests in under 4 hours making it the highest throughput system available.

Technical Description
The ExiStation consists of 3 x ExiPrep 16 Dx systems, and ExiSpin and an Exicycler 96. The ExiPrep systems are sample prep devices capable of purifying DNA and RNA from a wide range of clinical samples and uses proprietary spherical magnetic nano-particles. Once the sample is purified, the ExiPrep 16 Dx will also set up the diagnostic qPCR reaction which is then taken to the ExiSpin. The ExiSpin is a combination centrifuge/vortexer that is used to mix and spin the reactions in a uniform manner ensuring world class reproducibility of the kits. Finally, after mixing and spinning in the ExiSpin, the samples are placed in the Exicycler 96 Real-Time thermal cycler. The Exicycler uses a peltier based thermal block and has 5-color optics with a 16 bit 2-d CCD camera for detection.

Evaluation Criteria

THROUGHPUT:

Between 60 minutes and 8 hours for detection
Multiple samples, multiple tests/sample per run
49-96 samples every 2 hours
The system or device is currently semi-automated
Device or system is intended for multiple detection assays
2 solutions, buffer, eluents, and/or reagents
5 or more components
Less than 5 minutes is required for set-up
1-2 steps are required for detection

LOGISTICS:

An afternoon of training and some technical skills required
Approximately the size of a carry-on luggage suitcase
More than 50 kg
Wired connections are available
System or device has 110V electrical requirement

OPERATIONS:

Can be used from 25°C to 37°C
Components must be stored at room temperature (27°C)
Performance is not influenced by relative humidity
Between 1 to 3 years shelf life
5-10 years expected life
Results can be viewed in real-time
The system or device is currently fully autonomous
The system software is closed and not available for modification
The system hardware is closed and not available for modification

DETECTION:

Possible the system could receive 510K clearance, no current efforts at this time
Possible the system could receive FDA approval, no current efforts at this time
Less than 250 µL
Excellent specificity. System has occasional false alarms under certain conditions (<2%)
1-100 CFU per mL
1-100 PFU per mL
Fully automated spore lysis

Tier Selection