MX300 | CustomArray, Inc. | WMD Detector Selector

General Description
System for automating hybridization and reading of CustomArray DNA arrays, which can be used to detect organisms and genetic variants in laboratory settings. It is adaptable to any sample that has genetic material in it (either DNA or RNA).

Technical Description
Samples must be processed to extract nucleic acid material (using third-party kits), that material is then amplified (using a standard thermocycler), and the amplified material is put into the MX300 for hybridization to a DNA array and reading of results.

Evaluation Criteria

THROUGHPUT:

Between 60 minutes and 8 hours for detection
Between 60 minutes and 8 hours
Less than 32 samples every 2 hours
The system could be adapted to a fully automated system with some effort
Device or system is intended for multiple detection assays
5 or more solutions, buffer, eluents, and/or reagents
Less than 5 minutes is required for set-up
Greater than 12 steps are required for detection

LOGISTICS:

More than a day of training and significant technical skills are required
Approximately the size of a home dishwasher
Between 25 and 50 kg
Satellite, wireless and wired connections are available
System or device has 110V electrical requirement

OPERATIONS:

Can be used from 4°C to 41°C
Components must be frozen (-20°C)
Performance is not influenced by relative humidity
Between 6 months and 1 year shelf life
3-5 years expected life
Results cannot be viewed in real-time
The system could be adapted to a fully autonomous system with significant effort
The system software is open but modification requires licensing
The system hardware is open but modification requires licensing

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 10 µL
Superior specificity. System has a false alarm rate approaching zero (~0%)
1-100 CFU per mL
1-100 PFU per mL
Less than 1 ng per mL
Manual kit not integrated with the system handles spore lysis