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The FastDetect Platform

FastDetect Instrument

RT-PCR

The FastDetect instrument is an innovative diagnostic device utilizing RT-PCR (reverse transcription polymerase chain reaction) for rapid pathogen detection in a wide range of sample types. The device incorporates cutting-edge heating, cooling, and optical elements, invented at Caltech, to run full-cycle PCR in approximately 15 minutes, compared to the hours required for gold-standard laboratory machines. FastDetect’s multi-channel engineering allows multiplex assays to detect up to three unique pathogens, and pool up to five samples, per run.

FastDetect - Simple to use RT-PCR device constructed with patented high-performance optical and heating components
Simple, Rapid, On-Site

While the FastDetect instrument benefits from the high accuracy that the RT-PCR technique produces, due to its innovative design and engineering, it suffers none of the drawbacks. Most RT-PCR instruments need to be housed in CLIA-certified, high-complexity labs in controlled environmental conditions and with strictly calibrated parameters under the direct supervision of highly trained technicians. In contrast, FastDetect has been designed from scratch to operate on-site, outside environmentally controlled labs, and without the need of specially trained technicians.

Highly Accurate

FastDetect was developed during the SARS-CoV-2 pandemic and has been verified in laboratory studies to detect the virus with >98% sensitivity and specificity. Moreover, it is ultra-sensitive and able to detect virus on par with the most sensitive laboratory machines in the world. As the R&D team continues to develop new detection assays for companion animal and livestock pathogens, we anticipate similar performance in terms of accuracy and sensitivity.

FastDetect Cartridge

Once the sample is inserted in the FastDetect disposable cartridge, the operator of the device does not need to manually handle the sample again, making the testing process both biosafe and simple to execute. All the operator needs to do is insert the cartridge into the FastDetect instrument and press the Start button. The FastDetect instrument will undertake and control the timing of all the necessary steps to conduct an RT-PCR test fully automatically.

FastDetect - Fully self-contained and inexpensive assay cartridge engineered for multiplex pathogen detection in ~15 minutes

At the end of the testing cycle, the answer is stored in the FastDetect encrypted database and securely communicated to the appropriate parties. The operator is notified that the testing cycle is complete so to remove the cartridge from the instrument and appropriately dispose it. The instrument is then immediately ready to receive a new cartridge to conduct a new test. No special cleaning or sterilization steps need to be undertaken by the operator, as those are conducted by the instrument automatically.

The cartridge design allows for the steps to be executed in the appropriate order fully automatically under the control of the instrument. The cartridge components are produced from recyclable polymers and metal.

FastDetect Consumables - Feline

FastDetect Sample Pooling

The cartridge has been designed to receive sample material from either only one individual (test subject) or from multiple test subjects. The former allows for determination of infection in one specific individual. The latter, termed “sample pooling”, allows for the simultaneous testing of multiple people in a “pool” so to allow for the testing of large numbers of test subjects in short periods of time. If the pool tests negative, no individual in the pool is infected by the virus. If the pool tests positive, at least one individual in the pool may have the virus and individual testing of the members of the pool is then required to ascertain which members are infected.

Sample pooling, combined with low instrument and cartridge costs, makes for very affordable, high accuracy, rapid testing. It is expected that the material cost of conducting RT-PCR testing with FastDetect will amount to just a few dollars per person, more than an order of magnitude cheaper than current RT-PCR tests.

FastDetect Sample Pooling

FastDetect Software

The instrument and the cartridge become a functioning testing system with the help of proprietary software that both directly controls the operations of the instrument as well as stores and communicates the test answer back to the appropriate parties.

The control software automates the operation of the instrument during all facets of the testing process. It verifies the existence of a new and properly inserted cartridge and it systematically cycles through the necessary steps which move the sample among the containers in the cartridge at the appropriate times. It also controls the rapid thermocycling process necessary for the RT-PCR technique and notifies the operator on completion of a testing cycle. Finally, it handles any errors and manages the storage of the answer on the FastDetect secure database.

The customer software allows the customer who wishes to be tested to register for the test and to receive the result of the test upon completion.

FastDetect software - results

The operator software enables the operator to associate the sample with the customer and also associate the sample with the cartridge and appropriate instrument. It also allows the operator to monitor the status of the testing cycle and be notified about any errors.

The administrator software allows for the configuration of the testing site and the instrument(s) used at a testing site and to supervise the overall operation of the testing site. It also provides reports associated with the tests and test subjects.

All FastDetect software components are HIPAA compliant and use encrypted communication and storage to protect the privacy of the health information of the customers/test subjects and ensure appropriate safe keeping and sharing of test results.

FastDetect Software - map