A re-engineered version of Parallax's previously FDA-approved Desktop Analyzer.
What is SPARKS Mobile?
Parallax's next generation Target System Analyzer will be a mobile Hand-Held Reader called SPARKS Mobile, it is currently under development, and will include a small, rapid testing format, in conjunction with a hand-held data acquisition and test reading device. The SPARKS Mobile will be a re-engineered version of the Company's previously FDA 510K Cleared Target Analyzer.
Whether searching for markers in the blood stream, or diagnosing a pathogen in urine, the SPARKS Mobile will be a portable tool for rapid diagnostics. The SPARKS Mobile will also provide an improvement in POCT diagnostics and applications in countries with limited health care infrastructures and geographic limitations, both of which are of paramount importance in the combat against infectious diseases and in the fight against proliferation of endemic and pandemic diseases.
The SPARKS Mobile will allow for a fast (minutes instead of hours or days) performance of tests at the point-of-care, and will only require a test cartridge and a small number of ready-to-use solutions in preformatted quantities. Moreover, the SPARKS Mobile will include the ability to store patient, test, and other data, and transmit data through wireless connections.
The SPARKS Mobile is being developed to:
Achieve a portable system, which is compatible with proven and reliable ELISA-based Target System technology.
Expand readout capabilities to provide a mobile testing and monitoring platform.
Increase the economy of scale and scope of the diagnostics platform by the development of additional utility of the device without redundant infrastructure investments (additional data acquisition of patients, additional tests for other, predominant diseases).
The basic design of the SPARKS Mobile is based on the same FDA 510(k) Cleared technology employed in its Target Analyzer and is compatible with existing Target System Test Cartridges. However, a number of innovative features will be integrated into the design to meet customer and patient needs:
High Infrared Light Spectrum
Multiple light source system providing variable light wave analysis into the infrared spectrum. This diversity in light source and detection will allow for the simultaneous identification and diagnosis of a broader spectrum of different targets within the same sample and assay. It will also allow for very specific test development, without having to develop a new analyzer to read the results.
Easy Field Upgrades
Field software upgrades made through memory chip (SIMM) or Flash memory stick.
No Change of Equipment
The same Analyzer will be used for all TARGET SYSTEM Tests and will be able to be used on all future tests, allowing for training personnel only once, and displaying consistent test results on an easy to read LCD screen.
Printer Hook-up Capability
When hooked to a printer, either via traditional plug-in or Bluetooth or wireless, the SPARKS Mobile will be able to provide printed results for ant Target System Test, both Qualitative (when written results must be stored with original test for HIPPA and other compliance issues), or Quantitative (measured amount analysis must be printed and maintained in the patient chart folder).
Low Entry Cost for New Test Development and Analysis
Due to the technologies' broad capability, a new analyzer will not have to be developed for different samples types (blood, serum, plasma or urine).
Safety, Security and Accuracy by Design
For all tests, the SPARKS Mobile bar code activation system will identify the test to be analyzed.
Desk to Docking Station
The SPARKS Mobile will be able to be configured with or without a desk-to-docking station. The docking station will provide a stationary platform when in use in an office or non-mobile application. It will also provide the user to set up multiple tests samples while the analyzer is processing tests.
Smart Phone Capability
The SPARKS Mobile will have many Smart Phone Capabilities including, but not limited to, Bluetooth, Wi-Fi, MMS messaging, SMS, and Memory Cards, internal memory expandable to 36 GB, data transfer, and more.
Optimal Market Use
Parallax mobile testing, data acquisition, and data transmission system meets the needs for diagnostics in particular in areas where either no structured health care systems exist or where - due to geographic nature and population density and distribution - a more decentralized approach is necessary.
The hand-held analyzer can be used in basically all environments, and is suited to use power sources independent of an electric network (rechargeable batteries, solar panel, running on motor vehicle voltage and power supply).
The tests can be performed within short time periods, and do not require the performing medical personnel, the physician, or the patient to return for test results or potential initiation of treatment.
Reference lab quality, real time, easy to use, and low cost diagnostic testing lets physicians treat their patients in one visit.
For the Company and its efforts to design SPARKS Mobile for optimal market use, this means:
Development of a mobile hand held testing system, which is compatible with proven, and reliable ELISA based Target System technology.
Expansion of the capabilities of the handheld device to provide a mobile testing platform.
Increase the economy of the diagnostics platform by the development of additional utility of the device without redundant infrastructure investments.
Acceptance of the Company's testing system as well as the platform within the medical community of African, Asian, and other countries with mounting problems in the field of HIV and other infectious diseases.