The Target System Micro-Flow Technology enables a broad test platform. The system combines a unique technology with an unmet market need resulting in a large market opportunity.
Target System Cartridge
A core component of the Target System Diagnostic Platform is the Test Cartridge. Parallax's Test Cartridge has a flow-through design allowing any prepared sample to be applied to a membrane system, thereby facilitating rapid absorption, test solution application, and test development in one single device. The Test Cartridges can be used with samples derived from different biological origins including whole blood, urine, serum, or fecal specimens. The Test Cartridges are less than two inches tall and can be transported easily over long distances and in large numbers. The Test Cartridge is proven in diagnostic laboratories and, as such, all tests are adapted to this format. Parallax's platform utilizes a vacuum technology to deposit specimen samples uniformly on test membranes. Excess specimen absorption is built in.
Medical personnel place a blood drop onto the Target System Cartridge, adds test chemistries and loads into the reader. A single style cartridge is used for all panels.
- Reader for analyzing test results
- Whole blood sampling
- Low manufacturing cost consumable
- Designed for CLIA waiver
- Bar coded tracking
- Vacuum pump technology
Value Proposition of Target System Technology
- Parallax's Target System is non-disease or condition specific. The Target System platform can test multiple diseases or conditions.
- The Target System saves time and money. All Target System tests develop quickly with consistent reading of results, thereby limiting training needs.
- The Target System allows for a "While you Watch result" test period. The test is complete in 2-5 minutes in the Qualitative tests and 5-10 minutes in the Quantitative tests.
- The Target System allows for a physician to take back control of the testing process. It has built in operator controls for sample development.
- The Target System is based on a proven methodology, rapid Immuno-Assay tests that have a 20 year successful track record.
- The Target System is based on test principals that work under a wide range of conditions. Qualitative: The stain on the membrane creates a yes or no result. Quantitative: The reflection of light received from the sample is easily qualified.
- The Target System is the only "Flow Through" test with specific control features. It incorporates a vacuum pump with operator controls built-in and patent protected.
- The Target System has the ability to test any substance from plasma to dirt. The platform's built-in sample filtration allows for variable substance analysis.
- The Target System offers consistency in the way in which the test results are read. All qualitative tests produce the same positive or negative results and have a built-in control ring to insure that the test is functioning correctly.
- The Target System ease of use features allow for a "train once platform". All qualitative tests develop in the same manner with the same result readings. the operator uses the same type of test whether it be Pregnancy HIV or any other qualitative test.
- The Target System offers Point-of-Care versatility. The platform offers immediate results in the Point-of-Care environment of diseases or conditions.
- The Target System has the ability to overcome environmental variables. The platform's built-in operator controls provide a controlled flow of sample to the testing surface, providing consistent results under less than ideal lab conditions.
- The Target System has a Patented Vacuum Technology. The platform's vacuum technology separates undiluted material from the sample, providing for a cleaner sample.
- The Target System is not affected by barometric pressure. For sample processing the platform eliminates the effects of gravity or barometric pressure on the testing process.
- The Target System has a built in Specimen Filtration feature. The platform's variable micron filter provides for the elimination of specimen inconsistencies.
- The Target System has a greater Sample Contact on the test surface. The platform's vacuum action results in a wider specimen dispersal over the test surface, resulting in a more accurate test.
- The Target System can be used for qualitative, semi quantitative or quantitative tests. The Mobil reader will be bar code activated, eliminate complicated training, minimize user error and calculate all test results.
- The Target System has an accelerated specimen development time ("While you Watch"). The vacuum control feature pulls the sample through the test surface allowing for accelerated development.
- The Target System's quantitative tests allow for the ability to read a multi light spectrum. The broader light spectrum allows for large particle or small particle identification.
- The Target System is ideal for mobile medical or temporary triage environments, as well as immediate results in extreme field conditions. The platform provides for "While you Watch" results in time sensitive environments.
- The Target System has the ability to utilize lyophilized (freeze-dried) reactive agents. This feature allows increased shelf life of the reactive agents and the usability of the tests.
- The Target System is a stabilized technology. Its testing application has been tested for over 20 years.
- The Target System eliminates the possibility of specimen mishandling associated with processing through large lab. The Point-of-Care provider handles the test sample from start to finish.
- The Target System eliminates chain of custody issues. The Point-of-Care provider has the test in his possession from start to finish.
Ubiquity and Interoperability of Application Flexibility
Incorporated in the design paradigm of the controlled flow system is the ability to rapidly adapt the device to new infectious disease threats. This flexibility in a device provides for a cost effective and rapid response for the primary care physician, trauma care nurse, emergency response providers.
Medical diagnostics, health monitoring or emergency responses are currently limited by the time it takes to recognize a potential threat and the time it takes to obtain a proper result from a testing laboratory. For example, the duration from a 911 call to the appropriate diagnosis of a possible heart attack of a patient is more than one hour, the most crucial time in treatment to prevent long-term damage to a heart disease victim. On the contrary, a large number of heart attack victims, predominantly women that do not exhibit the "standard" symptoms of heart attacks are released from the ER without even being diagnosed appropriately. In other situations, e.g., ambulant services to potentially HIV positive individuals, testing is never performed in the time-frame available, and thus patients are never informed about their condition.
These examples can be expanded to environmental testing and the occurrence of a toxic spill or the contamination with biological weapons like anthrax. Food contamination has become a serious health and security risk. In these cases, laboratory testing often takes days, if not weeks. In all of these situations, a point-of-care diagnostic or testing system would provide the ability to largely eliminate the current threat or to minimize the adverse consequences of an emergency.
Ease of Use
Parallax's patented platform provides tremendous flexibility in sample requirements, clinician training and result interpretation. Parallax's "train once" system means the clinician can now perform a number of single use tests on a wide variety of conditions with the interpretation of results consistent through the platform paradigm.
Universal Application and Economy of Scale
Parallax's unique vacuum pump action reduces test time and ensures maximum contact with the membrane antibodies. This patented collection device is virtually unlimited in the number of different tests that can be incorporated. Through a modification to existing FDA 510(k) clearance, the device is ideally suited for rapid FDA clearance of all new tests that may be introduced. The economy of scale is provided to health care provider or any other customer group by being able to utilize a single test system for multiple tests with varies little variance in training needed. A clinician can move from one test to the next in a matter of minutes.
Furthermore, the capability of acquiring and transmitting patient related data in addition to the tests performed at the point-of-care enable Parallax's Hand-Held Analyzer to become the central diagnostic device in a decentralized, patient oriented, and cost-conscious environment to provide or maintain a high level of health care in the face of threatening epidemics.
Safety and Accuracy by Design
For all tests, Parallax's bar code activation system identifies the test to be analyzed, allowing only those medical personal that possess that test will be aware that it is available. Without Parallax's specific Target System Test Cartridge, read by the bar code reader, the Analyzer will not calibrate to that Test. This precludes mistakes by the user or erroneous results by the devices.
Each Test Cartridge bar code must be read to initialize the Device and load the appropriate algorithm from the software table. This provides a level of security for patient related tests and eliminates errors based on operator's mistakes.
Parallax provides a combination of innovative, fast, and inexpensive diagnostic and testing products with a highly mobile data collection and transfer test reader. In this regard, Parallax's Target System is suitable for rapid, point-of-care testing in almost every environment, which includes emergency situations, remote locations within the US as well as other parts of the world, immediate response teams, personal testing in a home setting, and many more.
Advantageously, many different tests can be performed using the same reader, e.g., either Parallax's Target System Desktop Analyzer or its Hand-Held Device, at any location.