Parallax Diagnostics (www.parallaxdiagnostics.com) is a wholly owned subsidiary of Parallax Health Sciences which owns a line of proprietary, FDA approved, Point of Care single platform diagnostic tests focusing on the detection and monitoring of infectious diseases.
In recent years, there has been a continuing shift from the use of laboratory-based analyzers to more technologically advanced point-of-care tests that can be performed in a matter of minutes. Unlike the centralized clinical laboratory segment, which is mature and highly competitive, the point-of-care market is still a relatively early stage market. Although certain simple single analyte diagnostic tests have been developed, such tests have remained incapable of precise and highly sensitive quantitative measurements. As a result, medical tests that require precise quantization of the target analyte have remained the domain of immunoassay analyzers.
We believe that there is a significant market potential for advanced point-of-care diagnostic products that provide quick and accurate diagnosis during a patient visit, shortening the decision time to medical intervention and minimizing the need for additional patient follow-up, thereby reducing overall health care delivery costs.
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TADS Diagnostic Platform
Parallax's Target Antigen Detection System ("TADS") Diagnostic Platform is a Controlled Flow-Through Rapid Immunoassay Technology, offering an array of improved modifications and features to the traditional Flow-Through Immunoassay Test. With its Platform uniformity, vacuum pump, absorption layer for sample overflow, and complete compatibility with Parallax's optic reader, the Target System Diagnostics Platform is a unique collection of tests for qualitative and quantitative detection of patient conditions.
Parallax's Target System Diagnostic's "Vacuum Control Flow Device" unique vacuum pump action reduces test time and ensures maximum contact with the membrane antibodies. This collection device allows for a vast number of tests to be incorporated. Through a modification to existing FDA 510(k) clearance, the device is ideally suited for FDA Clearence of all new tests that may be introduced.
Parallax's products include a FDA-cleared desktop test reader and more than a dozen FDA 510(k) cleared tests. Parallax owns a number of patent applications on the underlying technology as well as methods for future test development.
Proven Lab Quality Results
The Target System will offer the physician access to a POC system that meets high performance standards. By meeting this US market standard, physicians will have real time diagnostic results that they can feel confident in when making clinical decisions. The Target System Platform features a breadth of testing capabilities to include both qualitative and quantitative tests. A novel approach to CD4 and CD8 immune status tests are in development and will be the lead novel test for Parallax.
Real Time Results in Less Than 10 Minutes
Reference lab results often take 2-5 days to report to the physician. These systemic delays, prevalent in the current physician practice workflow, result in more non-productive work for the physician and his/her support staff, as well as unnecessary delays in treatment.
Compared to reference labs, the Target System results are available in minutes allowing the physician to review results with patients and make clinical decisions in one visit. This more efficient handling and diagnosis will greatly decrease total staff invovement and increase patient satifaction.
Real Time POC Results
In the field of clinical medicine, more than 60% of all physician decisions are guided by diagnostic information. There is a demonstrated need for high quality, real time POC test data. However, most lab results take days to report. Physicians and patients wait as a consequence.
To meet this need for real time, POC test results, Parallax has acquired the Target system, a technology platform that will enable in vitro diagnostic tests to be performed in the physician's office providing reference lab quality results within minutes.
Universal Platform Means More Tests at a Lower Cost
The Target System will challenge the reference lab model, due to its Micro-flow-through Technology that can function as a universal platform for the most frequently ordered tests. Whereas other POC alternatives require multiple instruments, each dedicated to a few specific tests; Target System is a single platform that can analyze a multitude of tests from universal Target Cartridge type
A single technology and cartridge platform reduces total system cost, simplifies manufacturing processes, and reduces technology complexity - all critical factors in lowering the cartridge cost. With the potential to reach cartridge-manufacturing there are significant market opportunities in both developed and developing counties that will eventually establish Parallax as a major force in global diagnostics.
Target System Desktop Immunoassay Analyzer
Parallax's Target Desktop Analyzer is an FDA 510(k) Cleared immunoassay reader that is capable of rapidly analyzing qualitative and quantitative data for the Company's FDA-Cleared Target System Platform tests. The Target instrument is used for all Target System Platform tests, allowing for clinical personnel to be trained once and also gives consistent results for either qualitative or quantitative testing. The Target System processes the Target Cartridge and displays a full test result within minutes.
he target analyzer is capable of rapidly analyzing quantitative data. It can be used in a variety of point-of-care settings, from clinics and doctor's offces to first response medical teams and emergency rooms. It is AC or battery powered with a built-in printer, making it fully portable and easy to operate.
SPARKS Mobile: Target System's Hand-Held Version
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.
Parallax's proprietary Target System family of tests encompasses a number of diagnostic tests ranging from Infectious Disease Diagnostics to Cardiac tests. The Parallax tests are based on a unique Micro-Flow Through rapid test platform. The Parallax System is able to provide quantitative and qualitative tests and is fully ubiquitous and interoperable with multiple tests.
Target System Qualitative Diagnostics detect the presence of specific markers and the results are indicated as a positive or negative. The Qualitative Diagnostic specimen collection kits are all-inclusive and can be administered and qualified without the need for additional hardware.
Rapid enzyme immunoassay for qualitative detection of rubella virus specific IgG antibody. Rubella is a highly contagious yet generally mild disease in most people. However, it has great significance in women infected with rubella, the virus may infect the placenta, multiply and induce serious damage ti the fetus, including low birth weight, cardio vascular detects, mental retardation and bone defects, therefore all women of child bearing age, as well, as school age children and healthcare personnel should be screened for immunity to rubella.
Rapid enzyme immunoassay test for qualitative detection of human rotavirus particles and antigens in human fecal specimens. Rotavirus is a major cause of gastroenteritis in infants, young children and the elderly. During the winter months a portion of gastroenteritis in children is due to rotavirus infection. The disease manifests with the symptoms of vomiting diarrhea, and fever. Rapid and accurate diagnosis is important to avoid inappropriate antibiotic therapy, provide proper treatment early and to prevent spread of nosocomial infection.
CMV - Herpes
Rapid enzyme immunoassay for qualitative detection of antibody to Cytomegalovirus in serum and plasma. Cytomegalovirus (CMV) is human viral pathogen belonging to the herpes family. Infection in humans is wide spread and usually results in asymptomatic disease. However, severe symptomatic infections, a very significant risk in infants and immunocomprised patients.
Group A Streptococci
Detects group A streptococci, the cause of upper respiratory infections and pharyngitis. Identification is essential for the selection of appropriate antibiotic therapy to avoid complications such as acute glomerulonephritis or rheumatic fever. The test detects group A strep antigen directly from extracted throat swabs or swabs from culture plates for test confirmation.
IM - Infectious Mononucleosis
Qualitative detection of heterophiles antibodies associated with infectious mononucleosis. IM is an acute disease caused by the Epstein Barr virus. Heterophile antibodies are the primary antibodies, which appear in the patient's serum, usually 1 to 3 weeks after the onset of common symptoms include fatigue, pharyngitis, fever, Iymphadenopatherapy and splenomegaly.
Today, over 42 million people are estimated to be living with HIV/AIDS. Of these, 38.6 million are adults. 19.2 million are women. With the recent advent of Rapid HIV testing, HIV detection and prevention programs around the world have become increasingly effective by reducing their time and costs of detecting the virus, thus allowing for a far greater number of individuals to be screened.
Target System Qualitative Diagnostics detect the presence of specific markers with the results indicating definitive levels present. The quantitative tests can be developed in minutes utilizing the Target Desktop Analyzer.
Quantitative Immunoassays would allow:
Detection of the absolute concentration of components
Reduce inter-assay variation in data
Permit successful statistical analysis of smaller sample sets
Permits direct comparison of data generated at independent sites or occasions.
Creatine Kinase (CK) Muscle (M) Brian (B) Rapid immunoassay for the quantitative detection of CK-MB. CK-MB measurements in serum can provide useful information to help confirm or exclude that myocardial infraction has occured. The amount of CK-MB released can also assess the infract size. CK-MB is found predominantly in the myocardial tissue. Detectable increases in CK-MB levels from non-cardiac sources are rare.
Rapid enzyme immunoassay tests for the quantitative detection of Myoglobin in serum and plasmas an aid in the rapid diagnpsis of acute myocardial infarction.
C-reactive protein is an acute phase protection. The test is a solid phase gold immunoassay for the detection of CRP. Quantitative CRP measurements have been found to provide reliable early indication of postoperative inflammatory complications if mentioned on a daily basis. CRP is also predictive of clinical cardiovascular disease.
Rapid enzyme immunoassay tests for the quantitative detection of cardiac troponin I in serum and plasma as an aid in the rapid diagnosis of myocardial in fraction. Troponon is a thin filament associated complex of the myocyte. Troponin I is a protein with a high specificity for cardiac injury.
Promise CD4-8 (In Development)
Parallax has initiated the development of an assay to measure CD4 and CD8, is intended to be a Rapid, Quantitative, Mobile, Point-Of-Care test for determining the immune status in HIV infected patients in order to evaluate whether an HIV patient can start Anti Retroviral Therapy (ART) and to monitor the effects of ART on the patient over time.
Drugs of Abuse
DrugStop, a home drug test product cleared by the FDA will be marketed to consumers.