UltraPlex™ FingerPrint Profiling Assays
Molecular fingerprinting is a new approach to medical diagnostics. Fingerprints based on genes or proteins, and generated by expensive equipment such as NMR machines or mass spectrometers, have shown tremendous promise in research laboratories. To date no practical and economic method has previously been devised for generating such profiles. However, UltraPlex™ now makes delivery of revolutionary profiling diagnostics, at an acceptable cost to users, a reality.
Pronostics is using its proprietary UltraPlex™ platform technology, antigen libraries, and pattern recognition software to create biological fingerprints focusing on profiling the complete immune system of an individual from a single simple blood sample. By measuring the levels of thousands of chemicals in a blood sample simultaneously it is possible to construct a profile of an individual which can be used to safely and accurately diagnose a wide range of different diseases. Pronostics first FingerPrint product, CADPrint™ will be commercially available during 2008.
CADprint™ - Satisfying a Clinical and Economic Need
Pronostics has selected coronary artery disease (CAD), the number one killer in the Western hemisphere, as the first disease area to address using its FingerPrint profiling technology. In the UK Coronary Heart Disease affects 1 in 3 individuals at some time in their lives, resulting in more than 100,000 heart attacks annually, some 40,000 of which are defined as premature. Despite its prevalence, and the availability of well-validated therapeutic options such as statins, and imaging modalities such as EBCT, MIBI perfusion scans and IVUS, the ability to obtain a reliable diagnosis of CAD rapidly, at acceptable cost and in a non-invasive manner remains surprisingly elusive.
Today, the diagnostic paradigm involves a hierarchical application of low cost, low power biochemical tests, followed by physiological tests (such as ECG) and ultimately high cost, invasive angiography. However, even though regarded as the gold standard for diagnosing the presence of CAD, diagnostic angiography carries significant risk for the patient (3 in 100 are associated with significant morbidity and 1.5 in 1,000 with mortality) and it represents a heavy financial burden for healthcare providers (>$1,000 marginal cost per angiogram). This hierarchical approach is time consuming and expensive and yet still fails to identify many individuals who go on to have a heart attack!
There is therefore a clinical and economic imperative for a preliminary, non-invasive way to assess a patient's arteries to determine if invasive examination is warranted. Today, $3.5 billion a year is spent worldwide on non-invasive tests that lack the power to diagnose CAD with acceptable sensitivity and specificity. Pronostics and its team of collaborators have been working together, for the last five years, to develop a new, lower cost, non-invasive profiling diagnostic for CAD, and the result is our first FingerPrint profiling product - CADprint™.
FingerPrint profiles generated by CADprint™, from a simple drop of blood, are compared, using advanced pattern recognition algorithms, to a database of profiles from individuals of known CAD status, thereby identifying signatures that can be used to provide a definitive diagnosis of the disease. Pronostics' proof of principle experiments for CADprint™ obtained a diagnosis of the presence of coronary heart disease, with greater than 90% sensitivity and specificity.
CADprint™ is currently being tested in a routine clinical environment, using standard clinical phlebotomy and biochemistry services and a multi-centre clinical trial, PUMA, is currently underway recruiting approximately 1,000 patients from rapid-access chest pain clinics across the UK. CADprint™ will be applied to the trial's samples to validate the patients' predicted disease status against the current gold-standard diagnostic practice of angiography.
The lead clinicians at each site in the multi-centre trial, in addition to managing the implementation of the trial, and its governance, are providing input into the development of the final commercial version of CADprint™. In particular, the clinicians will advise on the format of the output from the test and the nature of the documentation and training associated with CADprint™.
Pronostics estimate that widespread introduction of the CADprint™ test, assuming performance similar to our pilot studies, would double the identification rate of probable future heart attack sufferers, and provide the time to begin therapeutic intervention. This would be achieved without any increase in the health-providers' resources employed and would translate into approximately a 10% reduction in overall CAD morbidity and mortality.
''If Pronostics can deliver on the promise of their technology, it will improve our delivery of cardiovascular health care, and relieve some of the burden of ever rising costs for the UK National Health Service'' said Peter Schofield, Consultant Cardiologist at Papworth Hospital, who has collaborated on the development of CADprint.
Pronostics plan to launch CADprint™
during 2008.
Future UltraPlex™ FingerPrint Profiling Assays
Pronostics is confident of demonstrating that UltraPlex™ FingerPrint Immunomics is generally applicable and pilot studies have demonstrated that multivariate diagnostics have the potential to revolutionise in vitro diagnostic provision across a broad range of the most prevalent disease areas. We do not presently know whether our next FingerPrint immunomic tests can replicate CADprints™ diagnostic power in other diseases, but an important strand of our research activity over the next few years will be to obtain data using various antigen libraries in a number of carefully chosen disease areas where we believe such products would yield most patient benefit.
