BioPAL(TM) Announces the Next Generation of Diagnostic Assays for the Kidney.

WORCESTER, Mass. -- Functional Immunoassay Technology (FIT) allows, for the first time, the development of diagnostic assays for glomerular filtration rate (GFR) and effective renal blood flow (ERBF) that are both accurate and easy to use.

BioPhysics Assay Laboratory (BioPAL), Inc. announced today that the company has filed a patent on the invention of Functional Immunoassay Technology (FIT). FIT can quantify a broad number of physiological functions of the body by measuring how externally administered molecular probes are processed by specific organs. FIT combines the administration of xenobiotics with the high throughput screening capability of immunoassay to yield a rate measurement that gives medically relevant physiological information regarding organ performance. Typically, these xenobiotics are chosen from readily available pharmaceuticals. The kidney is the first organ system chosen for new product development.

Renal disease is on the increase in America and throughout the world. The National Kidney Foundation notes on its website that "20 million Americans (1 in 9 US adults) have chronic kidney disease and another 20 million are at increased risk. Nearly half of people with an advanced form of kidney disease do not know they have weak or failing kidneys, according to recent research... Early detection can help prevent the progression of kidney disease to kidney failure." Because of its simplicity, measuring naturally occurring biomarkers, such as serum creatinine or cystatin-C, in blood and urine are the most frequently used tests to estimate renal function. Unfortunately, biomarker levels are influenced by many non-renal factors so these tests are not accurate. Despite recent efforts to improve these tests, they still have limited diagnostic value. Therefore, there remains a critical need for accurate renal diagnostics that better identify patients at-risk and better evaluate therapeutic interventions.

To make an accurate assessment of kidney function requires measuring the kinetic clearance of a probe administered under controlled conditions. Radioactive probes have been developed for this application but are not routinely used. Alternatively, researchers have introduced non-radioactive probes. These procedures require dedicated instrumentation, highly trained personal not commonly found in diagnostic laboratories and are not readily adaptable for multiplexing or high throughput. As a result, none of these alternatives have significant market share, nor have they become standard diagnostic tools for the field of nephrology.

BioPAL is applying FIT to measure GFR and ERBF. These two fundamental measurements in the field of nephrology allow researchers and clinicians to carefully gauge gradual changes in kidney function. BioPAL is developing a set of immunoassay tests to measure the presence of administered renal diagnostic probes in plasma and urine samples. FIT uses these tests in series to calculate the renal kinetic clearance of these probes and then provides an accurate measurement of GFR and ERBF. The FIT platform offers the following advantages: 1) immunoassay technology is well understood and accepted by the biomedical community, 2) all major diagnostic laboratories already run immunoassay tests, 3) the tests can be configured in different immunoassay formats, 4) the test lowers healthcare costs, 5) the diagnostic probes are readily available, non-radioactive, FDA cleared contrast agents, 6) immunoassay permits the simultaneous measurement of different functional parameters, 7) immunoassay is a highly sensitive analytical technology, which will minimize the amount of injected dose of contrast agent required when compared to competing non-radioactive technologies.

"FIT is a very innovative use of immunoassay technology in clinical practice," said Ernest V. Groman, Ph.D., VP R&D, "but FIT can also make a major contribution to drug discovery and development. The kidney is one of the most susceptible organs in the body to the potential toxicity of a new drug substance. Every new drug is tested for renal toxicity as early as possible in the drug discovery cycle in order to eliminate that compound before significant resources are invested. The availability of a simple test to measure true kidney function that can be started in preclinical animal studies and continued into human clinical studies is needed. FIT fills that need."

"Together, the FIT assays for GFR and ERBF give an excellent picture of overall kidney health," stated Christopher P. Reinhardt, Ph.D., President and CEO, "FIT will help doctors with managing high risk patients such as those with diabetes. These tests will also be a boon for the biotechnology and pharmaceutical industries because FIT will encourage the development of new renal therapeutic drugs and treatments."

"FIT will now allow any person in the world to be able to have an accurate kidney function test by simply visiting a local physician," said Dennis E. Vaccaro, Ph.D., Chairman. "FIT will screen at-risk people inexpensively and non-invasively to determine whether they have a problem or not. If widely adopted, FIT can save substantial costs by allowing early treatment of renal disease." Dr. Vaccaro added that "because these diagnostic tools also provide accurate measurements in animals, there is a large market in veterinary medicine. Given the many market-niche applications for FIT-based renal diagnostics, the total worldwide market potential could exceed one billion dollars annually."

BioPAL has been developing advanced renal diagnostic technology over the past five years. The company has been assisted in its efforts by three NIH SBIR grants totaling $1 million.

Founded in 1997, Worcester-based BioPAL, Inc. is a privately held biotechnology company with proprietary, breakthrough technology in diagnostic assays. BioPAL's core technology is stable isotope labeling of functional probes and Neutron Interrogation Technology (NIT) - a technology that promises to significantly streamline the drug discovery process and improve clinical methods for measuring organ function. BioPAL is also developing innovative products for time-resolved fluorescence (TRF) based on its proprietary lanthanide chelation and colloidal technologies, and MRI imaging reagents based on its Proton-Cascade technology. BioPAL is a leader in the post-genomic fields of "new physiology" and "systems biology." For more information please visit www.BioPAL.com or call 508-770-1190.