MIAMI, Fla., December 3, 2002—Hyperion, a leading South Florida manufacturer of innovative medical diagnostic instruments and reagents, today announced the receipt of the FDA's 510(k) clearance for immediate marketing of its VisiQuant™ Antinuclear Antibody Test System. The VisiQuant™ instrument is the industry's first fully automated, computer controlled, digital microscope. It will initially be marketed with Hyperion's antinuclear antibody (ANA) test kit which received FDA clearance in June. ANA tests are used as an aid in the diagnosis of autoimmune disease. The most common autoimmune diseases include systemic lupus erythematosus, Sjogren syndrome, rheumatoid arthritis, polymyositis, scleroderma, mixed connective tissue disease and pulmonary fibrosis.

The Hyperion HyPrep Plus™ (far left) and Hyperion VisiQuant™ (far right) are connected by a personal computer to create a VisiQuant™ System

The VisiQuant™ System which consists of the automated microscope, Hyperion's HyPrep Plus™ assay preparation laboratory robot, and a personal computer represents several medical diagnostic breakthroughs. It is the first and only diagnostic system which is capable of fully automating ANA testing when done by the preferred Immuno-Fluorescent Assay (IFA) method. It substantially reduces the number of manual steps and reduces technician time from hours to minutes. Automation further insures consistency in testing, reduces the probability of technician induced errors, and eliminates some of the objectivity involved in interpreting these tests. Perhaps VisiQuant's largest performance advantage over existing technology is its elimination of the titration step required in all other assays. The VisiQuant™ replaces this second step, which consumes roughly as much time and material as the initial sample assessment, with a discrete numeric value which indicates the level of bound fluorescence in the sample. This system is also unique in its ability to produce a permanent patient record in the form of a digital image of the test result recorded together with all of the other relevant test results.

The introduction of the VisiQuant™ system marks the first major improvement in ANA testing since the procedure was developed by Dr. George Friou in 1957. This system's automation, digitization, and objectivity all speak directly to the challenges being faced in today's diagnostic laboratories. Furthermore, VisiQuant™ accomplishes this without sacrificing any of the benefits of fluorescence based testing which remains the industry's gold standard in antinuclear antibody testing.

”I believe that the system will sell well on the merits of either its features or the substantial economies it represents to laboratory managers” stated Mark Turner, Hyperion's VP of sales and marketing “This system virtually eliminates at least 20 man hours per week of highly skilled technician time in labs that do a low volume of ANA testing. The test kits themselves are priced competitively with those of our non-automated competitors. The VisiQuant™ caused considerable excitement at the recent American College of Rheumatology and MEDICA exhibitions.”

Hyperion is a South Florida based medical diagnostics company which has spent the last decade and approximately $13 million in capital developing a fundamental technology that promises to revolutionize mainstream in vitro medical diagnostic procedures. Hyperion's basic, patented technologies are its La Jolla Blue fluorophore and its Transient State Measurement technique. Individually, each of these technologies represents a roughly tenfold enhancement over prevailing diagnostic technology. Taken together, they represent a 100X sensitivity improvement as their respective contributions to signal strength reinforce one another. In combination, these technologies have the potential to displace the majority of current test equipment and reagents in laboratory settings and to enable tests in a point of care environment that are not possible with current technology.

For further information, please contact Frank L. Young, CEO, at 305-238-3020 or visit the Company's website at www.hyperionclinical.com