>>BRANCHBURG, N.J. and AUSTIN, Texas, Dec. 19 /PRNewswire/ - Zeus Scientific, Inc. and Luminex Corporation (Nasdaq: LMNX - news) today announced that Zeus's new AtheNA Multi-Lyte® ANA Test System with Active Calibration Technology(TM) has recently received 510(k) clearance for commercialization by the Food and Drug Administration (FDA). The AtheNA Multi-Lyte® ANA Test System is based on Luminex's proprietary LabMAP(TM) technology. Zeus currently markets a successful line of IFA (Immuno-fluorescent Assays) and ELISA (Enzyme-Linked Immuno Sorbent-Assays) based tests in the autoimmune testing market.
Zeus intends to begin marketing its AtheNA Multi-Lyte® ANA Test System in the first quarter of 2002 through a distribution partnership with Wampole Laboratories, a MedPointe Company. Zeus's AtheNA Multi-Lyte® ANA Test System is intended to detect 9 separate analytes in human serum simultaneously. The test system is intended to be used as an aid in the diagnosis of various autoimmune disorders and is for in vitro diagnostic use. The AtheNA Multi-Lyte® ANA Test System offers analyses of patient specimens in a homogeneous, quantitative assay format, which is expected to significantly improve patient diagnosis and management. The AtheNA Multi- Lyte® system uses innovative proprietary Active Calibration Technology that adjusts the calibration curve within every well to match that sample's particular conditions and checks the accuracy and validity of the calibration curve. As a result, the kit provides a calibration curve not only for every test, but every patient sample.
``The AtheNA Multi-Lyte® ANA Test System utilizing Zeus's proprietary Active Calibration Technology is a highly accurate and innovative test system designed to provide the ultimate solution for clinical laboratories that routinely perform ANA testing. I believe the AtheNA Multi-Lyte is the most significant development in ANA clinical testing in over 25 years. It delivers the qualitative ANA test result as well as all of the reflex test results in less time than it takes to perform the conventional screening tests,'' stated Scott Tourville, Zeus's President.
Zeus plans to expand its product line based on the Luminex technology to other related diagnostic assays in fields of autoimmune and infectious disease testing. Under the terms of its agreement with Luminex, Zeus will pay Luminex a royalty based on the sales of its LabMAP-based products as well as distribute Luminex instrumentation and software.
``We are very pleased that Zeus has received clearance from the FDA to market its AtheNA Multi-Lyte® ANA Test System,'' stated Dr. Mark Chandler, Luminex's Chief Executive Officer. ``The first quarter 2002 launch of the AtheNA Multi-Lyte® ANA Test System will mark another in-vitro diagnostic test based on Luminex's LabMAP technology to be offered to laboratory customers in the United States and abroad.''
Luminex's open platform LabMAP system is a proprietary technology that performs up to 100 assays simultaneously on a single drop of fluid with the capability for both medium- and high-throughput assay applications. This system combines the use of low-cost microsphere-based assays with small lasers, advanced digital signal processors and proprietary software to offer greater speed, precision and flexibility over current bioassay technologies.<<
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cheers, Tuck |
