INCSTAR RECEIVES FDA CLEARANCE TO MARKET NEW TEST FOR INFECTIOUS MONONUCLEOSIS
INCSTAR RECEIVES FDA CLEARANCE TO MARKET NEW TEST FOR INFECTIOUS
STILLWATER, Minn., Oct. 1 /PRNewswire/ -- INCSTAR Corporation (AMEX: ISR) today announced that it has been given 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market its new test for the detection of antibodies to Epstein-Barr Virus Early Antigen. Epstein Barr Virus (EBV) is the causative agent of infectious mononucleosis.
INCSTAR's assay utilizes enzyme-linked immunosorbent assay (ELISA) technology which has advantages over the traditional indirect fluorescent antibody (IFA) technology. IFA assays are laborious and require the experience and subjective judgment of an expert technician. The company's ELISA test is simple to perform with clear-cut results.
With the addition of the EBV Early Antigen test kit, INCSTAR now offers a full line of five tests for the detection of related antibodies to EBV. Tracking the relative levels of the various antibodies to EBV can be utilized in the diagnosis, confirmation and monitoring of infectious mononucleosis.
INCSTAR is a Minnesota-based manufacturer and distributor of high quality immunodiagnostic products for health care professionals and manufacturers. The company is an affiliate of the Italian-based Fiat Group (NYSE: FIA).
CONTACT: Jack Falker of Swenson Falker Eilertsen Inc., 612-371-0000 or John Booth of INCSTAR, 612-779-1700
(ISR FIA) CO: INCSTAR CORPORATION IN: MTC ST: MN -- MN001 -- X936 10/01/92