Hemagen receives FDA clearance to market test used in detection of cytomegalovirus.WALTHAM, Mass.--(BW HealthWire)--Feb. 27, 1997--Hemagen Diagnostics Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : HMGN HMGN Hemagen Diagnostics, Inc. (stock symbol) ) today announced it has received Food and Drug Administration 510(k) clearance to market its VIRGO ELISA ELISA (e-li´sah) Enzyme-Linked Immuno-Sorbent Assay; any enzyme immunoassay using an enzyme-labeled immunoreactant and an immunosorbent. ELISA n. CMV IgG kit. The test detects current or past cytomegalovirus (CMV) infection. The VIRGO ELISA CMV IgG test kit joins Hemagen's growing line of infectious disease test kits. Dr. Carl Franzblau, president of Hemagen, said the VIRGO CMV IgG test is produced in the increasingly popular ELISA (enzyme-linked immunosorbent assay enzyme-linked immunosorbent assay n. ELISA. Enzyme-linked immunosorbent assay (ELISA) A diagnostic blood test used to screen patients for AIDS or other viruses. ) format and is the first in a series of VIRGO ELISA kits to be produced in 1997. The test kit detects antibodies to cytomegalovirus (CMV) in human serum. CMV infection may induce life-threatening conditions such as pneumonia, fever and hepatitis among immunosuppressed Immunosuppressed A state in which the immune system is suppressed by medications during the treatment of other disorders, like cancer, or following an organ transplantation. Mentioned in: Fifth Disease patients. CMV is a double-stranded DNA virus with characteristics common to members of the herpesvirus herpesvirus, any of the family (Herpesviridae) of common DNA-containing viruses, many of which are associated with human disease. See cytomegalovirus; Epstein-Barr virus; herpes simplex; herpes zoster. family. The virus may remain in a latent state indefinitely following infection or it may emerge from time to time as an active infection. Hemagen Diagnostics Inc. develops, manufactures and markets more than 100 FDA-cleared proprietary medical diagnostic test kits used to aid in the diagnosis of autoimmune and infectious diseases and to measure important constituents in human blood. The company focuses on markets which offer significant growth opportunities. Except for any historical information contained herein, the matters discussed in this press release contain forward-looking statements that involve risks and uncertainties which are described in the company's Securities and Exchange Commission reports and filings. CONTACT: Hemagen Diagnostics Inc. William Franzblau, 617/890-3766 or Boutcher & Boutcher Dan Boutcher, 201/239-2878 or Steinerman Biomedical Communications Inc. Peter Steinerman, 516/374-3031 |
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