Hemagen Announces FDA Clearance of New High Sensitivity CRP Reagent.

Business Editors/Health & Medical Writers

COLUMBIA, Md.--(BW HealthWire)--Aug. 6, 2002

Hemagen Diagnostics, Inc. (NASDAQ:HMGN) announced today that it received FDA clearance to market a High Sensitivity CRP Reagent for use on Clinical Chemistry Analyzers through its RAICHEM division.

The Raichem CRP High Sensitivity Test System, which includes both the reagent and calibrator were determined to be substantially equivalent to other legally marketed predicate devices.

CRP (C-reactive protein) is an acute phase protein whose concentration is seen to increase as a result of the inflammatory process, most notably in response to pneumococcal (bacterial) infections, histolytic disease and a variety of disease states.

CRP has now come to be used as a marker or general diagnostic indicator of infections and inflammation, as well as a monitor of patient response to therapy and surgery.

The Hemagen High Sensitivity CRP Reagent is a latex in vitro diagnostic turbidimetric immunoassay developed to accurately and reproducibly measure CRP levels in serum and plasma samples. The assay has excellent functional sensitivity of 0.19 mg/L, with an assay range of up to 40 mg/L or 160 mg/L depending on the calibrator set used.

Method Comparison studies performed by one of the top reference labs in the country and Hemagen demonstrated a 0.996 correlation coefficient relative to the reference immunonephelometric method.

In a recent article published in Circulation: Journal of the American Heart Association, Renu Virmani, M.D., a researcher with the U.S. Armed Forces Institute of Pathology in Washington, D.C., said, "In the future, all patients should have their CRP levels checked. That way we can intervene with lifestyle counseling and drugs like statins and aspirin".

The total U.S. market for cardiovascular IVD testing products at the product supplier level was $900 million in 2000, the cardiac marker segment representing 15% (2001 Decision Resources, Inc.).

William P. Hales, President and CEO stated, "There is a definite trend in the medical community for performing High Sensitivity CRP tests as part of routine medical screening. We are pleased that through our R&D staff at Raichem we were able to have this product cleared. We expect to launch the product immediately with one of our large OEM customers, and have received inquiries from others."

Matthew Powell, General Manager of the RAICHEM division stated, "The assay adds significantly to our panel of turbidimetric immunoassay diagnostic kits. We are pleased with the FDA clearance of this product and expect substantial sales of this high quality, price-competitive assay."

Hemagen Diagnostics, Inc., is a biotechnology company that develops, manufactures and, markets more than 150 FDA-cleared proprietary medical diagnostic test kits used to aid in the diagnosis of certain autoimmune and infectious diseases.

In the United States, the Company sells its products directly to physicians, veterinarians, clinical laboratories and blood banks and on a private-label basis through multinational distributors of medical supplies. Internationally, the Company sells its products primarily through distributors.

Hemagen also manufactures and sells the Analyst(R) an FDA-cleared Clinical Chemistry Analyzer used to measure important constituents in human and animal blood. The Company sells the Analyst(R) both directly and through distributors servicing both physicians' office laboratories and veterinarians' offices. The company focuses on markets that offer significant growth opportunities.

The Company was incorporated in the Commonwealth of Massachusetts in 1985 and reincorporated in the State of Delaware in 1992.

Except for any historical information contained herein, the matters discussed in this press release contain forward-looking statements that involve risks and uncertainties, including those described in the Company's Securities and Exchange Commission Reports and Filings.

Certain Statements contained in this News Bulletin that are not historical facts constitute forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, and are intended to be covered by the safe harbors created by that Act.

Reliance should not be placed on forward looking statements because they involve unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to differ materially from those expressed or implied. Any forward-looking statement speaks only as of the date made.

The Company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date on which they are made.

Statements concerning the establishments of reserves and adjustments for dated and obsolete products, write-offs of goodwill, relocation expenses, expected financial performance, on-going business strategies and possible future action, which Hemagen intends to pursue to achieve strategic objectives, constitute forward-looking information.

The sufficiency of such charges, implementation of strategies and the achievement of financial performance are each subject to numerous conditions, uncertainties and risk factors.

Factors which could cause actual performance to differ materially from these forward looking statements, include without limitation, management's analysis of Hemagen's assets, liabilities and operations, the failure to sell date sensitive inventory prior to its expiration, the inability of particular products to support goodwill allocated to them, competition, new product development by competitors which could render particular products obsolete, the inability to develop or acquire and successfully introduce new products or improvements of existing product costs and difficulties in complying with laws and regulations administered by the U. S. Food and Drug Administration and the ability to assimilate successfully product acquisitions.