Hemagen Diagnostics Inc. has received FDA clearance to market aclinical diagnostic test used in the diagnosis of systemic lupuserythematosus, commonly known as lupus.

The test, which detects and measures antibodies to DNA in humanblood, completes the company's core line of rheumatology testsproduced in the ELISA format, Myrna Franzblau, treasurer of humanresources at Hemagen, told BioWorld Today.

"We now market more than 100 FDA-cleared proprietary medicaldiagnostic test kits," Franzblau said, "used to aid in the diagnosis ofautoimmune and infectious diseases and to measure importantconstituents in human blood."

Hemagen was founded in 1985 by Carl Franzblau, a biochemist atBoston University. The company went public in 1993.

Myrna Franzblau said the last several years have been profitable forthe company and next year looks even better. "We did $10 million inrevenues this year," Franzblau said, "and expect to do $13 millionnext year."

Hemagen's products use three basic technologies: ELISA,immunofluorescence and hemagglutination, which are sold under theHemagen and VIRGO labels. The principal difference between theELISA tests and the hemagglutination-based tests is thehemagglutination assays do not require an instrument, while ELISAtests are designed to be performed on instruments. Consequently,ELISA tests are often used in laboratories where high throughput isimportant, Franzblau said.

Hemagen produces approximately 40 different assays, which are usedin clinical laboratories and blood banks in the Americas, Europe,Asia and Africa.

The company, based in Waltham, Mass., has a production facility inColumbia, Md and a subsidiary in Sao Paulo, Brazil.

In October, Hemagen purchased Cellular Products Inc., of Buffalo,N.Y., for $600,000. The deal called for Hemagen to take overCellular's 15,000-square-foot factory and keep at least 75 percent ofCellular's 14 employees. Cellular manufactured its own blood-testingkits and other research products.

The Cellular purchase brought Hemagen's payroll total to 114employees. Hemagen, which makes approximately 100 test kits underits own label and private-label kits for some international customers,will make some of the raw materials for its kits at Cellular, instead ofbuying them from outside suppliers.

The next step for the recently cleared lupus test, Franzblau said, "is tosell the test in the U.S." The price of the kit, Franzblau said, has yetto be determined. n

-- Frances Bishopp

(c) 1997 American Health Consultants. All rights reserved.