The federal government opened a new market worth millions of dollars Sunday when the Food and Drug Administration announced its approval of the first commercial test to screen blood for antibodies to AIDS (acquired immune deficiency syndrome).
Three local companies hope to compete for a share of that market, estimated to be worth $60 million to $80 million a year. But industry analysts say the lion's share will go to pharmaceutical giant Abbott Laboratories of North Chicago, the first firm to win federal approval for its test.
Abbott, the nation's major producer of medical diagnostic products, began delivering the test to its first customers Sunday afternoon, shortly after receiving federal permission.
Four other concerns have been licensed by the government to develop the test for commercial use, and now await Food and Drug Administration approval to begin selling it.
Electro-Nucleonics Inc., of Columbia, Md., has inventory ready and expects to receive FDA permission to begin shipments of its test this week.
The other firms awaiting FDA's verdict are: Litton Bionetics Inc. of Kensington; Biotech Research Laboratories Inc. of Rockville (jointly with E. I. du Pont de Nemours & Co. of Wilmington, Del.); and Travenol-Genentech Diagnostics of Cambridge, Mass.
Industry analysts expect Abbott to dominate the new market because of its established presence in the diagnostic field and the strength of its sales network.
"Abbott has a strong marketing position and a national reputation," said said Harold N. Chefitz, a biotechnology analyst with Swergold, Chefitz & Sinsabaugh Inc. "Abbott will dominate the field, but it will mean relatively little to Abbott's bottom line."
With 1984 sales of $3.1 billion, Abbott views its test more as a research success and an expansion of its product line than as a major new source of revenue.
To Biotech Research Laboratories, a small biotechnology firm, even a small share of the new market could be "extremely significant" in its efforts to return to profitability this year, said President Thomas M. Li. In the first nine months of last year, the firm lost $758,000 on sales of $2 million, primarily because of product development expenses, he said.
Electro-Nucleonics, which recently reported sales of $25.7 million for the first six months of its fiscal year, sells tests that screen blood for hepatitis, said Alan M. Fishman, a vice president and corporate spokesman.
"We're not new to the blood bank market," Fishman said, adding that the the new test for the AIDS antibodies is "quite important to us."
Fishman said Abbott "is obviously quite a strong competitor." But Electro-Nucleonics believes it has a "significant advantage" because of the accuracy of its test.
The new product detects the presence in the blood of antibodies to the virus believed to cause AIDS. The test does not detect the presence of the virus. However the presence of these antibodies indicates that the person tested has been exposed to the virus or a related virus.
The nation's 2,300 blood banks want to use the test to screen blood for the 3 million people who receive transfusions each year. The banks will destroy blood found to contain the AIDS antibodies.
Abbott said its test will sell for $2 to $3, depending on the volume of sales, and estimates the total market to be about 1.6 million tests per month, just in the United States.
About 1 million tests per month will be sold to blood banks, and the rest will go to plasma centers and commercial laboratories, said David C. Jones, a vice president and spokesman for Abbott.
More than 90 percent of the nation's blood banks use an Abbott instrument, called a Quantum, to screen blood for hepatitis. The Quantum can now be used to process the new test for AIDS antibodies, Jones said.
Abbott's scientists are working now to develop a test to identify the presence of the AIDS virus itself, Jones said. "There's a lot left to do.