Subject: FDA Approves Five-Minute AIDS Test 
Date: Published: 12/14/88 105 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Technology:  
    FDA Approves Five-Minute AIDS Test
    Developed by Cambridge BioScience
    ----  
    By Christopher J. Chipello
    Staff Reporter of The Wall Street Journal

    BOSTON -- Cambridge BioScience Corp. said it received
 approval from the Food and Drug Administration to sell its
 five-minute diagnostic test for acquired immune deficiency
 syndrome.
    The approval marks an important development for AIDS
 testing world-wide.  Unlike currently available tests, the new
 product doesn't require laboratory instruments and thus could
 be administered in remote areas.  It also shortens testing
 time from the three hours or so now required -- a factor that
 can be crucial in certain situations, such as organ
 transplants.
    The test will be marketed in the U. S. and overseas
 exclusively by Baxter Healthcare Corp., a subsidiary of
 Baxter International Inc. Cambridge BioScience said the
 tests, which can be run on a drop of blood from a finger,
 could be used in doctor's offices, emergency medical centers
 or venereal disease clinics.  They will be priced at about $10
 each, depending on volume, and sales are expected to begin
 "within the next few weeks," said Gerald Buck, president and
 chief executive officer of Cambridge BioScience.  AIDS tests
 now are priced at $1 to $3 each, and are used mainly by blood
 banks.
    The approval marks a milestone for the young company.  At a
 news conference here, Mr. Buck said the Worcester, Mass.,
 biotechnology company expects to capture by the end of 1989
 10% to 15% of a market that currently is estimated at $100
 million to $200 million world-wide.
    In national over-the-counter stock trading, Cambridge
 BioScience's stock closed at $15.375, up 87.5 cents.  In New
 York Stock Exchange composite trading, Baxter's stock closed
 at $17.625, up 37.5 cents.
    Mr. Buck said clinical trials on more than 7,000 specimens
 at nine sites have shown that the five-minute test yields
 only 0.4% false negative readings and 0.4% false positive
 readings -- levels that he said are as good or better than
 currently available tests.
    The FDA said the five-minute test, the first approved AIDS
 test based on gene-splicing techniques, isn't intended to
 replace the current tests used by blood banks for screening
 donated blood.  "Furthermore, any positive reactions using
 this screening test must be confirmed because false-positive
 reactions can occur," FDA Commissioner Frank Young said in a
 prepared statement.
    Mr. Buck noted, however, the test would enable doctors to
 tell patients right away if they tested negatively for the
 virus.  For those patients testing positive, doctors would be
 advised to immediately repeat the test, he said.  After a
 second positive finding, a larger blood sample would be taken
 for further laboratory confirmation.
    Mr. Buck also said Cambridge BioScience is seeking FDA
 approval for a test to confirm a positive finding that can be
 done in just two hours, compared with 24 hours for the
 procedure commonly used.  Donald Reed, the company's chief
 financial officer, said the company hopes to receive approval
 for the two-hour test in 1989.
    Cambridge BioScience, a seven-year-old biotechnology
 company, has reported a string of large losses as it waits
 for its products to come on line.  For the first nine months,
 the company posted a net loss of $5.4 million on revenue of
 $3.2 million.
    Mr. Buck declined to project the impact of the five-minute
 test on the company's earnings.
    Teena Lerner, an analyst with Shearson Lehman Hutton Inc.,
 said the new test "is the product that's going to put
 (Cambridge BioScience) on the map, as a real company."
    Ms. Lerner said Cambridge BioScience appears to have a
 year's lead time over other potential makers of tests based
 on gene-splicing, such as Du Pont Co. and Abbott
 Laboratories.  Both are among companies that now offer
 so-called first-generation AIDS tests, based on materials
 derived directly from the AIDS virus.
    Baxter, based in Deerfield, Ill., said the test has been
 approved for sale in Sweden, Norway, Belgium, Switzerland,
 the United Kingdom, the Netherlands and Ireland.  Licenses for
 the test are pending in West Germany, France, Spain, Italy
 and Japan.  With FDA approval, the test now is available for
 export sales, according to Baxter, which will market the test
 through its Pandex division.
    A Baxter spokesman said the company "isn't counting on
 generous amounts of revenue" in 1989 from the sale of the new
 test.  The spokesman said one concern the company has is that
 doctors may avoid such quick tests because they might not
 want to tell patients face-to-face if they test positive.
    Mr. Buck said the sales price in Africa will be negotiated
 with the World Health Organization, to reflect the lower
 levels of income on that continent.  Mr. Buck didn't offer
 details on how sales to impoverished African nations would
 likely be handled, but said, "We'll be able to meet their
 needs, I'm confident."

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