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Abbott Laboratories Message Board

  • Rockville, Maryland, Sept. 17 (Bloomberg) --
    Abbott
    Laboratories' PRISM blood screening device could
    improve the
    safety of the U.S. blood supply and
    should be cleared for sale, a
    panel of experts
    said.

    The advisory panel for the U.S. Food and Drug
    Administration
    voted unanimously to recommend the full agency
    approve the
    device, for use in the blood screening
    done by hospitals, blood
    banks and by the
    companies that manufacture blood products.

    In
    backing the device, the panel followed the urging of

    representatives from numerous blood banks who said the
    machine
    cut down on thousands of manual steps each day at
    their testing
    centers, and eliminated the potential
    for human errors as well as
    negligence in the
    testing process.

    ``This will allow us to catch
    more infected donors while
    rejecting far fewer
    safe donors that must be deferred using the

    current tests,'' said Louis Katz, a spokesman for the
    America's
    Blood Centers, a national blood bank
    organization. ``From our
    review of the available data, the
    PRISM is virtually tamper
    proof.''

    Abbott
    is the 7th largest U.S. drugmaker by sales.


    Today's review of the PRISM device comes during a
    two-day
    panel meeting on blood products and amidst
    increasing concern
    about the safety of the blood supply.
    A recent report by the
    General Accounting
    Office -- a fact finding office for the U.S.

    Congress -- found that the FDA's safety guidelines for
    so-called
    plasma products are largely adequate but too
    often ignored or
    followed imperfectly by
    companies.

    Companies including Bayer AG, Alpha Therapeutics
    Corp.,
    Baxter International Inc. and Centeon LLC use
    plasma -- one
    component of the whole blood given in
    donations -- to produce
    essential treatments such as
    the immune system-boosting drug
    known as immune
    globulin.

    Manufacturing Problems

    Centeon is only
    the latest company to run into manufacturing

    problems. A joint venture of Germany's Hoechst AG and
    France's
    Rhone-Poulenc SA, the company was recently shut
    down by the FDA
    because it repeatedly failed to
    follow the agency's manufacturing
    safeguard rules.
    Centeon was also forced to suspend operations at
    two
    different times in 1996 and 1997 because of manufacturing
    and
    contamination problems, one of which led to FDA
    investigations
    into at least 12 cases where people may have been
    infected by
    tainted Centeon blood products.


    The PRISM is a piano-sized machine that regulates
    the
    testing process and can detect a full range of
    possible blood
    contaminants including hepatitis and
    HIV, Abbott said.

    FDA members told the panel
    they expect the FDA's final
    review of the device
    to be completed by Oct. 20.

    While the device
    would be a boon to blood banks and could
    enhance
    the safety of the blood supply, an approval is
    unlikely
    to significantly affect the company's overall
    sales, analysts
    said.

    Still, the panel
    backing represents a win for Abbott, which
    has lost
    its dominance in blood screening devices, as Johnson
    &
    Johnson and others have build their presence in
    the market.

    ``It really gets Abbott back on
    the high ground, and it's
    probably got more
    commercial appeal than people think,'' said
    Daniel
    Lemaitre, an analyst with SG Cowen Securities Corp. In

    terms of a psychological boost for the company, ``This
    is a huge
    win,'' he said.

    The device is
    already used in Europe and the Pacific Rim,
    company
    officials said.

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    • Manual Tests

      Currently, the safety and
      purity of the U.S. blood supply
      depends upon a
      series of manual tests run on each individual
      blood
      donation. The FDA requires blood processing labs to
      follow
      a system of checks and balances during this
      testing
      process.

      Called Good Manufacturing
      Practices, or GMP, the system is
      designed to safeguard
      against mistakes along the way. It is, by
      nature,
      dependent on the careful participation of companies and

      on the avoidance of human error.

      For
      example, laboratory technicians must check and double-

      check that the right amounts of the right chemicals are
      used in
      thousands of tests, and document every
      step.

      Any breakdown in GMP offers to compromise the
      safety of the
      blood supply regardless of whether a
      unit of blood is actually
      contaminated.


      ``These represent thousands of incidents each year that
      are
      investigated by the industry and FDA,'' said
      James Stewart, who
      presented data on the device for
      Abbott. ``Behind these lies the
      possibility that
      there are many (more) incidents which go

      unreported.''

      Automated Process

      The PRISM automates
      this entire process, cuts down on the
      sheer number
      of manual steps -- by about 65 percent -- and

      reduces the potential for mistakes, he said.

      And
      because it takes much of the uncertainty out of this

      process, the company projected the device could prevent
      the
      unnecessary re-screening tens of thousands of
      units of blood each
      year, Abbott said.


      ``This technology offers a significant public health

      benefit,'' Stewart said.

      Finally, company officials
      said the machine is more
      sensitive than some
      existing tests. For example, it can detect
      some
      viruses about a week earlier in the course of an
      infection
      than current tests. That may lessen the chances
      of tainted blood
      reaching the blood
      supply.

      Lag Time

      There is a short period after
      infection before the body
      musters specific antibodies
      -- which is what most screening test
      look for --
      for a particular virus. That lag time is the
      reason
      donation centers don't accept blood from donors
      who have recently
      gotten a tattoo, engaged in
      unsafe sexual practices or who carry
      other risk
      factors. Sensitivity to contamination sooner after a

      donor has been infected narrows the possible window for
      an error.

      The panel vote came after the
      close of trading on U.S.
      markets. Shares in Abbott
      Park, Illinois-based Abbott fell 9/16
      to close at
      42 9/16.

      The FDA generally follows the
      advice of its expert
      government panels, but is not
      required to do so.

 
ABT
42.89-0.08(-0.19%)Jul 24 4:02 PMEDT

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