Subject: AIDS Blood Test Nears Completion By Drug Concerns
Date: Published: 1/14/85 92 lines
Source:  Wall Street Journal.  Copyright Dow Jones Inc. 

   AIDS Blood Test
   Nears Completion
   By Drug Concerns
    ---
   Government License Sought
   To Market Lab Process
   For Detecting Disease
    ---
   By Marilyn Chase
   Staff Reporter of The Wall Street Journal

   More than half a dozen companies are racing toward the
home stretch in a contest to market a blood test for acquired
immune deficiency syndrome, or AIDS. 
   AIDS, a deadly disease spread by sexual contact or
contaminated blood products, has killed about 4,000 of the
8,000 Americans who have contracted it.  More than 100 of
those cases have been linked to blood transfusions.
   Last April, Robert C. Gallo of the National Cancer
Institute announced the isolation of a virus, HTLV-III, as
the probable cause of AIDS. As reported, the U. S. Public
Health Service licensed five companies to produce the blood
test and it was predicted that it would be produced in about
six months.  However, nine months have passed and the number
of transfusion-linked cases has mounted.
   One company, the Litton Bionetics unit of Beverly Hills,
Calif.-based Litton Industries Inc., says it is only a few
weeks from marketing approval for its test, which is called
Bio-Enzabead.
   "We expect to be licensed by the Food and Drug
Administration by the end of the month," said Ray Noble, a
spokesman for the parent.  He said the FDA currently is
inspecting two manufacturing plants in Kensington, Md., and
Charleston, S. C. He added that the $2 test will be
distributed to blood centers by Ortho Diagnostics Systems
Inc., a unit of New Brunswick, N. J. -based Johnson & Johnson.
   "There's a lot of rumors as to who's where," said John
Kay, Litton's product manager for the AIDS test.  "Our eyes
are on the tape and I'm not going to let the guys in the
other lane distract me."
   Litton's test uses plastic-coated metal beads that are
covered with a viral protein that is dipped in a blood
specimen.  If the blood contains an antibody to the AIDS virus
 -- indicating exposure and possible infection -- the antibody
will stick to the protein-coated bead.  A green halo on the
bead signals a positive test.  The test takes about two hours
and can be performed by a lab technician.
   The test's process, known as an ELISA (or enzyme-linked
immunosorbant assay), uses an "inactivated" virus believed to
be non-infectious.  Mr. Kay said the tests will be processed
by a semiautomated magnetic process "to limit human
handling."
   The other federal licensees include Abbott Laboratories,
North Chicago, Ill.; Electro-Nucleonics Inc., Fairfield,
N. J. ; Travenol/Genentech Diagnostics, Cambridge, Mass., a
joint venture of Baxter Travenol Laboratories Inc. and
Genentech Inc. ; and a joint venture of Biotech Research
Laboratories Inc. of Rockville, Md., and Du Pont Co. of
Wilmington, Del.  Companies that are developing tests without
federal help are Genetic Systems Inc. of Seattle, and Chiron
Corp., of Emeryville, Calif., whose test uses recombinant
DNA. 
   Biotech's Robert Ting said the Biotech-Du Pont venture
"should have its test on the market by the end of February."
Sean O'Neill of Electro-Nucleonics said that company's test
"is moving ahead rapidly ...  but we're restricted by the
FDA from saying things that could be viewed as promoting the
product."
   Abbott Laboratories has finished clinical trials and is
about to apply for a product license, a spokesman said.
Jacques Fonteyne, president of Travenol/Genentech
Diagnostics, said the venture needs another two to three
weeks of clinical tests before applying for a product
license.
   Blood-bank officials estimate that testing the 12 million
units of blood donated each year could cost $60 million to
$120 million.  But companies deny they're in it for the money,
with Litton's Mr. Noble saying his company seeks "just the
aura of being able to do it."
   Marketing the tests is likely to be low key.  "You don't
need to be creative with something like this," said Mr. 
Fonteyne of Travenol/Genentech.

(This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.)