For Infornation:
Andrqp Jowers
llanager, News Bureau
(619)457-82W, 455-8133
FOR II'$IDIAIE
#060988-6
REIEASE
IA JOLIAT ,June 9 -- The U.S. Food and Drug Adninistration
qmthetic-peptide
approved for sale the first
a six-minute
Institute
test
diagnostic
medical product,
for infecticr.rs mononucl-eosis developed at the Research
and Johnson & Johnson.
of Scripps Clinic
Ttre assay uses a nnn-nade peptide to detect
Epstein-Barr
tras
the cause of infectious
virus,
a sequence of 19 amino acids,
identical
antibodies
to the
nrononucl-eosis, The peptide is
to a sequence fcund in an Epstein-
Barr viraL protein.
"The abil-ity
only a snnll
to detect viral
slznthetic piece of the virus,
amino acids, is a significant
associate
infection,
director
especially
comnercially'
with such a short stretch
with
of
achievsnentr" said Dr. William Beerst
of the Research Institute.
The technology can be used in the diagnosis of other viral
infections,
bacterial
infections
in treatment by slmttretic
prograns director
and autoimmune diseases, and, evertually'
vaccines,
said Dr. E11iot Parks, diagnostic
at the JaJ Biotechnology Center in Sorrento Valley.
(llore)
Page 2
June 9, 1988
#060988-6
Indeed, several nrore Johnson & Johnson diagnostic
Scripps Clinic
approval this
products using
technology are being developed and may be given FDA
year, Parks said.
Research Institute
investigators
identified
the slznthetic peptide,
in 1983, constructed
the amino acid sequence
and licensed
the technoloqz to
Johnson & ,lohnson. The peptide was developed as a corunercial- test
by the
J&J Biotechnology Center.
Research Institute
involved in the project
investigators
include
Drs. Dennis Carson, Gary Rhodes and John Vaughan, basic and clinical
research departrnent, and Dr. Richard Houghten' molecular biology
deSnrtment.
Tlae researchers,
when studying the possibl-e role of the Epstein-Barr
noticed an unusual sequence of anjno acids
in rheunntoid arthritis,
virus
in Ltre viral
protein.
lrJhile most proteins
several of the approxinately
protein
has a I9-amineacid
20 varieties
fight
that
the EpsteirBarr
The qmthetic
acute antibodies,
the Epstein-Barr
amino acids.
reslnnded to that squence of 19 anino
said Rhodes. "Those antibodies
off
of amino acids'
sequerce with only b,vo different
"We l-ooked for antibodies
acidsr"
have sequerces containing
were those t}re body produces to
virus."
peptide binds to and detects two antibodies:
that are the first
or convaLescent antibodies,
to appear after
infection;
that aplEar l-ater and nny last
l-ifetime.
(l"1ore)
IgPl' or
and IgGT
the lntient's
Page 3
June 9, 1988
#060988-6
If
shows a greater
the assy
reslDnse by IgIl antibodies
than by IgG
the Sntient has npnonucleosis. If the IgG antibodlz restrnnse is
the trntient has had previo.rs exlDsure to the g>stein-Barr virus
antibodies,
greater,
and is probably irmune from contracting
rnononucleosis if
reexposed.
The assay - known as Ortho t"lonolert and narketed by Ortho Diagrnstic
Systens, a Johnson & ,Johnson sdcsidiary based in Raritan, N.J. - is the
product to reach the narket as a result
first
of a 1983 agreement between
Scripps C1inic and Johnson & Johnson.
Under ttris agreement, the pharnaceutical
in return
investigations
applications
for first-refusal-
rights
more sensitive,
two yearsr rather
tests are thaL it
synptcrns similar
in drildren,
especially
is
has a shelf life
of
gives trntients nprecorclusive
or leuksnia, two diseases with
than a fer weeks, dnd it
evidence that they donrt have hetrntitis
to those of nrononucleosis.
of 299 specimens, l"lonolert proved 98.8 trrercent
test
on corrfirmed cases of mononucleosis, while the traditional
In clinical
sensitive
on comnercial
of technology developed at the Research Institute.
Advantages of the assay over existing
significantly
comlEny funds basic
trials
gave false negative results
on 15 lnrcent
of crrnfirmed casesr according to
Orttro Diagnostics.
About 10 percent to 20 percent of the U.S. population
contracts
fever,
infectious
sore throat
aged 15 to 21
nrcnonucl-eosis' "the kissing diseaser" rarked by high
and svelling
of the lymph nodes. l.lore than 90 percent
of U.S. adults have been extrnsed to the @stein-Barr
have detectible antibodies.
+.$+
lt ti lt
virus'
ard therefore