MARKERS FOR OSTEOARTHRITIS

Release Date:  March 17, 1999

RFI AVAILABLE:  NIH-NIAMS-RFI-99-03

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) is seeking sources who have the capability to a) propose potential
biochemical markers for osteoarthritis and b) develop, validate, and 
standardize sensitive assays for osteoarthritis markers in body fluids or
tissue specimens.  Osteoarthritis is the most prevalent musculoskeletal
disorder, characterized by joint pain, tenderness, and functional disability. 
The percentage of Americans over 65 years of age is the fastest growing
segment of the population, which is expected to reach 68 million people by the
year 2010.  A test for a biochemical marker for osteoarthritis would be
particularly useful for early detection, assessment of disease severity and
progression or to monitor the effects of therapies.  Biomarkers and surrogate
endpoints of disease are the focus of an April 15-16, 1999 conference
cosponsored by the National Institutes of Health (NIH) and the U.S. Food and
Drug Administration (FDA).  This forum will emphasize research needs and
scientific opportunities to develop and apply biomarkers for safety and
efficacy evaluations of novel disease interventions.  Markers of joint
destruction and repair in osteoarthritis, rheumatoid arthritis, and ankylosing
spondylitis is one of the topics that will be addressed.  More information
about this conference is located at the following web address: 
http://www4.od.nih.gov/biomarkers/.

Advances in the molecular biology, biochemistry, and metabolism of cartilage
have stimulated the quest for appropriate markers of degradative and
regenerative processes in osteoarthritis.  In the early stages of
osteoarthritis there are marked increases in the catabolism and anabolism of
the major cartilage extracellular matrix macromolecules.  Important new
studies indicate that molecular fragments and metabolites of cartilage-derived
matrix molecules are present in the blood and joint fluid in osteoarthritis
that have the potential to represent disease-specific markers.  The increased
rates of cartilage degeneration increase the concentration of matrix
components in tissue and body fluids, thus reflecting changes in the rates of
cartilage catabolism.  Further, changes have been reported in the type or
structure of the molecules being newly synthesized by the chondrocytes.  Thus,
catabolic and anabolic neo-epitopes may be useful markers of metabolic events
within the tissue.  Markers of metabolic changes in subchondral bone or other
joint tissues in osteoarthritis is also of potential interest.

Interested sources should provide information addressing the specific
technical issues and the capabilities required to undertake this project,
including:

o  Existing and new biomarkers for osteoarthritis and their potential
significance as surrogates for onset, severity or progression;

o  The potential methodologies for detection, including production and
characterization of reagents and assay systems;

Responders may also wish to consider including information about:

o  The anticipated scope of the validation phase to correlate marker
concentration to clinical manifestations of osteoarthritis; 

o  The specimen requirements, including identification of tissue or body fluid
to be screened, sample amount required, numbers of samples required, and
procedures for management and handling of samples; 

Interested parties should submit a response not to exceed 10 pages addressing
the information requested above and summarizing the ability to perform all
aspects of the effort described herein.  Responses are due by April 19, 1999. 
Responses will be reviewed only by NIH personnel and will be held in a
confidential manner.  All proprietary information should be so marked and will
be protected.  Responses may be submitted by for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, commercial organizations, units of State and local governments,
and eligible agencies of the Federal government.  Collaborative arrangements
between the public and private sector are especially encouraged.

This announcement is a Request for Information (RFI).  The purpose of this RFI
is to (1) permit the NIAMS to collect information on the spectrum of markers
of potential high value for testing in human patient populations, (2)
determine the number of organizations capable of testing for a biochemical
marker for osteoarthritis, and (3) obtain valuable information that can be
used in the development of any future announcements or solicitations if
appropriate.  All organizations responding to this RFI will receive a copy of
any resultant announcement or solicitation.  The Government does not intend to
award a contract on the basis of responses nor otherwise pay for the
preparation of any information submitted or the Government's use of such
information.  However, should such a requirement materialize, no basis for
claims against the Government shall arise as a result of a response to this
synopsis or the Government's use of such information as part of the evaluation
process or in developing specifications for any subsequent requirement.

This requirement is listed under Standard Industrial Classification SIC Code
8731.  All respondents are asked to indicate the type and size of their
business organization in their response.

INQUIRIES

Inquiries may be directed to:

Valerie M. Syed
Contracts Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Disease
Building 45, Room 5AS13A
Bethesda, MD  20892
Telephone:  (301) 594-2543
FAX:  (301) 480-5996
Email:  vs25o@nih.gov

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