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II.  Executive Overview



The outlook for new in vitro diagnostics (IVDs) for

cardiovascular diseases has never been brighter.  Several trends

are converging to make the prospects for new cardiovascular IVDs

especially promising: recognition that cardiovascular disease is

a growing worldwide problem; dissatisfaction with currentdiagnostic 

methods; scientific advances that have linked

substances in blood and, increasingly, genetic factors to

cardiovascular disorders; and new treatment approaches that

require quick and accurate diagnosis, along with regular

monitoring of patients' responses to follow-up therapies.



Relative to other types of disease, cardiovascular disorders

are actually becoming somewhat less important than they used to

be in the industrialized world.  In 1985, cardiovascular disease

accounted for some 51% of deaths in the industrialized nations;

by 1997, the fraction had declined to 46%.  Nevertheless,

cardiovascular disease remains by far the most important health

problem in these countries.  And in the rest of the world,

cardiovascular disease is rapidly displacing infections and

malnutrition as the most important killers: it accounted for 24%

of deaths in 1997 in less developed countries, up from 16% in

1985.



     This change reflects increasing affluence, which often means

more animal fat in the diet, greater rates of cigarette smoking

and less exercise, as well as longer lifespans that allow people 









V.  Products in Development



Introduction: Types of Products



Cardiovascular IVD products fall into two main categories:

those for diagnosing ongoing events such as heart attack and

monitoring the patient's current condition, and those for

assessing risk for future events.  The latter is clearly the

biggest growth area. Most ongoing cardiovascular disorders and

events are already relatively easy to diagnose with current blood

tests, imaging and electromonitoring devices, although of course

there is plenty of room for improvement.  Identifying patients at

heightened risk for serious cardiovascular events, on the other

hand, is still in its infancy.  Standard tests such as

cholesterol analyses are effective as far as they go, but they

are fairly non-specific, pointing to only one early-stage factor

in the development of cardiovascular disease.  Research --

especially in the gene-hunting field -- is progressing rapidly on

other aspects of heart and vascular disease.  This is leading to

whole new classes of IVDs to identify patients at special risk

for heart attacks as well as chronic cardiovascular problems such

as hypertension and heart failure.











Organizational Activities



American Biogenetic Sciences Inc. (Boston, MA)



ABSI is focusing on a target it calls Thrombus Precursor

Protein (TpP), a proprietary name for soluble fibrin.  As its

name suggests, the fibrin protein forms long, thread-like

structures.  These are one of the most important components of

blood clots.  Prior to actual clot formation, soluble fibrin

complexes begin to appear in the blood.  These are the target of

two TpP assays marketed or in development at ABSI.  One is an

immunoassay for use in clinical labs, recently introduced to the

U.S. market.  ABSI has also begun a program, in collaboration

with New Horizons Diagnostics Corp. (Columbia, MD), to adapt the

assay to a rapid point-of-care product.  ABSI and New Horizons

are attempting to develop a hand-held device that will measure

soluble fibrin levels in five minutes.  A prototype has been

developed.  ABSI maintains business offices in Copiague, NY,

while its research and development is headquartered in Boston.



American Society of Hypertension (New York, NY)



Researchers at the Society and elsewhere have found a

statistical association between high plasma renin levels and

incidence of heart attack in white men.  Renin is well known to

be associated with hypertension; how it might have an independent

effect on the development of acute thrombotic conditions is not

clear.  Interestingly, the relationship was non-existent or less

pronounced for other patient groups, including women,

African-Americans and younger patients generally.  Plasma renin

tests are already routinely available but predicting heart attack

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