FDA OKs Blood Test for Heart Disease Risk
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WASHINGTON - Doctors are getting a new blood test to
help predict which people with low cholesterol are at
risk for heart disease.
The Food and Drug Administration (news - web sites)
approved the PLAC test Friday. It works by measuring
an enzyme active in the inflammatory process, one
known as Lp-PLA2.
In a federally financed study, researchers tracked
more than 1,300 middle-aged people for nine years to
see who was most at risk of developing heart disease.
Of most interest were people considered at very low
risk of heart disease because they had normal levels
of the so-called bad cholesterol, or LDL cholesterol —
levels below 130.
When those low-cholesterol patients had high levels of
Lp-PLA2, however, they were twice as likely to develop
heart disease, said lead researcher Dr. Christie
Ballantyne of Baylor College of Medicine.
Add another measure of risk — a separate inflammatory
protein called C-reactive protein — to a high Lp-PLA2
level, and the risk of heart disease tripled, he said.
Between one-third and half of heart attacks occur in
people who do not have high cholesterol, so scientists
have long hunted ways to find which of those people
were at risk in time to help them.
The PLAC test promises to be one tool to do that,
Ballantyne said.
The laboratory test is made by diaDexus Inc. of San
Francisco. The company wouldn't reveal a price but
said it would be competitive with testing for
C-reative protein, which is roughly $16.
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