Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: TUESDAY, August 30, 1994 TAG: 9408300084
SECTION: NATIONAL/INTERNATIONAL PAGE: A-12 EDITION: NEW RIVER VALLEY
SOURCE: Los Angeles Times
DATELINE: WASHINGTON LENGTH: Medium
Although the FDA previously approved the blood test in 1986 to aid patients being treated for prostate cancer, Monday's approval is the first endorsement of its use for diagnostic purposes when used in conjunction with a rectal exam.
FDA officials cautioned that the test, a prostate-specific antigen procedure, should not be relied on exclusively to determine whether a man has prostate cancer. Rather, it should be used to complement a digital rectal exam by a physician, officials said.
Federal approval of the test developed by Hybritech Corp. of San Diego, a unit of Eli Lilly & Co., was based on a review of clinical studies on safety and effectiveness submitted by Hybritech and on the recommendation of FDA's immunology devices panel.
In a study of more than 6,300 men, the panel said that PSA blood testing combined with a rectal exam was much more effective in detecting prostate cancer than either a rectal exam or a PSA test alone. But a final diagnosis always requires a biopsy, the panel said.
With a small vial of blood drawn from a man's forearm, the test measures the level of a protein called prostate-specific antigen that circulates in the bloodstream. When these antigens are found at elevated levels, they signal prostate cancer, benign prostatic hyperplasia or other prostatic problems, physicians said.
According to the National Cancer Institute, 27 percent of all U.S. cancer cases involve the prostate. About 38,000 men die from prostate cancer annually. The institute estimated that 200,000 new cases will be diagnosed this year, as numbers have grown along with better diagnostic techniques.
Prostate cancer, in fact, is the most common malignancy among U.S. men and the second leading cancer killer, after lung cancer.
Memo: Shorter version ran in Metro edition