Adapted from a news release from Beckman:
FDA APPROVES NEW "FREE PSA"
WASHINGTON D.C. [March 10] -- The Food and Drug Administration today approved a new blood test to enhance the accuracy of prostate cancer detection. The Hybritech Free PSA test is expected to significantly reduce the number of unnecessary prostate biopsies, lower health-care costs and ease the anxiety of many men over age 50 who are at risk for prostate cancer.
The Hybritech Free PSA test developed by Beckman Coulter detects 95 percent of prostate cancers and will be used by physicians to differentiate between prostate cancer and benign prostate conditions, said clinical researchers involved in a recent multi-center study.
Nearly all prostate cancers that are detected before the cancer has spread outside the prostate can be cured, according to the American Prostate Society.
The Free PSA test can reduce unnecessary prostate biopsies by 20 percent, reports the multi-center study headed by William Catalona, M.D., professor of urology at Washington University School of Medicine, in St. Louis. Men with free PSA of 0-10% of total PSA have the highest likelihood (56%) of having cancer. Those with 25% and above have only an 8% chance of cancer, according to Hybritech 's data. Hybritech set the cut-off for referral to biopsy at 25% free PSA.
Hybritech 's PMA was based on data from what the company called the largest study ever of the role of free PSA in diagnosing prostate cancer. The study included data from seven sites on 773 patients between the ages of 50 and 75. For men 50-59 years old, the test had sensitivity of 98%, and eliminated 11% unnecessary biopsies. For patients 60-69, the test was 94% sensitive and eliminated 19% unnecessary biopsies. For patients 70-75, sensitivity was 90%, and 34% unnecessary biopsies were avoided.
Dr. Catalona predicted that testing for free PSA will play a central role in the battle against prostate cancer. "Our research findings indicate that this test can help physicians more precisely detect prostate cancer in its early stages," he said. Prostate cancer is expected to kill more than 39,000 American men this year, according to the American Cancer Society.
"The Free PSA test is designed to be used as a follow-up to an initial test for total PSA, when that first test detects moderately elevated PSA levels," said Paula Southwick, Ph.D., of Hybritech Incorporated, a subsidiary of Beckman Coulter, the company that developed the new blood test. Before being acquired by Beckman Coulter, Hybritech also developed the first FDA-approved PSA test to detect prostate cancer.
Dr. Catalona's study found that the Hybritech Free PSA test detects 95 percent of prostate cancers, and that the cancers it misses are likely to be small and not life-threatening.
"The Free PSA test helps identify the patients who could really benefit from surgeries or other treatments," said Dr. Catalona. "The men who have the five percent of cancers not detected by this test generally are older and have low-grade tumors. The best course of action for these patients is often watchful waiting." The disease can progress slowly in older men.
Approval of the Hybritech test was heralded by Us Too, a national association of prostate cancer survivors. "This is a significant step forward in the battle against prostate cancer," said Roland Young, vice president of Us Too and himself a prostate cancer survivor. "Men don't want to be biopsied unless it is absolutely necessary, due to the expense, pain, anxiety and possible complications of a prostate biopsy. The Hybritech Free PSA test will spare many men that ordeal."
Members of the public who want more information on the Hybritech Free PSA test can call toll-free to (888) 880-0518.