ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, September 28, 1996 TAG: 9609300053
SECTION: NATIONAL/INTERNATIONAL PAGE: A-4 EDITION: METRO
Pap results not left up to computers
WASHINGTON - A machine used to double-check whether women have signs of cervical cancer isn't good enough yet to replace the people who perform those tests, scientific advisers told the government Friday.
Some 60 million Pap smears are performed every year to detect cancer and pre-cancerous changes in the cervix, tests that help thousands of American women learn they have cervical cancer early enough to cure it.
But studies indicate that laboratory technicians can misdiagnose up to a third of Pap smears, when they miss tiny changes in the hundreds of thousands of cells they visually examine every day.
Last year, the Food and Drug Administration approved two computer systems that promise to double-check Pap smears to better ensure that the technicians didn't miss any cancer.
Now, NeoPath Inc. wants to go the next step and have its AutoPap computer replace humans for the third of Pap smears the company contends are most easily classified as normal. NeoPath studied 700 Pap specimens and found that humans missed 173 that were abnormal while the machine missed just 37.
But the FDA's outside advisers said NeoPath was good at detecting one type of cervical cancer, but didn't prove it was as good as humans at finding the pre-cancerous cervical changes, commonly called dysplasia, that offer women the best hope for a total cure.
``If you make a 1 or 2 percent error and apply that to 60 million Pap smears a year, that's a whole lot of additional mistakes,'' said panel chairman Dr. Timothy O'Leary of the Armed Forces Institute of Pathology, before the group voted 8-1 to reject NeoPath's request.
The FDA is not bound by its advisers' recommendations but usually follows them.
- Associated Press
Blood product for dialysis recalled
Centeon, a King of Prussia, Pa., company is recalling 17,000 vials of human albumin, a blood product commonly used in dialysis treatment, because it appears contaminated with dangerous bacteria. The Food and Drug Administration has learned of two patients who survived blood poisoning after receiving the albumin, sold under the brand name Albuminar.
Only one lot of the albumin - lot P61205 - is contaminated and being recalled, according to Centeon. For more information, Centeon can be reached at (800)504-5434.
- Associated Press
LENGTH: Medium: 52 linesby CNB