ROCKVILLE -- A small company hoping to market a do-it-yourself Pap test kit to detect cervical cancer saw its hopes dashed yesterday by a panel of the Food and Drug Administration, although panelists applauded the applicant's goal of reaching disadvantaged women.
The Obstetrics-Gynecology Devices Panel voted 4-2 to recommend FDA disapproval of a plastic tubular device called My-Pap, which drew controversial testimony from the lay public and the medical profession.
Panelists said that Medtech Inc. of Bohemia, N.Y., did not prove that its test would be used by the target group of women and also questioned whether the results would give users a false sense of security. The test has a high rate of incorrect results.
Two panel members wanted to approve the device while restricting its use to populations underserved by the health-care system.
"It's better than nothing," said Dr. Washington C. Hill of Meharry Medical College in Nashville, Tenn.
About 5,500 American women die of cervical cancer each year, largely for lack of examinations.
Dianna Truglio, president of Medtech, told the panel she is committed to "bringing early detection to women who don't have easy access to health care." For the past five years, she said, she has been working to bring mammography vans to workplaces and poor areas to get women examined for breast cancer.
Similarly, she said, the home Pap test kit, which would have been available by prescription only, is for women who don't see a doctor for regular Pap smears. The sample would be mailed to a laboratory for testing.
Dr. Howard Jones III, chairman of the obstetrics and gynecology department at Vanderbilt University in Tennessee, and several other physicians and cytopathologists testified about the results clinical trials of My-Pap they conducted during the past five years.
Dr. Jones said that 1,765 kits were distributed to women at three medical centers or clinics and that 80 percent were returned.
The accuracy of the tests is about 80 percent that of the standard Pap smear done in a doctor's office, according to Dr. William Rodgers, a cytopathologist at Vanderbilt.
"We find these limitations acceptable," said a spokesman for the National Women's Health Network, which urged FDA approval of My-Pap to help women not getting Pap smears.
However, Public Citizen Health Research Group, the College of American Pathologists and the American Society of Clinical Pathologists all opposed it.