FDA approves home test kit for menopause: Experts question its value.

The Food and Drug Administration has approved the first-ever home urine test designed to help women determine if they have approached menopause.

But experts interviewed for this story questioned the value of the test, which is manufactured by Genua 1944 Inc., a Toronto-based company "I think someone at the FDA was out to lunch when they approved this test," said Dr. Wolf Utian, professor emeritus of obstetrics and gynecology at Case Western Reserve University, Cleveland.

Known as the Menopause Home Test, the product measures urine levels of FSH on a small absorbant pad and has demonstrated 99% agreement with lab tests for serum levels of FSH. The pad turns a pink-purple color when FSH levels reach 25 IU or greater, a level predictive of poor ovarian reserve.

The test is intended to increase women's awareness of menopause without the need for an office visit to obtain a serum FSH, said Dr. Aaron Tabor, a physician whose company markets the product for Genua.

A package of two tests sells for $59.95 and is available only from a Web site managed by Dr. Tabor's company Physicians Pharmaceuticals, Kernersville, N.C. (www.menopausehometest.com).

"With traditional FSH testing, you have to schedule an appointment with your doctor, take time off work, you get blood drawn, make your copayment, wait 3-4 days and likely come back to the physician's office---for which you have missed more work, and you have had to make another copayment," said Dr. Tabor, the company's CEO.

"By doing it at home, you save a lot of money and a lot of time. It's a lot more convenient," he said.