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The first male infertility home test kit available without a prescription has been cleared for marketing by the FDA. The test indicates when sperm cell counts fall below a certain level--a potential indicator for male infertility.

The FertilMARQ Home Diagnostic Screening Test for Male Infertility stains cells in the sperm sample to produce a color. The color is then compared to a reference (chart/guide) on the test kit. The color comparison tells the user whether the sperm cells in the sample are positive--above 20 million per milliliter (/mL) or negative--below 20 million/mL. However, because this is a screening test, a positive test is no guarantee of infertility, meaning that other factors may be involved. Users should confirm test results with their physicians.

Embryotech Laboratories Inc., of Wilmington, Mass., makes the FertilMARQ test kit, which was cleared for marketing in August.

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