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QuantRx gets FDA clearance for immunoassay test

QuantRx Biomedical has received FDA clearance for its follicle stimulating hormone lateral flow immunoassay test for the detection of follicle stimulating hormone at 10ng/ml.

The QuantRx biomedical female fertility test is a one-step lateral flow device that determines ovarian reserve indirectly by measuring follicle stimulating hormone (FSH) in first morning urine. The QuantRx biomedical female fertility test can produce results within 15 minutes and will now enable women to expeditiously determine if they should pursue further fertility evaluations.

Cindy Horton, vice president of diagnostics at QuantRx, said: “The new clearance allows the company to provide its customers with a new and innovative product for women’s health in the over-the-counter market.”