FDA okays OTC (over-the-counter) male fertility test:
This article was originally published in Clinica
Embryotech Laboratories has received US FDA 510(k) clearance to market an over-the-counter home screening test for male infertility. The FertilMARQ test provides quick and easy assessment for sperm concentration, based on WHO guidelines. It involves a simple procedure and produces a qualitative result within minutes, says the Boston, Massachusetts firm. The test will initially be marketed as a "stand-alone" male fertility test and, pending a final FDA review, as part of a joint "his-and hers" fertility test.