Biocoat Inc., an R&D company specializing in biomaterials coatings for medical device applications, has introduced their new HBA Sperm-Hyaluronan Binding Assay. It is anticipated that this fast, simple, inexpensive in vitro diagnostic test of sperm function will revolutionize the diagnosis and treatment of male infertility. It should also help determine the best course of treatment when assisted reproductive technologies are indicated.

The patented assay is based on research conducted by Dr. Gabor Huszar of the Yale University School of Medicine. He discovered that a sperm cell that binds to hyaluronan is mature and has the capability to bind to and fertilize an egg. Sperm that does not bind is unable to fertilize and is likely to have other defects, including chromosomal abnormalities and reduced DNA integrity.

A 510 (K) exemption has been filed with the FDA. The marketing and distribution of the new assay will be handled by Mid Atlantic Diagnostics, Inc. in Marlton, NJ.