SBIR-STTR Award

The rabbit is a valuable model for reproductive toxicity studies and is especially useful for acute chronic, and reversal studies in the male. Its semen is difficult to analyze in computer systems due to the presence of particles easily mistaken for nonmotile sperm. This project will develop a prototypeautomated analyzer for objectively evaluating rabbit (and other) semen, in which the errors caused by interfering granules and by high sperm velocity are eliminated. This prototype will use a stroboscopic phasecontrast optical system specially adapted both to discriminate between sperm and granules and to reduce velocity-induced image blurring to insignificant levels. Morphometric analysis will also be used as an additional discriminator if necessary. The critical experiments to validate the algorithms for granule discrimination will be performed by harvesting granules and adding them back, in known amounts, to granule-free, pooled semen samples. With these improvements, it should be possible to accurately, conveniently, and rapidly determine sperm concentration, motility, and velocity.Awardee's statement of the potential commercial applications of the research:This analyzer will have wide applications in the toxicological field for determining the reproductive effect of toxic substances, with the market estimated at 1,200 sites worldwide. It will also be very useful in the analysis of human sperm.National Institute of Environmental Health Sciences (NIEHS)

This project focuses on computer aided sperm analysis (CASA) technology for the analysis of sperm motion. In Phase II, the technological accomplishments of the prototype system tested in Phase I will, with certain innovations,(1) be upgraded into a clinical instrument,(2) be validated and(3) be clinically tested.Innovations for Phase II include a method for optimization of phase contrast optics for human sperm, the addition of strobed fluorescent capability to the internal optical system developed in Phase I, and rapid electronic alternation of strobed fluorescent and phase contrast illuminations. Computer software for this system will have the flexibility to produce data consistent with evolving WHO and CAP guidelines. The instrument will substantially increase both the range of tests accessible to automated semen analysis and the corresponding commercial opportunities for the end product.Awardee's statement of the potential commercial applications of the research:Clinical semen analysis, environmental reproductive risk assessment and automation of existing and future fluorescence-tagged reproductive assays offer expanding market opportunities estimated to be in excess of $150 million by 19 . In the U. S. and in Europe, the medical and environmental markets will consist of a total of 11,000 potential sales, which will include fertility clinics, IVF units, hospitals, universities, commercial laboratories, pharmaceutical companies and other major corporations.National Institute of Environmental Health Sciences (NIEHS)