Development Stage: The test is currently optioned to one of the largest clinical laboratory networks in the world for the North American market.

Project information:

Azoospermia is a condition of male infertility where no normal sperm is found in the semen, which may result from obstruction or testis failure (non-obstructive). Currently, the only way now to definitively make the diagnosis is with a testicular biopsy. 

Instead, two Doctors from Canada instituation are developing a non-invasive, ELISA test based on three protein biomarkers from semen to distinguish between the two forms of azoospermia with high sensitivity (>90 per cent sensitivity) and specificity (>95 per cent). 

This test will provide essential information to plan the surgical procedures to repair the obstruction or to attempt to retrieve small numbers of sperm from the testis (for non-obstructive azoospermia). The inventors are also exploring the utility of these same markers for post-vasectomy confirmation testing; the vasectomy procedure is essentially simulated obstructive azoospermia. 

The test is currently optioned to one of the largest clinical laboratory networks in the world for the North American market but is available for the Japan, the European Union and ROW.