On average 20% of couples find difficulties conceiving within the first year of trying. Statistically, in up to 50% cases male fertility issues may be at the source of the problem. Though, partially due to cost and partially due to social stigma associated with clinical evaluation or treatment, male infertility often stays undetected.
A recent study suggests that an average sperm concentration had fallen by 52% between 1973 and 2011, while another one concludes that men with low sperm concentrations could have an increased chance of morbidity and mortality. These results suggest an increasing importance of periodic semen characterization. This, in turn, accentuates the value of performing accurate cost-effective semen characterization in-home or at POC settings.
The fundamental evaluation of male fertility in the clinical laboratory begins with sperm characterization. Traditionally male sperm evaluation is performed in a laboratory through manually operated optical microscopy and/or with support of the automated CASA systems. However, despite efficiency of CASA systems, their buky size, high cost and maintenance needs partially hinder their widespread use in fertility clinics and are certainly not a realistic option for in-home use by consumers. At the same time, however, there currently does not exist a rapid simple-to-use inexpensive in-home platform capable of automated measurement of sperm count and sperm motility statistics.
Lucendi SPA is designed to mitigate shortcomings of the existing solutions by developing a unique platform bringing laboratory quality (quantitative) analytics to in-home, in-field and point of care (POC) applications. An initial prototype of Lucendi SPA platform has been recently developed and successfully evaluated in initial experimental trials. Lucendi is currently developing a second-generation prototype that is planned to be evaluated in 2019 by Lucendi’s partners in the US and in Europe, followed by an FDA regulatory process. In broader view, Lucendi SPA platform is a low-cost portable computational microscope. Furthermore, when coupled with Lucendi’s proprietary machine learning algorithms, it is also capable of automated classification of microscopic objects in a sample. Hence, the system can be generally applied for evaluation of not only sperm characteristics, but also of a variety of other targets, including cellular abnormalities.