Studies Validate Clinical Utility of Cap-Score™ Sperm Function Test

MOUNTAINSIDE, N.J., April 18, 2017 /PRNewswire/ -- Androvia LifeSciences announced today the publication of two papers presenting clinical and technology validation studies in the journal Molecular Reproduction and Development, a Wiley publication. These data provide scientific evidence of the clinical utility and value of its breakthrough technology, the Cap-Score™ Sperm Function Test (Cap-Score SFT). A laboratory developed test, the Cap-Score SFT is the only test that can determine if sperm can capacitate, indicating the percentage of sperm that can actually fertilize an egg, and comparing each man's results to a normal, fertile population.

"The Cap-Score Sperm Function Test represents a new frontier in semen analysis and allows us to personalize treatment for couples from the very beginning," said Dr. Fady Sharara, one of the leading fertility specialists in the country and one of the first to offer the test, at his practice the Virginia Center for Reproductive Medicine. 

These new publications establish and demonstrate the clinical utility, efficacy and significance of the Cap-Score SFT.  The first paper presents the results of two separate clinical studies, one conducted at Cornell University's world leading fertility clinic, the other at Androvia's research lab.  In a trial of men with long histories of unexplained infertility, men with high Cap-Scores above a certain threshold, had a 92% chance of conceiving by natural conception or within three cycles of intrauterine insemination.  Conversely, men with Cap-Scores below that threshold had only a 21% chance.  In the second trial, the Cap-Scores from a group of 76 men with proven fertility were compared against those of 122 men seeking semen analysis because of difficulty conceiving.  A significantly higher percentage of men questioning their fertility (34%) had abnormally low Cap-Scores, compared with only 13% of the fertile men.

These data demonstrate that the Cap-Score strongly reflects fertility, and can provide value as a general screening test for men questioning their fertility. Physicians can now guide couples toward the most appropriate form of assisted reproduction from the start of therapy.

The second paper validated the underlying technology, demonstrating the accuracy, reproducibility and precision of the test.  The Cap-Score is based on the fact that G_M1, a lipid on the sperm surface, is found in different regions of the head of a capacitated sperm versus one that can't fertilize.  Several experimental methods were used to confirm the relationship between these patterns of G_M1 localization and the capacitation status of single sperm.  Next, over 100,000 sperm images were used to determine the reproducibility and repeatability of the Cap-Score when read by trained analysts.   Finally, experiments to study the impact of semen handling methods on sperm function demonstrated that chymotrypsin and bromelain, two commonly used agents to facilitate semen analysis and handling had a deleterious effect on sperm function.

Cap-Score reflects sperm fertilizing ability and it provides highly accurate, reproducible, and reliable results.  It helps diagnose the fertility status of individual men, and can be used to assess the impacts of laboratory methods used around the world to improve how assisted reproduction is performed.

The Cap-Score SFT provides a new and promising complement to traditional semen analysis to evaluate male fertility.  Previously, the scores provided by semen analysis gave only descriptive information on how many sperm there are, how well they swim, and how they look.  They failed to identify the majority of men with fertility problems because they provided no information on sperm function—the ability of sperm to actually fertilize an egg.

"More accurate testing is the first step towards more effective treatments. The Cap-Score Sperm Function Test can prove to be a game changer for physicians who treat infertility and for their patients," said Dr. Eric Seaman, one of the leading practitioners of male reproductive medicine in New Jersey and whose practice, Urology New Jersey, is the largest urology practice in the state.

"The Cap-Score Sperm Function Test will have an immediate impact on the millions of cases of unexplained infertility with a particular emphasis on men," said Michael V. Novinski, CEO of Androvia LifeSciences.

To read these studies in their entirety, please visit the following:

• Localization patterns of the ganglioside G_M1 in human sperm are indicative of male fertility and independent of traditional semen measures (DOI: 10.1002/mrd.22803) http://onlinelibrary.wiley.com/doi/10.1002/mrd.22803/full
• Validation of a laboratory developed test of human sperm capacitation (DOI: 10.1002/mrd.22801) http://onlinelibrary.wiley.com/doi/10.1002/mrd.22801/full

Infertility
Approximately 73 million couples experience infertility globally. At least 6.7 million infertile couples live in the United States. Male factor infertility contributes to roughly half of all cases of infertility, and 50% of male infertility cases are unexplained by traditional semen analysis.

About Androvia LifeSciences
Located in Mountainside, NJ, Androvia LifeSciences is a CLIA registered laboratory. The company's first product, the Cap-Score SFT, has been developed to empower couples and clinicians with critical information, helping them to achieve more personalized fertility solutions.  For more information on Androvia and the Cap-Score SFT please visit www.androvialifesciences.com.

SOURCE Androvia LifeSciences

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