Namida Lab will conduct a clinical study to assess the performance of a tear-based breast cancer screening test, Melody, for women with dense breast tissue.
Melody is a simple, accurate, inexpensive and convenient screening test for breast cancer that uses proteins from tears.
It has been developed as a supplemental tool to existing screening recommendations.
According to the company, dense breast tissue is detected in roughly 50% of mammograms. While these images can help to measure the amount of glandular and connective tissue compared to fatty tissue, other clinically relevant findings, including tumours, can be obscured by dense breast tissue.
The clinical study will be conducted at The University of Texas MD Anderson Cancer Center. It will begin this month and continue for six months.
Approximately 100 women will be enrolled in the tear collection study, which will be fully funded by Namida Lab.
Namida Lab product development and innovation vice-president Anna Daily said: “This study will lead to incredible outcomes to implement Melody as a part of the current screening process for women with dense breast tissue, since the results of Melody are not limited by tissue type, and therefore a promising avenue in detecting breast abnormalities.”
The company stated that women who have previously been identified as having dense breast tissue and are booked to have a mammogram will be offered the chance to enrol in the study.
The subjects’ tear samples will be collected by placing a strip of filter paper in the lower eyelid for about five minutes. This strip will be sent to Namida Lab to be assessed for breast cancer markers.