The work to develop Melody began with establishing clinical partnerships for the collection of tear samples, as a repository for tear samples does not exist. These collaborations enabled not only acquisition of samples but also experimentation on the optimization of tear collection as well. The tear proteome was characterized utilizing standard biochemical techniques and traditional statistical analysis to identify potential biomarkers of disease. This work was carried out by Fayetteville based start-up, Ascendant Dx.
The robustness of protein biomarkers identified through the discovery work was confirmed through acquisition and analysis of over 1200 samples. Through this work, Melody began to come to life. The successful validation of our tear-based assay, and subsequent patent coverage, prompted the acquisition of Ascendant Dx, licensing of the IP, and transfer of the entire development team to Namida Lab, Inc.
Translation of research and development to a product is a pivotal make or break milestone for a biotech company. With the technology and development team now residing at Namida Lab, designing a validation protocol for the development of Melody as a Lab Developed Test (LDT) began in earnest. In January 2021 after nearly a decade of work, the validation of Melody as a lab developed test was completed.
Optimization of Melody is a daily pursuit and will become even more relevant to the ecosystem as we gather input from providers and patients through execution of the VIOLA study. Our vision for tear testing extends far beyond breast cancer screening. From diagnostics to treatment monitoring as well as applications to different types of cancers, we’ve only just scratched the surface on the utility of tear testing.