Celebrate progress: New cancer screening tool in works
Director of Clinical and Regulatory Affairs, Anna Daily, for the Arkansas Democrat-Gazette:
Today, we mark the beginning of Breast Cancer Awareness Month, when we recognize the women and men whose lives have been upended by this diagnosis. It's also a time to celebrate progress and look toward the future.
One in eight women will be diagnosed with breast cancer. It's a sobering reality--and one that affects nearly everyone, including me. My grandmother is a breast cancer survivor; she is one of the reasons I've dedicated my professional career to innovation in breast cancer screening.
I received my Ph.D. from the University of Arkansas in cell and molecular biology. My post-doctoral work focused on protein biochemistry, which is what led me to the tear project, something I've been working on for almost a decade.
Currently, I am the director of Clinical and Regulatory Affairs at Namida Lab--headquartered in Northwest Arkansas--and am working on the most exciting and promising project of my career. We are currently in clinical trials for a tear test we call "Melody®."
Our primary goal for Melody® is to introduce it as a "pre-screening" test that is supplemental to mammography. This test is done by placing a small strip of filter paper inside the lower eyelid to collect the tear proteins. In the lab, we determine how much protein is in a patient's tears and use that number--along with a few pieces of clinical information--to determine if your proteins are at a level which suggest you are at an increased need for imaging tests.
Our hope is that this test can be used as an education and encouragement tool for women who do not utilize mammography for various reasons.
The tear test's primary benefit is that the sample is easily collected at any clinic, making it accessible to places where imaging equipment may not be located. Although legislation has been passed and projects funded to increase the access to mammograms, the reality is there are still women in our state, and around the world, for whom the proper equipment and technicians simply aren't available. For some patients in Arkansas, the closest mammogram screening can be up to 200 miles away.
To date, we have conducted five rounds of testing with more than 1,200 women, the majority of whom were from enrolled clinics in Arkansas. We are so grateful to the women who have participated and the medical professionals who have supported us and referred patients to our study, and we are extremely optimistic about what we are seeing in the trials.
Our next step is to validate the test in our high complexity Clinical Laboratory Improvement Amendment (CLIA) lab, which is overseen by the Centers for Medicare and Medicaid Services. This is currently underway, and we hope to have this process completed by the end of 2020.
Although we are primarily focusing on breast cancer, we are also looking into isolating proteins for other types of cancers and diseases.
Melody®, and tear testing, has the potential to empower individuals to take control of their health, and it's happening right here in Arkansas. We are so fortunate to live in a state that encourages medical innovation. As a native Arkansan, I am so proud of this work. My colleagues and I are working around the clock to bring better, easier, more accessible diagnostics in the fight against breast cancer.
As we look to a month filled with breast cancer awareness, I want to stress the continued importance of mammography. It is currently the best tool we have in this fight. Although covid-19 has affected everything, I encourage you to honor your annual screenings or to schedule the appointment you may have been putting off. Early detection is key.
If you are interested in our progress, please follow us on social media at @namidalabs on Facebook, @NamidaLab on Twitter, or @namidalab on Instagram. And look for more information about Melody® at your next doctor's appointment.
Finally, I encourage everyone to take some action this month. Make a donation, volunteer, honor those we've lost, encourage those who are undergoing treatment, and celebrate the survivors.
Anna Daily, Ph.D., is the director of Clinical and Regulatory Affairs at Namida Lab where she works to establish clinical, industrial, and academic partnerships both locally and across the country. Anna is also a co-inventor of Melody®, Namida's novel tear-based breast cancer screening test.
