STEP 01
A Schirmer strip is used to collect your tear sample. Your provider will fold the rounded end to make a “lip.”
A Schirmer strip is used to collect your tear sample. Your provider will fold the rounded end to make a “lip.”
Your provider will gently place the “lip” portion inside your lower eyelid and have you close your eye.
After the sample collection is finished, your provider will remove the Schirmer strip from your lower eyelid.
The Schirmer strip will be placed into the shipment tube and sent back to our facility at Namida Lab for testing.
Certain large components in blood can make it difficult to see small cancer markers in the sample.
These large components aren’t present in tears, making small cancer markers much easier to spot.
If your Melody score is below 0.1 your classification will be Low
Talk to your healthcare provider about your health result. Your provider can make a recommendation on a screening schedule that is best for you.
False negatives do occur.
A false negative result occurs when you receive a Melody classification of Low even though a screening mammogram indicates an area of concern.
If the Melody score is above 0.1 the classification will be High
Any High classification should be discussed with your healthcare provider and followed up with a screening mammogram.
False positives do occur.
A false positive result occurs when you receive a Melody classification of High even though a screening mammogram finds no area of concern.
The Melody Scale is intended to be a tool for facilitating conversation with your provider to determine next steps in your breast health journey. The scale was developed from the scores of over 700 women enrolled in our clinical trial.
FDA is responsible for developing the CLIA test complexity categorization rules and guidance.
CLIA (Clinical Laboratory Improvements Amendment) is a program overseen by CMS (Centers for Medicare and Medicaid services) which was established to provide quality standards, strengthen federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test results.
The VIOLA Study: Validating Individualized breast cancer screening by Offering a new Link in Access
A study with large employers and federally qualified health centers to reach populations of women who are overlooked by the current screening options.