Melody allows for proactive navigation of your breast health journey.

Melody Consists of Two Parts

Part 1

Tear collection which will occur at your provider’s office

STEP 01

A Schirmer strip is used to collect your tear sample. Your provider will fold the rounded end to make a “lip.”

STEP 02

Your provider will gently place the “lip” portion inside your lower eyelid and have you close your eye.

STEP 03

After the sample collection is finished, your provider will remove the Schirmer strip from your lower eyelid.

STEP 04

The Schirmer strip will be placed into the shipment tube and sent back to our facility at Namida Lab for testing.

Why Tears?

Blood

Certain large components in blood can make it difficult to see small cancer markers in the sample.

Tears

These large components aren’t present in tears, making small cancer markers much easier to spot.

Part 2

A Clinical Lab Test with a Melody Score and Classification returned to your provider

Melody Score and Classification

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.

Melody Scale

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.

Namida Lab is a high complexity CLIA-certified lab

FDA is responsible for developing the CLIA test complexity categorization rules and guidance.

What is CLIA?

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.

Melody is a screening test intended to be used to help women navigate their breast health journey

YOU NEED A SCREENING TEST WHEN

  • You’re not showing symptoms
  • You’re low risk for a disease

SCREENING TESTS USUALLY

  • Cost less
  • Really good at ruling in disease (High Sensitivity)

YOU NEED A DIAGNOSTIC TEST WHEN

  • You’re showing symptoms
  • You’re high risk for a disease

DIAGNOSTIC TESTS USUALLY

  • More expensive
  • Good at ruling out disease

69

Million women in the United States are within the recommended screening age of 40-74 years old

8,680

Total facilities offering mammography in the United States that are certified by the FDA through its Mammography Quality Standards Act (MQSA)

45

Women in the United States are not currently receiving an annual screening mammogram

Investigating the question: How does the use of Melody prior to mammography affect participation in breast health?

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.