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A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.

Schirmer Strip

Suzanne Klimberg, MD, PhD

This study aims to collect tear samples from 50 women who have been recently diagnosed with breast cancer.

Namida Lab, Inc. is a biotechnology company located in Fayetteville, AR, with a certified, high-complexity CLIA lab. In January of 2021, Namida Lab, Inc. completed the analytical and clinical validation of a tear-based biological screening test for breast cancer based on proteins from tears. The validation process was carried out manually and now needs to be conducted on the Hamilton StarPlus automated ELISA system. To complete the robot validation, Namida Lab, Inc. needs fifty (50) tear samples collected from women recently diagnosed with breast cancer but who have not undergone any treatment.

Tear Based Sample Collection Breast Cancer Detection

Tear Based Sample Collection for Breast Cancer Detection

IPD will not be shared or made available to other researchers.

The purpose of this study is to collect 50 tear samples from women who have been recently diagnosed with breast cancer.

The University of Texas Medical Branch, Galveston

Namida Lab

Women mammographically categorized as having either heterogeneously dense or extremely dense breast tissue.

A tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA-certified lab. It consists of two parts: tear sample collection using a Schirmer Strip and a clinical lab-developed test that measures protein biomarkers for breast cancer screening.

Anna Daily, PhD

Prashanth Ravishankar, PhD

Investigation of a tear-based, lab-developed biological test for breast cancer, as a supplemental tool to current screening recommendations for women with dense breast tissue will explore if a tear-based biological test can be used as a support tool in the breast cancer screening protocol for women with dense breast tissue. The test was designed and validated by Namida Lab, Inc., a high complexity Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Eligibility is based on individuals who biologically qualify to participate in yearly breast cancer screening and who have dense breast tissue.

A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue

Investigation of a Tear-based, Lab-developed Biological Test for Breast Cancer, as a Supplemental Tool to Current Screening Recommendations for Women With Dense Breast Tissue.

Individual participant data is not intended to be shared with other researchers at this time.

Degree of closeness of categorization by a tear-based biological test scores to imaging techniques

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
Tear Based Sample Collection Breast Cancer Detection	NCT04974567	Breast Cancer Tear Breast Cancer F...	Schirmer Strip	18 Years - 100 Years	Namida Lab
A Tear-based, Lab-developed Test for Breast Cancer for Women With Dense Breast Tissue	NCT05268224	Breast Cancer S...	Schirmer Strip	18 Years - 100 Years	Namida Lab

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