Photo demonstrates tear sample collection with a Schirmer strip for testing of biomarkers associated ... [+]
The methods for detecting breast cancer have not developed much during the last century. The currently most common way of screening for breast cancer is mammography and was performed for the first time already in 1913 by the German surgeon Albert Solomon. Despite mammography's long history, most parts of the world still use palpation (breast examination) as the primary screening tool, with the risk of detecting the cancers at a later stage. If detected early, survival rates of breast cancer is close to 100% — but it can decrease to under 70% for some types of stage III cancers.
In the mid-2000s, Dr. Suszanne Klimberg, currently Chief of Surgical Oncology at the University of Texas Medical Branch, noticed that many of her patients from rural areas came in with late-stage breast cancer. It turned out that they have had no access to breast screening, where they lived. This motivated Dr. Klimberg to search for a simple screening method to be used at primary care level to detect the disease at an early stage, and this is how the idea of development of an easily deployed lab test to screen for breast cancer was born.
The method that Namida Lab has developed uses biomarkers in tears which are specific for breast cancer. Omid Moghadam, founder and CEO of Namida, told me that tears are an ideal medium for lab testing. Tears are a highly concentrated biological fluid, and you can access them non-invasively. They contain most of the biomarkers that can be found in blood.
Examples of such biomarkers are proteins, DNA, cell plasma, hormones, and glucose. Furthermore, tears are a very clean fluid which makes it easier to detect signals from the biomarkers. The biomarkers used to detect breast cancer are proteins which can also be found in blood, but as the signal in blood is less clean it requires more preparatory work to extract it, which makes the blood tests more expensive.
A special strip is used to collect the tears. It is a specialized filter paper strip that is placed in the lower eyelid to absorb the liquid. It is commonly used to measure the quantity of tear liquid during Schirmer’s test. The collection procedure takes only 3-5 minutes, and the test strip is then sent to Namida’s lab for analysis. In the lab they are checking the presence of the specific proteins that are significant for breast cancer.
According to Moghadam, the sensitivity of the test is 92%, and the specificity 58.4%. This means that if you have cancer, the test is 92% likely to detect it, but the low specificity means that there is a high rate of false positive results. Therefore, if you get a clinically significant test result, there is a high possibility that it might not be correct, or your cancer is still too early to be detected by a mammogram. Despite all, this is still a good screening test because it selects which patients should get a more thorough examination. The patient will receive a rating of high, medium, or low risk of developing breast cancer and a recommendation of the next steps.
The Namida test can be performed at home, which is important since half of all women do not attend their mammogram screening. Furthermore, mammography is not working well for women with dense breasts, which is more common in Hispanic, Asian and black women, so this is a group of women for which this test could be very helpful. Another group that would benefit from this test are women under 40, who currently are not offered standard screening with mammography. Breast cancer in this age group has been increasing over the last years and women under 45 now account for about 10% of all breast cancers and half of all mortality in breast cancer.
Namida is not the only company that is using tears to screen for breast cancers. A Japanese team of researchers from the Kobe University has developed a similar solution. Many other companies are focusing on genetic testing as the presence of a mutation in the BRCA1 and BRCA2 genes are predictive of breast cancer. However, it is costly to trace these mutations, and they are accountable for less than 10% of all breast cancers, which is why it is important to have methods to find all the other cases.
Namida Lab’s test has been available on the market for about a year and is sold over the counter under the brand name Auria. The company is backed by venture capital and is currently fundraising.
"Namida’s mission is to develop innovative cancer screening tests that are inexpensive and accessible in order to increase early-stage cancer detection, reduce cancer spend, and improve health outcomes for all," said Moghadam.
