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Research Project: Affordable Lateral FLow urine test for Ovarian cancer risk

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Ovarian Lab Project seeks to create affordable and accessible tests for ovarian cancer recurrence risk. Our test will allow women to detect the first symptoms of recurrence before survival outcomes drop. 

Women with health insurance who are diagnosed with Ovarian Cancer on average spend $3,000 out of pocket on the disease each year. After completing treatment, 70% of cases the disease will return. For many women in resource limited environments, monitoring the disease is cost prohibitive. The FDA approved blood test to monitor reoccurrence of HE4 is a $650. A women still needs to take off work, and come into a doctor's office to do this blood test. 

It's safe to say women could be monitoring their levels in a less invasive and cost effective way that suits her schedule.  

Many cancers are detected with a blood test by using biomarkers. However, for someone to schedule this blood test, usually other symptoms are accompanied to warrant the testing. However, ovarian cancer often presents with ambiguous symptoms such as cramping, frequent urination and irregular bleeding. These symptoms are already present in the general population at equal frequency, so they are not good indicators of the disease. In fact, ovarian cancer can present with no symptoms at all especially in the early stages. Additionally, the typical CA-125 blood test misses 50% of early ovarian cancer cases.

Urine contains HE4 biomarker targets as well but are currently not used in the marketplace. Additionally, there have been studies in healthy young women, to quantify the expression of HE4 vs CA125 during the follicular, ovulatory, and luteal phases of the menstrual cycle and the possible correlation with age. More research is needed to define a threshold for normal expression for He4 in every age group.

The current FDA cleared Ovarian Cancer risk tests, are $650 per test with blood taken from the arm. Our goal is to design a simple LFA test for a HE4 biomarker. This would allow women presenting symptoms, to afford to assess their risk of malignancy.

Impact

Despite the advances in medicine and diagnostics, ovarian cancer ranks as the fifth leading cause of cancer deaths in females. Worldwide, this figure is over 125,000 deaths per year. Ovarian cancer kills more women than any other type of reproductive system cancer. Ovarian cancer is also the 2nd most expensive cancer to treat behind brain cancer.

To date, only 60 percent of women are even familiar with the signs and symptoms of ovarian cancer. Since the symptoms (bloating, cramping, and frequent urination) are not specific to ovarian cancer, many cases are missed, and progression of ovarian cancer is too expensive to monitor for low income women.

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Figure 1. Table shows Ovarian Cancer stage statistics from Zhang, Z. (2012).

Since early detection provides the best outcome for survival, making the test easier and using localized human material (urine or menstrual blood) could provide a much earlier method for earlier detection of ovarian cancer progression for women presenting symptoms. Since HE4 is quite a small protein biomarker for ovarian cancer, and it goes through the kidneys into urine, one could easily sample urine for the analysis but there is yet to be a diagnostic test for it. In fact, in 2013, a Harvard team used an ELISA western blot to detect HE4 in urine successfully. However, ELISA is an intensive test requiring many technical steps for several hours or even days by a trained lab worker.

One 2012 study population consisted of 180 women, including 126 endometriosis patients and 54 healthy women. They measured their serum HE4 and CA125 concentrations and evaluated the effect of the menstrual cycle and the possible hormonal medication on these marker concentrations. They found no significant variation in serum HE4 concentrations in samples taken at different phases of the menstrual cycle. The median HE4 concentrations in proliferative, secretory and menstrual phase were 41.5, 45.1 and 35.3 pM in healthy women, and 43.4, 44.3 and 43.0 pM in endometriosis patients, respectively. The use of combined estrogen and progestin contraceptives did not affect serum HE4 levels significantly. The study shows that the HE4 measurement in healthy premenopausal women as well as in women with endometriosis can be carried out at any phase of the menstrual cycle, and irrespective of hormonal medication, extending the benefits of HE4 use in clinical practice.

In a 2017 study reported that serum human epididymis protein 4 levels are relatively stable across the menstrual cycle of reproductive-aged women and can be determined on any day to evaluate risk of ovarian malignancy.