STTR Phase I: A Urine Test for Kidney Cancer Detection

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve human health by early detection of kidney cancer to increase survival rates for kidney cancer patients. In 2023, kidney cancer impacted 81,800 Americans. Due to a lack of early detection methods for kidney cancer, most kidney tumors are found incidentally during diagnostic imaging for other purposes.

The proposed project will be the development of a novel, non-invasive kidney cancer screening test for use prior to imaging, to reduce unnecessary risk from imaging tests, to enable earlier cancer detection, and to serve as a preventive test for high-risk populations (age 50 to 75). A positive diagnosis through the proposed screening test will result in healthcare providers proceeding with confirmatory imaging tests for further analysis.

Using this test, malignant tumor cells in the kidneys and urinary tract will be detected in urine specimens, allowing for the initial detection of cancer and monitoring molecular residual disease (MRD). Due to the current lack of an effective biomarker or screening test for kidney cancer, there is significant commercial potential for the proposed test.

This Small Business Innovation Research (SBIR) Phase I Project seeks to develop a novel screening and surveillance test for kidney cancer from urine. Currently, there are no screening methods for kidney cancer aside from imaging modalities such as a computed tomography (CT) imaging. While non-invasive, use of routine imaging for kidney cancer screening is an impractical and costly approach for the general population.

The proposed project will have these objectives: 1) Demonstrate the specificity and accuracy of the biomarker for the detection of renal tumors from kidney cancer patients at early-stage disease without symptoms; 2) Demonstrate the effectiveness and accuracy of the test for detecting residual disease in kidney cancer patients of post-nephrectomy. If the proposed project is successful, the work will pave the way for developing and offering the test as a Laboratory Developed Test (LDT) service through a single validated clinical lab, and later pursuing FDA approval as an in vitro diagnostic device (IVD).

This noninvasive test will be easily accepted by a broad range of patients from different cultural backgrounds. As a result, this will help to increase the survival rate of kidney cancer patients who are diagnosed at an early stage without symptoms.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.