Renal Cell Carcinoma

Background

Renal cell carcinoma (RCC) is the most common form of kidney cancer. The rate of new RCC diagnoses is rising by 2% a year, which is a far faster rate than any other cancer. In the U.S., 275,000 patients are screened for kidney cancer every year, and 55,000 are diagnosed with RCC. Most kidney tumors are detected as “incidental findings” from imaging tests like MRI or CT scans that are performed for reasons other than checking the kidneys. The majority of tumors(70%) are detected in early stages when the tumor is small. It can be difficult for physicians to tell which of these small renal masses are malignant, and which are benign. This uncertainty results in unnecessary surgeries and biopsies in order to definitively diagnose the presence of cancer. When RCC is diagnosed, the treatment is surgical removal of all or part of the affected kidney. In the early stages where RCC has not spread beyond the kidney, surgery is performed with curative intent. However, 20-40% of early-stage patients who do not have detectable metastasis at the time their kidney is removed later develop metastatic disease. There is no cure for metastatic RCC, and therefore better tests to diagnose the presence of RCC as well as the likelihood that a given tumor will metastasize will enable better clinical management of the disease.

Renal Cell Carcinoma Detection Test

Metabolon is developing a test to detect the presence of RCC by measuring a panel of metabolite biomarkers in blood or urine. This diagnostic test will accurately distinguish which small renal masses are RCC, and which are benign. This information will allow physicians to determine whether the patient requires confirmative biopsy or surgery, or whether they can avoid these procedures and be placed on a program of active surveillance.

Renal Cell Carcinoma Recurrence Risk Test

Metabolon also is developing a test to measure specific metabolites extracted from a small amount of tumor tissue removed during a biopsy or nephrectomy. By detecting this metabolic signature that is similar to more advanced, metastatic tumors (T3-T4), the test will identify which early-stage tumors (T1-T2) that are presumed to be low/intermediate risk are actually more aggressive. This test result will give clinicians additional information beyond traditional pathological staging to inform their treatment decisions for patients with early-stage RCC.

Renal Cell Carcinoma Occult Metastasis Detection Test

After RCC is detected and patients are treated by surgery (full or partial nephrectomy), physicians provide follow-up care at regular intervals to check for signs of disease recurrence (metastatic disease). Very small metastatic lesions, known as micro-metastases, are usually asymptomatic and may not be detectable on imaging tests such as a CT scan or MRI until they reach a larger size. If these micro-metastases are detected earlier, physicians can treat the patient sooner and more effectively. Metabolon is developing a test that will detect the presence of hidden and asymptomatic metastases based on a panel of metabolites in blood or urine. This test is intended for use in the treatment follow-up setting, either along with standard imaging tests or as a gate to imaging tests. Identifying metastatic disease earlier gives clinicians additional information to choose the most appropriate therapy for their patient.