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Background

There are more than 500,000 cases of bladder cancer in the U.S., and more than 70,000 new cases are diagnosed each year. Bladder cancer has the highest recurrence rate of all cancers. As a result, a large percentage of patients have lifelong, frequent and costly follow-up procedures (cystoscopy and biopsy) to test for tumor recurrence and progression. This lifelong follow-up makes bladder cancer the most costly cancer on a per-patient basis. Most patients (70%) present with superficial tumors and their cancer can be effectively treated. Superficial tumors (Ta/T1) are primarily managed through bladder-sparing approaches using cystoscopy, TURB-T (trans-urethral resection of bladder tumor) and intravesicular treatment (i.e., BCG). With muscle-invasive tumors (T2 and above), cystectomy is the primary management strategy.

Patient management decisions are heavily dependent on accurate clinical staging and grading of the biopsy or TURB-T specimens. Unfortunately, studies have shown that clinical staging often under-stages a bladder tumor compared with the pathological staging and grading done after cystectomy. For example, up to 40% of tumors presumed to be T1 (non-muscle invasive) are shown to be muscle-invasive when post-cystectomy pathological staging is done shortly thereafter.

Bladder Cancer Aggressiveness Test

Because accurate staging has important implications for correctly assessing the aggressiveness of a tumor and for patient management decisions, Metabolon is developing a tissue-based test to assess bladder tumor aggressiveness through a biochemical staging of tumor specimens. This test will detect metabolic signatures associated with tumors known to be aggressive (T2) by post-cystectomy pathological staging in TURB-T/biopsy specimens. This information will give clinicians an increased level of confidence when making patient management decisions (i.e., pursue a bladder-sparing active surveillance strategy or opting for a more aggressive strategy involving cystectomy).

Bladder Cancer Detection Test

Diagnosing the recurrence of bladder cancer relies on frequent, invasive and costly cystoscopic visualization of bladder tumors and the use of some adjunct biomarkers (i.e., cytology, FISH) to help in certain, mostly high-grade, cases. Metabolon is developing a non-invasive urine-based test to detect metabolites associated with bladder tumors with high specificity, regardless of the stage and grade of the cancer. This test will be used to guide patient-management decisions during active surveillance, and may be used as a gating test to initial or follow-up cystoscopies and other invasive procedures.

Bladder Cancer Occult Metastasis Detection Test

After bladder cancer is diagnosed and patients are treated by TURB-T or cystectomy, physicians check for signs of local and metastatic recurrence at regular intervals. 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. Metabolon is developing a test to 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 each patient.