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VOLUME MICROPROBE TM ASSISTED BLADDER BIOPSY

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: CA71224-01A1
Agency Tracking Number: 39330
Amount: $76,077.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 1997
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
100 INMAN ST, STE 2
Cambridge, MA 02139
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 MODELL, MARK D
 () -
Business Contact
Phone: (617) 661-4300
Research Institution
N/A
Abstract

Approximately 40,000 new cases of early stage transitional cell carcinoma (TCCA) present annually in the US. Over 30,000 are superficial; 75% recur; 10-15% progress to invasion. Surveillance cystoscopies are required over the patient's lifetime (about 600,000 cystoscopies annually). Early stage flat TCCA is frequently occult, routinely requiring 6 random biopsies of physician-selected sites. The MediSpectra cystoscopic spectrophotometer (CystoProbe) will examine these sites and differentiate neoplastic from non-neoplastic urothelium, and eventually, provide objective aid for staging and grading. Its use will result in earlier identification of occult TCCA, lowering progression to invasion and might half the biopsies per cystoscopy. Annual medical care costs would be reduced by about 31 million. If fewer biopsies per cystoscopy permit more cystoscopy under topical anesthesia in an office setting, annual saving could amount to >$500 million. The major medical benefits: decreased lagtime between appearance of abnormal urine cytology and the diagnosis and treatment of recurrent TCCA with possible positive impact on disease-free survival. We will fabricate a CystoProbe, perform measurements on 30 patients with previous diagnosis of bladder TCCA, and analyze the results to determine how well the CystoProbe can differentiate malignant from non-malignant urothelium and if it can do this significantly better than the urologist's eye.

* Information listed above is at the time of submission. *

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