CAMBRIDGE, Mass. -- A non-invasive test for bladder cancerdeveloped by Matritech Inc. will begin clinical trials within twoweeks.

Stephen Chubb, the Cambridge company's founder, presidentand CEO, made this announcement here Tuesday at aconference on "Technology Products in the '90s" that wassponsored by the Massachusetts Institute of Technology (MIT).

Chubb spoke on a panel called "Strategies for Accessing andCommercializing Government-Sponsored Research in a NewEra." He took Matritech's antibody-based assay for bladdertumors as a case in point. He noted that "MIT scientists werelooking at cells in a different way" in 1986, when theydiscovered nuclear matrix proteins, apparently unique topatients with bladder cancer. That research led to starting upthe company to commercialize the discovery.

The imminent diagnostic trial will take place at three hospitalsin Boston plus seven other medical centers throughout the U.S.,including facilities in Texas and Virginia. It will enroll 100post-therapy patients with bladder cancer to detect recurrenceof malignancy, Chubb told BioWorld. In addition, 300 to 500healthy people will be tested as controls. Chubb said he expectspivotal results within six to eight months, for submission toFDA.

Bladder cancer is diagnosed in 50,000 Americans a year and isfatal to 20 percent, Chubb said. After surgery -- usually bylaser ablation of the tumor -- 70 to 80 percent of patients haverecurrences within two years.

Early detection currently involves inspection of the bladder'sinterior by means of a cystoscope. This invasive procedure,Chubb noted, costs about $250. Matritech's urine test, whichtakes about four hours, will be priced at $20, he predicted.

Performed in a 96-well microtiter plate, it exposes the urinespecimen to a succession of two monoclonal antibodies thatrecognize the nuclear matrix protein. Unlike current tumor-associated antigens such as CEA (chorio-embryonic antigen)and alpha-fetoprotein, the bladder-related structural proteinsoccur inside the cell.

Matritech's marketing partner for the bladder diagnostic isHybritech, a division of Eli Lilly and Co.

-- David N. Leff Science Editor

(c) 1997 American Health Consultants. All rights reserved.