Nearly 10 years of development paid off Monday for Matritech Inc.with FDA approval of its product for testing those at risk forrecurrence of bladder cancer.

The Matritech NMP22 Test Kit, a urine-based assay, is the firstproduct approved based on nuclear matrix proteins (NMP), atechnology involving use of antibodies to detect cancer-specificNMPs. The technology is based on the finding that NMPs in cancercells differ from those in normal cells.

Matritech's stock (NASDAQ:NMPS) gained 88 cents Monday toclose at $11.13. The company is under registration for a two millionshare offering. (See BioWorld Today, June 19, 1996, p. 3.)

"We consider this the most important [diagnostic] approval in 10years," since the prostate specific antigen, Matritech CEO StephenChubb said. He said other products approved recently haven'tamounted to much clinically.

NMP22 is used after surgery for bladder cancer. A low NMP value10 days after surgery indicates near-90 percent certainty that a patientwill not have malignancy at three months, said clinical investigatorDaniel Rukstalis, chief of urology at Medical College ofPennsylvania. Elevated NMP at 10 days means it is likely recurrencewill be detected at three months, he said.

The product could reduce the number of cystoscopies performed,thereby reducing costs and discomfort for the patient. Invasivecystoscopy cost about $300; the NMP test will cost about $50. About500,000 people in the U.S. are monitored regularly for recurrence ofbladder cancer, the company said.

Matritech, of Newton, Mass., has a marketing and product-purchaseagreement for NMP22 with UroCor Inc., of Oklahoma City, whichfocuses on the urology market. Matritech will sell the product toUroCor, which has the largest urology reference laboratory in thecountry and 30 salespeople. Matritech also will use its own three-person sales force.

"This is the first in a series of nuclear matrix protein-based tests thatshould dominate cancer testing in the future," Chubb said. "We're ontrack to develop additional tests that are more accurate than existingtechnologies."

Matritech intends to start clinical trials of an NMP-based coloncancer product this year, Chubb said, and has plans for additionaltests for prostate, cervical and breast cancers. The cervical cancer testis being developed in collaboration with Bayer Corp.'s diagnosticdivision in Pittsburgh.

Matritech in 1987 licensed rights to the technology from theMassachusetts Institute of Technology. Matritech developed thetechnology for a few years before starting on the bladder cancerindication in 1991. n

-- Jim Shrine

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