By Debbie Strickland

Matritech Inc. has submitted a 510(k) premarket notification to the FDA for clearance of a second test for cancer based on the company's nuclear matrix protein (NMP) technology, which correlates levels of NMPs in body fluids to the presence of cancer.

Tested in 1,000 clinical trial samples, the NuMA (nuclear mitotic apparatus) Test Kit is a blood test that detects a nuclear matrix protein present at elevated levels in colon cancer cells.

Matritech last year launched an NMP22 Test Kit for those at risk for recurrence of bladder cancer. Also based on nuclear matrix protein detection, the urine test sells for $50. Matritech recorded $317,000 from product sales, including research-use-only products, during the first half of 1997.

As of June 30, the company had cash and cash equivalents totaling $14.8 million, following a first-half net loss of $3.6 million.

News of the NuMA Test Kit regulatory filing lifted the Newton, Mass., company's shares (NASDAQ:NMPS) to $7.188, a gain of $0.563.

Matritech's NMP technology was developed by scientists at the Massachusetts Institute of Technology, in Cambridge, in the early 1980s and was later licensed exclusively by the company, founded in 1987.

"The stunning finding that the MIT scientists made," said Stephen Chubb, CEO of Matritech, "was that when a cell of a [specific] type becomes malignant, there's a reliable and predictable change in its nuclear matrix proteins. We use the proteins that are present in the malignant form as targets for our tests."

Test May Have Broader Applications

If the NuMA test clears the FDA, it will be used initially to monitor and manage patients already diagnosed with colon cancer.

"We believe the test also has utility in identifying patients with high-risk polyps," said Chubb, "but that's the subject of a clinical trial that we intend to submit in 1998."

He expects the test to be reimbursed at a rate of between $30 and $40 per test, with Matritech receiving per-test revenue of $10 to $20.

The market for recurrent colon cancer diagnostics currently is dominated by the carcino-embryonic antigen (CEA) test, whose worldwide sales exceed $100 million. According to Matritech, the CEA test's "sensitivity is less than 50 percent and it is not useful for the 25 percent of colon cancer patients who do not exhibit elevated levels of the CEA antigen."

In a trial comparing the NuMa Test Kit to the CEA test, NuMA exhibited greater sensitivity in pre-surgery patients with intermediate-stage colon cancers.

The company did not release numerical clinical data for its test.

"We're extremely sensitive about pre-selling the test," said Chubb. "We don't want to be in a position where we appear to be pre-selling the test prior to the FDA's making its decision or taking its action."

He did say that clinical results were comparable to those observed in preclinical tests in which an NMP-based prototype assay identified 71 percent of patients with early-stage colon cancer, while the CEA test picked up only 33 percent.

Matritech also is developing NMP-based cervical and breast cancer tests.

Partnered with Bayer A.G., of Leverkusen, Germany, the cervical cancer project has hit four of five milestones, and Matritech is on track to reach the fifth "in the near future," said Chubb. Bayer, whose U.S. headquarters is in Pittsburgh, has rights to an automated version of the test, while Matritech retains the right to develop a manual test (one that is evaluated visually by the human eye).

The earlier-stage breast cancer project has a European partner, and could reach clinical trials next year, along with Matritech's manual cervical cancer test. *

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