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Company Reports Initial Success with Breast Cancer Blood Test

 

By Doug Macron

NEW YORK, Jun 02 (Reuters Health) - Matritech, Inc., of Newton, Massachusetts, announced on Thursday (6/1/00) that it has completed the proof of clinical concept for its NMP66 breast cancer blood test.

The test, said Matritech, is based on its nuclear matrix protein (NMP) technology, which correlates the levels of nuclear matrix proteins in the body to the presence of cancer.

According to the company, the trial consisted of 78 specimens tested using proprietary specimen preparation and mass spectrometry procedures.  Forty-five of the specimens were taken from women diagnosed with breast cancer in various stages, while five were taken from women with Ductal Carcinoma in Situ (DCIS).  The last 28 specimens came from women who were either normal or diagnosed with benign disease.

"We detected every case of cancer, and ruled out cancer for all normal samples," David L. Corbet, president and COO of Matritech, said.  "Based on this...we consider 'proof of concept' complete."

However, due to the small number of specimens, which came from patients that the company knew did or did not have cancer ahead of time, Dr. Clifford Hudis, chief of breast cancer medicine services at Memorial Sloan-Kettering Cancer Center, expressed concerns that the test may not be accurate with larger patent populations.

"If [the test] has even a low rate of false-positive results...[and you test] a million people...then you have thousands, literally, of positive results that don't indicate cancer," he said in an interview with Reuters Health on Thursday.

Since the 78 specimens of the trial are the entire scope of Matritech's testing of NMP66 so far, "the company will be engaging in a much larger clinical trial, perhaps by the end of the year," a Matritech spokesman told Reuters Health.  "Should the results and the data prove encouraging, [the company] may be in a position at that point to either broaden the trial or go right to the [US Food and Drug Administration]."

"The company is not looking to replace mammography," he added.

Citing difficulties sometimes encountered when performing mammography on younger women, as well as errors that can occur with the interpretation of mammograms, the spokesman said that Matritech believes that the NMP66 test may be used to complement the standard breast cancer screening procedure.

Dr. Hudis said that, in the setting of an abnormal mammogram, a test such as NMP66 could be very useful.

The test is covered by three patents issued to the Massachusetts Institute of Technology, which are exclusively licensed to the company.  Matritech said that it has filed an additional four patents that seek coverage for the use of NMPs in the management of breast cancer.



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