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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