Scientists at Matritech, Inc. have just completed a preliminary study of a new blood test that may help detect breast cancer . The study tested the blood of 78 women for the nuclear matrix protein (NMP), a protein that is thought to be present in elevated amounts in patients with cancer. The test correctly identified cancer in all but one of the women in the study. Though larger clinical trials are still needed, the researchers are optimistic that the NMP test may eventually become useful in conjunction with mammography to help screen for breast cancer in women who do not show any signs or symptoms of the disease (such as a breast lump, thickening, etc.).
The breast cancer blood screening test, dubbed NMP66 by Matritech, produced the following results:
- Detected 21 out of 21 cancers in women with advanced (metastatic) breast cancer
- Detected 5 out of 5 cancers in women who were newly diagnosed with advanced (metastatic) breast cancer
- Detected 8 out of 8 cancers in women with breast cancer involving more than one lymph node
- Detected 5 out of 5 cancers in women with breast cancer that did not involve any lymph nodes
- Detected 4 out of 5 cancers in women with ductal carcinoma in situ (DCIS), an early- stage breast cancer
Ruled out breast cancer in 26 of 28 women with normal or benign breast conditions .
Though the preliminary results of the blood test are promising, other health care professionals caution that the results were produced among a very small sample of women and that Matritech knew the condition of all of the women in the study ahead of time. Clifford Hudis, MD, chief of breast cancer medicine services at Memorial Sloan-Kettering Cancer Center, warned that even if a test has a low rate of false-positive results in a small setting, it could translate to thousands of false-positive results if a million women are tested. False-positive results occur when a test indicates the presence of disease when no disease is present.
A spokesperson for Matritech said that the company hopes to begin a much larger clinical trial by the end of 2000. If the results of the larger trial continue to be promising, additional clinical trials will most likely follow.
Even if the blood test proves successful in other clinical trials, it will probably not replace mammography, the only exam currently approved by the U.S. Food and Drug Administration (FDA) to screen for breast cancer in women with no signs of the disease. Rather, the blood test will most likely be used in conjunction with mammography to improve the breast cancer diagnosis process . For example, the blood test may be used on a patient whose mammogram returned indeterminate (ambiguous) findings.
Currently, NMP blood tests are approved to help screening for bladder cancer in the United States, Europe, and Japan.
- The June 1, 2000 Matritech, Inc. press release, “ Matritech Reports ‘Proof of Clinical Concept’ for Breast Cancer Blood Test is Complete,” is available at http://www.matritech.com/pressreleases060100.asp
- The June 2, 2000 Reuters Health report, “Experimental
Blood Test May Signal Breast Cancer,” is available at
http://www.reutershealth.com/cgi-bin/frame?left=/
elinel.asp&right=/archive/2000/06/02/eline/links/20000602elin018.asp- To learn more about mammography and other breast imaging tests used to help detect breast cancer, please visit http://www.imaginis.com/breasthealth/advances.asp
- To learn more about signs and symptoms that may indicate breast cancer, please visit http://www.imaginis.com/breasthealth/bse.asp#breast_changes
