A new blood test that can aid in early breast cancer detection will increase in availability by October, which just happens to be Breast Cancer Awareness Month. So far, the Mammastatin Serum Assay (MSA) test has been limited to just a handful of labs in the United States, but with the impending sale of the product by Biotherapies, Inc. to Genesis Bioventures, the marketing of the product will begin with a roar.
And that’s a roar of applause from the one out of eight women that will be diagnosed with the potentially fatal disease, as well as some hand-clapping from their loved ones. Dr. Paul Ervin, Jr., Ph.D., the founder of Biotherapies who developed the MSA at the University of Michigan Cancer Center, is excited about using the protein Mammastatin not only for the blood tests, but for long-term therapeutic care as well. Testing has been extremely positive for even late-stage breast cancer patients.
“The potential of this technology to identify women at risk to develop breast cancer is enormous,” said Ervin. “Based on initial studies, it may also have the potential to identify women who already have the disease.” Ervin worked on the development of Mammastatin for eight years while he was a research scientist at the university laboratory, and founded Biotherapies four years ago.
Mammastatin is a protein that is present in healthy women and controls abnormal cell growth in breast tissue. Women who have little to no Mammastatin protein levels are at a high risk for breast cancer. If a women tests toward the negative on her MSA, she will then be urged to follow-up and be more diligent with exams or other medical testing to check for any signs of the disease. As a therapeutic, Mammastatin is injected within a saline solution on a daily basis to restore the protein to a healthy level. Thus, a patient may be able to use the words “long-term life expectancy,” instead of carrying the weight of an impending death sentence that befits the virulent nature of advanced breast cancer.
Says Ervin, “If breast cancer comes back a second time, it’s a tough one to beat. It will, well, it’s gonna getcha.”
In pre-clinical tests, women who were given the injections had cancer that had significantly spread to other tissues and a life expectancy of less than two months. Some patients took the treatment continuously along with their other therapies for as long as four years. Most of the women taken off of the Mammastatin have died.
Current testing is also showing a positive correlation between Mammastatin therapy and the current pharmaceutical favorites known as estrogen antagonists, such as the drug Tamoxifen. Because the protein is non-toxic and non-invasive, it can potentially be used along with or as an adjunct to traditional therapies such as the anti-estrogens and other chemotherapy or radiation treatments. Used alone, with chemotherapy, or as an adjunct to hormone therapy, the data suggests not a cure, but a control for the deadly disease.
Breast cancer is a mighty killer of women, just trailing lung cancer for sheer number of deaths. Mammograms and self-examination are the only current tools available to detect a breast mass. The MSA, generally given to women over the age of thirty, can help to evaluate risk factors and promote lifestyle changes for those at a higher risk. Eventually, the drug could be a preventative.
“This can benefit every adult female and lets all women win,” said Ervin.
Mammastatin is now being produced from natural tissue, but Biotherapies is working on a synthetic version to ease in the manufacturing process. According to Dr. Ervin, the test should cost about $150 to $195 when it initially hits the market.
The patent for the MSA is held by the University of Michigan. After Ervin founded Biotherapies, they merged with Genesis Bioventures (officially BioLabs, Inc.), and its portfolio company Biomedical Diagnostics introduced the technology to specialized labs. The first product was release in June of 2001.
Biotherapies is also testing related proteins that perform similar growth inhibitory functions in other frequent cancers such as prostate, skin and colon cancers.