Women have consulted with their physicians for generations to gain insight about the risks of breast cancer and to educate themselves about the optimal protocol for early detection and treatment. Unfortunately, this aspect of the doctor-patient relationship is rendered more complex by the absence of very accurate, safe and reliable testing methods. Some physicians persist in believing that mammograms offer the ideal option. However, female patients are justified if they are bewildered by the controversy that hangs over the accuracy of mammograms and how often they ought to be administered.
In the absence of more accurate tools for early breast cancer detection, a modicum of uncertainty is destined to persist. Tools of greater accuracy are also needed because the sooner physicians are capable of detecting breast cancer in their patients, the greater the range of available treatment options.
This problem raises the question of what sort of role technology might play in the solution. As it turns out, steps are underway at Seattle-based Atossa Genetics, Inc. to commercialize its recently developed, FDA-cleared diagnostic device that can be used to painlessly collect samples that are then be tested in Atossa’s wholly-owned laboratory. The test can identify women with reversible, pre-cancerous changes that place them at high risk of future breast cancer, and then offer them a treatment for the precancerous changes before they become malignant.
The test, named the ForeCYTE Breast Health Test, entails the use of an FDA-cleared, patented device, resembling a breast pump in appearance, that collects nipple aspirate fluid for cytological testing in women between the ages of 18 and 73. The fluid collected in this way can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. The procedure is noninvasive, virtually painless for the patient, and takes only about 10 minutes to perform. The collected specimens are subsequently tested in Seattle, WA at the National Reference Laboratory for Breast Health, a subsidiary of Atossa Genetics. If required, precancerous changes can be addressed with lifestyle intervention or pharmaceutical treatment. For example, in women with atypical hyperplasia, lifestyle changes have been shown to reduce future risk of breast cancer by as much as ten percent and treatment with tamoxifen produces a reduction of greater than 80 percent in the development of future breast cancer.
Ultimately, the precancerous changes may be treated with intraductal therapy that is also being developed by Atossa. The therapeutic system, which is currently in the research phase, will provide pharmaceutical formulations that can be introduced into a “sick duct” with an FDA-cleared microcatheter to treat the cancerous condition or reverse the pre-cancerous changes before they turn malignant. This technique avoids treating the entire patient with powerful and toxic drugs; instead, it acknowledges that the problem lies with a milk duct that is two inches in length and the diameter of a strand of angel hair pasta.
Atossa is foreseeing additional technologies for improved treatment of breast cancer. For example, one test, intended for survivors of breast cancer, offers preliminary warning about the presence of circulating breast cancer tumor cells in a simple “liquid biopsy” blood specimen. The test identifies these cells and can be harnessed directly after a woman starts breast cancer therapy, or at the time of diagnosis or biopsy, in order that she and her healthcare provider can make more informed decisions about effective options for treatment. The test could also be used for recurrence monitoring and whenever a treatment decision needs to be made.
A further test currently under development by Atossa employs genomic analysis to offer insights to enhance the effectiveness of breast cancer treatment for women who have early-stage breast cancer. This test provides genomic evaluation of risk for recurrent breast cancer and therapy selection, evaluating a greater number of genes for more informed patient management. The report generated by this test indicates the potential for cancer recurrence and offers a personal profile that can help pinpoint the ideal course of treatment.
If Atossa’s technologies are successful, with precancerous changes diagnosed during routine checkups and then treated immediately afterward, female patients who are at risk for breast cancer might be given a safer and more dependable route to long-term health.
Steven C. Quay, M.D., Ph.D., FCAP is Chairman, President and Chief Executive Officer of Atossa Genetics, Inc. and Director of the National Reference Laboratory for Breast Health. He can be reached at Steven.Quay@AtossaGenetics.com