I am scheduled for a yearly mammogram and I am not looking forward to it. The routine is a vise-like squeeze and an x-ray. I always told my sisters that if a man had to undergo the procedure with his male appendage, a new test would be soon be developed. Now progress toward a less uncomfortable and quicker method of diagnosis is in clinical trials.
Usually, if your mammogram shows a suspicious looking lesion, your doctor may order other blood tests or lab tests such an analysis of your urine or a biopsy of the suspicious area in your breast.
A mammogram,generally, can’t be certain about whether you have a malignancy not. The wait for results can be agonizing.
Summit Medical Group in Summit, New Jersey, (www.summitmedicalgroup.com) is reported to be the first breast center in the in the US mid-Atlantic states to conduct clinical trials with Videssa® manufactured by Podesta Pharmaceuticals . You can find other breast cancer clinical trials at: https://www.cancer.gov/about-cancer/treatment/clinical-trials/
One year, after my routine mammogram, I had frightening, long, flexible needles inserted in my breast to indicate, with an X- ray, the exact location of a suspicious lesion. Another year, after I had my routine mammogram, I was required by my physician to have a surgical biopsy.
Winnie Pollen, DO, a Summit Medical Group breast surgeon, who is leading the study says “Videssa® is exciting because it enables us to obtain information about lesions in breast tissue without having an invasive procedure.”
Another reason the development of Videssa® is exciting is because it uses biomarkers—specific molecules found in blood, urine, tissue and cerebral spinal fluid which reveal the presence or absence of certain cancers and for many other conditions such as diabetes and heart disease. It is expected to decrease medical costs by reducing the use of laboratory tests and other procedures to confirm and treat breast , prostate cancer, and other malignancies.
Alexander M. Castellino, PhD of The Mayo Clinic cited such cancer biomarkers in a February 27, news release: “Examples of tumor markers include prostate-specific antigen (PSA) for prostate cancer, cancer antigen 125 (CA 125) for ovarian cancer, calcitonin for medullary thyroid cancer, alpha-fetoprotein (AFP) for liver cancer and human chorionic gonadotropin (HCG) for germ cell tumors, such as testicular cancer and ovarian cancer.”
Provista Diagnostics, the developers of Videssa, is a privately held company. It is focused on developing and commercializing this new generation of proprietary blood-based diagnostic, prognostic and monitoring biomarker tests. The first commercial product, Videssa® is focused on early breast cancer detection, while additional products in development will target other women’s cancers such as ovarian and endometrial.
BioPharmaDIVE, a publication which covers biotechnology research, in its latest issue, quotes Harry Glorikan, author of “Commercializing Novel IVDS (invitrodiagnostics):” There is a new kid on the block. The field of molecular blood and tissue-based tests is exploding, mostly in cancer treatment but also, little by little in other areas including cardiovascular disease and neurological disorders.”
Not all researchers are convinced that Videssa is so stellar. The Mayo Clinic’s staff cautions on its website: “Tumor markers are also produced by some normal cells in your body, and levels may be significantly elevated in noncancerous conditions. This limits the potential for tumor marker tests to help in diagnosing cancer. Only in extremely rare circumstances would such a test be considered enough to make a firm diagnosis of cancer. The best way to use tumor markers in diagnosing cancer hasn’t been determined. And the use of some tumor marker tests is controversial.” (http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/cancer-diagnosis/art-20046459.)
Donald Northfelt, MD, Medical Oncologist and Hematologist says, however, on the Provista website (provista.com) “Videssa Breast® is the first protein-based blood test of its kind to provide early and accurate detection of breast cancer. Videssa Breast® may provide clarity to women who receive ambiguous mammography results and/or have dense breasts. With a simple blood draw, Videssa Breast® can help healthcare providers determine with greater confidence, whether further diagnostic procedures are warranted or provide assurance that a patient likely does not have breast cancer.”