Houston-based Power3 Medical Products plans to launch its BC-SeraPro breast cancer diagnostic in the US by mid-year.
The company initially launched the proteomics-based blood serum test in 12 Middle Eastern countries late last year through Bahrain-based supplier Financial Advisory House after gauging a significant medical need for early breast cancer detection in that region.
Power3 officials told Pharmacogenomics Reporter this week that the company is collecting data about the clinical and analytical validity of the test in the Middle East and in the US. The company is developing the test with Alan Hollingsworth at Mercy Women’s Center in Oklahoma City, and is obtaining tumor samples from the Woman’s Hospital of Texas in Houston. The test is currently being studied in a multi-site clinical-validation trial.
After the company publishes data about the test in peer-reviewed journals in the coming months, it will begin offering the test through its own CLIA labs. Ira Goldknopf, director of proteomics at Power3, said that the company is discussing regulatory submissions for the test with the US Food and Drug Administration.
In addition to the breast cancer test, Power3 recently announced it has formed a joint venture with Fort Myers, Fla.-based contract research organization NeoGenomics to commercialize blood-based tests for ALS, Alzheimer’s, and Parkinson’s diseases based on Power3’s biomarkers portfolio. Power3 has identified 59 biomarkers linked to neurodegenerative diseases and 22 biomarkers in breast cancers.
“These are biomarkers that are differentially expressed from the controls … in the case of these diseases, and the pattern of the differential expression is different for different neurodegenerative diseases, and it is different for breast cancer,” Goldknopf said.
Need In Middle East
Under the terms of Power3’s agreement with FAH, the BC-SeraPro breast cancer diagnostic will be marketed to physicians in Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia, Oman, Qatar, Syria, the United Arab Emirates, and Yemen. The blood sample will be analyzed in Power3’s CLIA-approved lab in Houston.
“There is a big need for breast cancer diagnostics in the Middle East,” Essam Sheta, director of biochemistry and the director of the CLIA lab at Power3, told Pharmacogenomics Reporter this week. “Women are very religiously conservative and they don’t expose themselves to other people, particularly men. Basically, they don’t go to the doctor unless it’s a woman. So, it’s much easier for them to take a blood sample instead of exposing their body to another person.”
“Women are very religiously conservative and they don’t expose themselves to other people, particularly men. Basically, they don’t go to the doctor unless it’s a woman. So, it’s much easier for them to take a blood sample instead of exposing their body to another person.”
According to Goldknopf, the decision to introduce the breast cancer test first in the Middle East was also spurred by the higher incidence of the disease in the region.
Two years ago, the National Cancer Institute compared cancer incidence in Cyprus, Egypt, Israel, Jordan, and the Palestinian Authority with incidence rates in the US. According to the resulting data, between 1996 and 2001, the NCI found that the breast cancer incidence was the highest among Israeli Jews, comparable to the U.S. population.
Particularly for women under age 55, the breast cancer rates for Israeli Jews were higher than in the U.S. population. This difference may be “related to the genetic mutations in the BRCA genes known to be more prevalent among Ashkenazi women,” the NCI said. While the three other countries had much lower rates of breast cancer compared to the US, it has been projected that by 2020, 70 percent of breast cancer cases will come from developing countries. genes known to be more prevalent among Ashkenazi women,” the NCI said. While the three other countries had much lower rates of breast cancer compared to the US, it has been projected that by 2020, 70 percent of breast cancer cases will come from developing countries.
Also late diagnosis of breast cancer also contributes to the higher incidence of breast cancer in the Middle East and throughout the Mediterranean regions, Goldknopf said. “Based on these reasons, we felt it was certainly worthwhile to introduce a blood test in the Middle East. Based on this test, physicians can then decided whether MRI or mammography is necessary, procedures which are also scarce in the Middle East,” he added.
Power3 is touting BC-SeraPro as “the first proteomics-based blood serum diagnostic test to be used for the early screening and diagnosis of breast cancer.” The test will cost approximately $500.
“What we are using as the platform for testing the samples in-house as a service is quantitative 2-D gel electrophoresis,” Goldknopf said. “In this process, we have ironed out all the reproducibility problems that have plagued this technology in the past.”
Power3 researchers use a combination of unilaterate and multivariate discriminant analysis to generate a “positive”, “negative,” or “indeterminate” probability score. “This is a biostatistical analysis, and the algorithms we have worked out and the reproducibility is really quite remarkable,” Goldknopf said.
At the San Antonio Breast Cancer Symposium in December, the company presented data from a study in which BC-SeraPro was used to analyze 98 samples obtained from two clinical sites – Mercy Women’s Center in Oklahoma City and Obstetrical & Gynecological Associates in Houston. Samples were obtained from 21 controls, 38 women with confirmed benign breast disease, and 39 patients at various stages of the breast cancer.
For the entire group of samples, the sensitivity and specificity of BC-SeraPro was 90 percent, meaning, the test was able to correctly identify 35 out of the 39 breast cancer patients, and 53 of 59 control samples or benign tumors.
According to a white paper written by Mercy Women’s Center’s Hollingsworth, “it is not believed that there is another breast cancer blood test at the threshold for commercial launch.”
However, “research in this area is ongoing at major biotech and pharmaceutical companies as well as smaller biotech companies using a variety of approaches such as SELDI-TOF and mass spectroscopy,” Hollingsworth notes in the paper. “The complexity and heterogeneity of breast cancer has made the development of such a test quite difficult.”
According to Goldknopf, the company plans to develop with partners a high-throughput, follow-on platform for the BC-SeraPro. “It will be an immuno-assay test based on the results from the two-dimensional gel electrophoresis, and the development of specific antibodies that will be able to recognize our biomarkers,” he added.
Power3 is currently trying to secure US and international distributors for the BC-SeraPro and other undisclosed diagnostics it has in its pipeline.
“A number of these biomarkers can also be very good drug targets,” making partnerships between Power3 and pharmaceutical companies very likely in the future, Sheta said.