Power3 Medical Products this week said it is launching its blood-based breast cancer test in the Middle East, making it the first proteomic test for the early screening and diagnosis of the disease.
The company, based in The Woodlands, Texas, has signed an agreement with Financial Advisory Houses’ Medical Equipment Suppliers division to market and distribute the test, called BC-SeraPro, in Bahrain, Egypt, Iraq, Jordan, Kuwait, Lebanon, Saudi Arabia, Oman, Qatar, Syria, the United Arab Emirates, and Yemen.
While most of Power3’s attention recently has been directed at developing a proteomics diagnostic for Alzheimer’s disease [See PM 09/14/06 and 11/30/06], the company has been developing BC-SeraPro for the past three years.
In 2004, the company purchased ProteEx, a developer of breast cancer biomarkers. Power3 chose not to further develop the company’s nipple aspirate fluid test because it proved too difficult to obtain the necessary proteins from the samples, Steven Rash, CEO and chairman of the company told ProteoMonitorthis week. Instead, the BC-SeraPro is blood-based. The company used 2D gel electrophoresis and image analysis to identify the breast cancer biomarkers on which its test is based. The same approach was used to develop its Alzheimer’s test.
Power3 may be the first to market with its test, but it has competition waiting in the wings. Biomarker Technologies, now owned by Provista Life Sciences, has developed a protein biomarker test for breast cancer, called the BT Test, which is currently undergoing clinical tests for possible commercialization. Digilab BioVision is also developing a proteomics breast cancer test. And while Miraculins halted work on its breast cancer test, a company official told ProteoMonitor in June that it may restart development in 2008.
The BC-SeraPro is also entering a segment of the oncology market that already boasts a comparatively successful test: mammograms. By some measures, mammograms have reduced breast cancer mortality by 35 percent for woman aged 50 and above, and by at least 25 percent for women between 40 and 50. But like every other diagnostic and screening exam, mammograms have their limitations, including false positives and negatives.
The BC-SeraPro was developed as an “augmentation” to mammograms, Rash said.
“We’re in the high 80’s [to] 90 percent sensitivity [and] specificity, much better than mammography already,” Rash said. “Plus mammograms are not recommended for women under 40 because their breasts are too dense, so you’re not able to read their test results.”
By comparison, the BC-SeraPro works equally well for women under 40, Rash said.
In a report issued in June, the Cohen Independent Research Group estimated the market for early detection of breast cancer at $7 billion just in the US.
Power3 officials said the company chose the Middle East as the initial launch site for BC-SeraPro because of the high incidence of breast cancer in the region. No solid statistics exist on the rate of incidence of breast cancer in the region, but according to the Susan. G Komen for the Cure foundation, the mortality to incidence rate in the Middle East, 44 percent, is higher than that in the US and many other countries.
“It’s the right market at the right time for us to proceed and perfect any issues that may come up before we launch into the much larger markets.”
“There’s a definite medical need there,” said Ginger Meyers, director of clinical programs at Power3.
Rash also said that because healthcare is free to patients in the region, fewer barriers exist to getting the test to them.
“It’s the right market at the right time for us to proceed and perfect any issues that may come up before we launch into the much larger markets,” Rash said. In a press release, he called the agreement with Financial Advisory House “an important milestone in our development and transition from a research and development company to a diagnostics company with commercially viable products.”
In the release, Ebrahim Al-Lengaw, chairman and CEO of FAH, based in Bahrain, said “With this innovative technology breast cancer patients and physicians will have a powerful new tool for use in the earlier detection and treatment of breast cancer in combination with other existing technologies.”
Rash declined to comment on the company’s plans to launch the test in the US. In the press release, the company said that it is seeking other distributors for the test and is “currently in discussion with several international and domestic partners as we implement our strategic plan to expand our geographical distribution of the test and other diagnostics tests currently in the pipeline.”
In April, Power3 received Clinical Laboratory Improvement Amendments certification to begin offering blood-based tests. As long as BC-SeraPro results are analyzed in Power3’s laboratories, the test does not require approval from the US Food and Drug Administration, Rash said.
The company, however, plans to develop the test as an in vitro diagnostic multivariate index assay test, which would require FDA approval.
In the spring, the company formed a joint venture contract research organization with NeoGenomics to commercialize Power3’s portfolio of biomarkers. NeoGenomics is not involved in this week’s launch, however.
In addition to the launch, the company late last year filed a patent application with the US Patent and Trademark Office for 12 protein biomarkers for breast cancer. According to the Cohen research group, if approved, the biomarkers would help Power3 to further develop blood tests for the early detection of the disease, which would enable the company to “capture a significant share in the market going forward.”
As for its Alzheimer’s based diagnostic, Rash said the product is still in pre-commercialization development. Last month, the company’s stock began trading on Nasdaq’s Over-the-Counter Bulletin Board again, two years after the exchange delisted Power3’s shares from the OTC BB for failing to file its annual report on time.