Octava Pink Octava Pink Octava Pink is a simple breast cancer blood test with results in three hours. (All photos courtesy Eventus)

Blood test may be able to detect breast cancer before mammograms can

Israeli company hopes to provide earlier and more accurate diagnoses.

One in nine women will contract breast cancer at some point during their lifetime. For the most effective treatment, early detection is key. A life-sciences startup based in Israel has developed a set of blood tests that can detect breast cancer before a tumor has even formed, as well as help physicians identify false negative and false positive mammogram results.

The company, Eventus Diagnostics Ltd, says that up to a third of the time mammograms appear normal even when cancer is present. A false negative mammogram means a patient loses valuable time before the cancer is diagnosed and treatment is started. False positive mammograms, meanwhile, often result in unnecessary biopsies.

Octava Pink is a simple, non-invasive blood test administered by a physician and then sent to a certified laboratory for analysis. Results can be ready in as little as three hours, allowing for quick, accurate confirmation of negative mammograms.

Using blood biomarkers - autoantibodies that are produced in response to specific breast cancer antigens - the test can detect instances of cancer that are so small, a mammogram may not be able to find them.

A second test, Octava Blue, is designed to determine true positive mammogram and breast biopsy results.

Octava PinkThe test is currently available in Israel and Italy, and should be FDA-approved in the U.S. soon.

The project was founded by Alon Hayka, Dr. Marvin Rosenberg and molecular biologist Galit Yahalom, who have headed up the 15-person team that developed the Octava tests. More than a thousand women worldwide participated in a series of clinical trials that were carried out in leading medical centers around the world, including MD Anderson Cancer Center in Houston, Texas, Carmel and Kaplan Hospitals in Israel, the European Institute of Oncology in Milan Italy, and the Mediterranean School of Oncology in Chietti, Italy.

The researchers collected data from women who had been diagnosed with breast cancer, as well as those that were healthy. They analyzed the data looking for antibodies to breast cancer antigens in the immune system. In addition, they studied immune-system activity in men and women with intestinal cancer and ovarian cancer to understand the distinction from breast cancer. The researchers were able to determine the characteristics of women with breast cancer, and compare them to those of the healthy group.

"It has been reported in the literature that breast cancer-specific auto antibodies can be detected 3-4 years before the cancer can be seen with mammography," Barbara Lindheim, an Eventus company spokesperson, told From the Grapevine. "With larger scale confirmatory tests, we believe that we will demonstrate and confirm that Octava can detect the presence of early breast cancer long before it can be seen with imaging."

According to the company, the test can identify as many as 75 percent of breast cancer patients whose cancer was not detected by routine mammography screening. It can confirm true negative mammogram results with more than 95 percent accuracy. The company says it has validated those numbers internally, and plans to validate them externally in upcoming clinical studies.

Researchers say both tests use proprietary algorithms to measure the ratios of 30 to 40 different auto antibodies, which is why the company says the test is so accurate. The tests are particularly useful for women with dense breast tissue, which makes detecting breast cancer even harder.

Genetic testing for cancer is expensive, costing several thousand dollars or more per test. The Octava tests are the first in a new class of quick, accurate and cost-effective immune-based blood tests that measure disease-specific auto antibodies to detect whether cancer is present. Additionally, the company says the technology could be used to develop diagnostic kits for many other cancers.

Eventus recently announced $2.72 million in new financing thanks to a private investor. The money will be used for further development and commercialization of the tests. Octava Pink is already approved and commercially available for use in Israel and Italy. In the United States, planning for clinical trials is under way - the company hopes to begin enrolling patients for the trial this year. The company says the tests could be approved by the U.S. Food and Drug Administration as early as 2016.

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