A More Definitive Breast Cancer Test?

Jerusalem —Tamar, an Israeli woman in her early 50s, is at high risk for breast cancer, but the very dense tissue in her breasts prevents the most widely used tests — mammograms and ultrasounds — from offering a definitive “all-clear.”

“I have a precancerous condition and every time I’ve gone for a mammogram and ultrasound and they showed nothing, I wondered if they’d missed something,” she told The Jewish Week in a telephone interview from her home in Tel Aviv.

That’s why Tamar, who adopted a pseudonym to safeguard her privacy, was excited to learn about a new screening test that, when used in conjunction with a mammogram, provides a much more definitive diagnosis, according to its inventors at Eventus Diagnostics, Inc. (EventusDx).

Registered in the United States, with its R&D center in Jerusalem, Eventus develops blood tests that measure cancer-specific autoantibodies present in people with cancer.

The Octava Pink test is appropriate for women whose mammogram comes back “negative-for-cancer” but whose physicians seek confirmation. In clinical trials at top hospitals in Israel, the U.S. and Italy the Octavia Pink test “was 97 percent accurate in informing a patient she doesn’t have breast cancer,” according to Dr. Marvin Rosenberg, the company’s co-founder and president.

Although researchers around the world are working on blood tests to diagnose cancers, “most companies are working on the basis of genetics,” Rosenberg said. “We believe we are the only ones who have developed a diagnostic test based on the immune system’s response to specific cancers.”

Following eight years of research and development, the test is now available to consumers and their physicians in Israel and Italy, and will soon be marketed in Europe and Asia. The company hopes to win approval for the test from the U.S. Food and Drug Administration within three to five years for the test to be part of breast cancer screening; approval would depend on the outcome of advanced clinical trials already in the works.

To develop the test, Eventus’ biologists compared the blood of hundreds of women diagnosed with breast cancer to blood taken from healthy women. As hoped, they discovered differences in their autoantibodies — antibodies, or proteins, produced by the immune system that are directed against one or more of the individual’s own proteins. The proteins were also associated with the development of cancer.

Other autoantibodies have been implicated as the cause of several autoimmune diseases.

To perform the work, Eventus invented a type of nanotechnology that allows nearly 100 blood samples to be tested at the same time, in just a few hours.

To find breast cancer’s specific “immunological profile,” the researchers examined the autoantibodies of intestinal cancer patients and women diagnosed with ovarian cancer.

“The differences were significant,” said Alon Hayka, Eventus’ co-founder and president. Based on this research, Eventus is developing blood tests to detect several cancers, including lung, colon, prostate and ovarian cancers. The company plans to commercialize its products in collaboration with corporate partners in the U.S., Europe and Asia.

Dr. Moshe Simcha, a breast surgeon at Ichilov Hospital in Tel Aviv, called the test a “breakthrough” that helps fill a gap in breast cancer diagnosis, especially for younger women, for whom “no imaging techique is sufficient.”

“There are too many misdiagnoses and we clinicians are starving for anything that will help us fill the gap and lead to early diagnosis,” he said. “Octava Pink is a new test that has the potential to do this.”

Eventus is also developing a second blood cancer test, called Octava Blue, which is designed to confirm abnormal (“positive”) mammogram results and hopefully reduce the number of unneeded biopsies. An estimated 80 percent of women with abnormal results from a screening mammography who receive a breast biopsy are determined to be false positives, meaning they do not have breast cancer, Rosenberg said.

The company, which is privately funded, “is seeking to raise additional capital,” Rosenberg said.

Octava Pink, the company’s premiere product, has a potentially huge market. According to American Cancer Center (www.cancer.org) “a false-negative mammogram appears normal even though breast cancer is present.” Overall, screening mammograms “miss about one in five breast cancers.” False negatives “occur more often among women with dense breasts.”

Making matters worse, “false negatives are more common among younger women,” ACC notes.

While Eventus views Octava Pink as a complement to mammograms, especially for women with dense breasts, there is nothing to prevent a person — including one whose insurance company refuses to pay for a mammogram because she is under age of 50 — from taking the blood test and, if it comes back suspicious, pressing for a mammogram.

Rosenberg said that after Eventus submitted its protocol outlining its clinical trials and goals to the FDA, the American agency “told us they consider our test to be a screening test, not a diagnostic test.” Mammograms are the only FDA-approved breast cancer screening test.

If approved, “we would be the only the second approved breast cancer screening test, along with mammography. That’s big news.”

Regardless of how the test is ultimately classified in America, Tamar said she is grateful it’s already available in Israel.

“When it comes to health care, Israel is so much more advanced than America,” said Tamar, a dual U.S.-Israeli citizen.

Even so, she had no idea the test, which has been available since September 2013 existed until her doctor said she would be the “perfect person” to take it.

I said, ‘What’s the catch?’”

The only catch was that although the Ministry of Health recently approved Octava Pink, its cost is not yet subsidized by Israel’s health funds (though they are considering it, Rosenberg said). Tamar paid 950 shekels (about $257).

“Thank God the test was negative, so I could sleep easily,” she said. “For me the peace of mind was worth the expense.”

editor@jewishweek.org