“You’re fine” is what every woman wants to hear after her mammogram. But in 20 percent of those cases, they aren’t fine at all – cancer is there, but undetected by the exam. Octava Pink, a new blood test that confirms true negative results, will give women more certainty about their results. The test, approved in Europe, is about to undergo a second major clinical trial in the US to get FDA approval for use here.
Octava Pink is being developed by EventusDX, an American holding company headquartered in Florida, with Eventus Diagnostics, its Research and Development subsidiary in Israel. Alon Hayka, CEO of Eventus Diagnostics, said they have been working with the FDA from the beginning of their research for guidance on how to proceed in order to get the best data. An initial study was done with the MD Anderson Cancer Center and Octava Pink received the CE designation for introduction in Europe last May. It has been introduced in Israel, Canada and Italy and will soon be available in France, Spain and Turkey. Octava Pink is about to be tested in a big, multi-center clinical study to meet the pathway for FDA approval and introduction in the US.
Hayka said Octava Pink helps diagnose breast cancer in women with dense breast tissue, estimated to be forty percent of all women. On a mammogram, tumors are white and so is dense tissue, so abnormalities can be hidden, resulting in a high number of false negative mammograms.
Octava Pink “is a completely different modality,” Hayka said. “It detects antibodies that are associated with tumors. We have screened close to 60,000 antibodies and have found a few thousand that are associated with breast cancer. This test has 95 percent sensitivity and 75 percent specificity, putting it in the range of MRI. Together with mammography, this will give women a high level of security that nothing is missed.”
As CEO of Eventus Diagnostics, Hayka is responsible for the business administration and marketing of the products. He has been an entrepreneur in the medical field for twenty years and began his involvement with the research leading to Octava Pink seven years ago. He expects the data for the coming Octava Pink trial to be submitted by the end of this year and the results in six – eighteen months.
Hayka said that while the research is challenging, Octava Pink will be easy to use. “The test is simple and fast. You will take the test today and tomorrow you will have results.”
By Bracha Schwartz
