Peer-Reviewed Publication Confirms Eventus Diagnostics' Octava™ Blood Test Can Accurately Detect Breast Cancer

MIAMI, Nov. 25, 2013 /PRNewswire/ -- Eventus Diagnostics, Inc. (EventusDx) today announced publication of a peer-reviewed study that confirms the diagnostic accuracy of its Octava™ blood tests designed for use with screening mammography.¹ The study showed that the Octava™ Blue test has excellent sensitivity and good specificity in helping to identify whether or not women who have had an abnormal mammography result actually have breast cancer. The study was conducted by researchers at Eventus Diagnostics and at major cancer centers in the U.S., Italy and Israel.

The Octava breast cancer tests are the first in a new class of rapid, accurate and cost-effective immune system-based blood tests that detect the presence or absence of cancer by measuring ratios of autoantibodies produced by the body in response to the presence of tumor-specific antigens. They have been validated in large multinational clinical studies and are CE marked in the European Union. Pilot distribution programs are currently underway in Italy and are planned for other E.U. countries and Israel.

Dr. Marvin Rosenberg, President of Eventus Diagnostics U.S., commented, "This publication represents a major milestone and proof of concept for our Octava blood tests, which we believe have the potential to transform the diagnosis of breast cancer. The enthusiastic response by physicians and patients to our Octava pilot distribution program highlights the large unmet need for improved breast cancer diagnostics that are non-invasive, risk-free, accessible and affordable. We are initiating additional clinical studies to support a U.S. regulatory filing and look forward to collaborating with a variety of partners to make this important new diagnostic approach available to women worldwide."

The Octava Blue test is designed to provide additional information to help clinicians interpret abnormal mammography results. Approximately 80% of the breast biopsies triggered by abnormal mammograms are negative, indicating no cancer is actually present. These biopsies are invasive and painful, and they generate significant unnecessary costs to the health care system. The Octava Blue test helps confirm true positive mammography results with high accuracy, and it could lead to reductions in unnecessary biopsies caused by false positive results by 50% or more. 

The newly published study assessed blood samples from more than 500 women who had positive mammograms followed by breast biopsy to definitively ascertain whether or not they had breast cancer.

Study co-author Therese B. Bevers, MD, Professor of Clinical Cancer Prevention and Medical Director of the Cancer Prevention Center at the University of Texas MD Anderson Cancer Center, noted, "This study shows that measuring cancer-associated activity of the immune system has the potential to improve the diagnosis of breast cancer. Screening mammography has been an important tool for detecting cancer when it is most treatable, but its accuracy is not optimal. Non-invasive, rapid, affordable blood tests such as Octava Blue that provide additional information to physicians and patients could be valuable in improving the accuracy and cost-effectiveness of breast cancer screening."

The second Octava test, Octava™Pink, is intended to provide additional information to the physicians of women who have received a negative mammography result. False negative results are common, particularly in the large population of women with dense breast tissue. Overall, screening mammograms miss an estimated 10%-30% of breast cancers. Clinical studies show that Octava Pink detects true negative mammography results with high accuracy, while identifying at least half of the missed breast cancers. It is expected to provide reassurance to those women whose negative results are accurate, while alerting many of the misdiagnosed patients and their medical providers to seek additional diagnostic follow-up.

EventusDx is currently analyzing the Octava tests at its ISO-certified laboratory in Israel using a microarray-based platform. The company is further refining the Octava technology with the aim of achieving even better accuracy in future versions of the tests, as well as applying it to other cancers. For more information on the Octava breast cancer tests, visit the EventusDx website or email [email protected].

Breast cancer is by far the most common cancer in women worldwide, with an estimated 1.6 million new cases diagnosed in 2010. The National Cancer Institute estimates that 232,340 new cases of breast cancer will be diagnosed in the U.S. this year, and an estimated 40 million screening mammograms will be performed. 

1. Yahalom et al. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomarkers in Cancer 2013:5 71–80 doi:10.4137/BIC.S13236.

About Eventus Diagnostics:
Eventus Diagnostics, Inc. (EventusDx), a U.S. company headquartered in Miami, FL with a wholly owned R&D subsidiary in Israel, is developing a new class of immune-based blood tests for the detection of cancer. The company's Octava™Pink and Octava™ Blue tests are CE marked in the E.U. to provide additional information to help physicians better interpret breast cancer screening results. The Octava tests are the first in a new class of rapid, accurate and cost-effective blood tests based on EventusDx's patented technology that measures disease-specific autoantibodies to detect whether cancer is present. For more information, visit www.eventusdx.com.

SOURCE Eventus Diagnostics, Inc.