Eventus Diagnostics, Inc. (EventusDx) today announced completion of a $2.72 million financing. The financing was led by a new family office private investor, and existing investors also participated. Proceeds of the financing will mostly be used to support the continued development and commercialization of the company's Octava™ breast cancer tests.
The Octava 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 in response to the presence of tumor-specific antigens. The Octava™ Pink and Octava™ Blue tests are designed to be used in conjunction with annual screening mammograms. They provide additional information that enables women and their physicians to better assess the validity of their mammography results.
The Octava tests are CE marked in the European Union and were recently approved for marketing in Israel by the Ministry of Health. Pilot distribution programs for the Octava Pink test are currently underway in Italy and Turkey and are being established in a number of other E.U. territories. A full commercial launch of Octava Pink has begun in Israel.
Dr. Marvin Rosenberg, President of Eventus Diagnostics U.S., commented, "There is growing recognition that the contributions to women's health worldwide from widespread use of screening mammography are off-set by the fact that it is an imperfect tool, producing too many false negative and false positive results. Our Octava blood tests are designed to address this issue, confirming true negative and true positive findings post-mammography with high accuracy, while identifying a substantial number of the inaccurate results."
The Octava tests have been validated in large multinational clinical studies that included over 800 women. The published results of a large clinical study conducted in collaboration with researchers at the MD Anderson Cancer Center and other breast cancer centers confirmed the accuracy of the Octava Blue test, showing that it correctly identified the presence or absence of breast cancer with high sensitivity and good specificity.
Dr. Rosenberg continued, "Our Octava Pink pilot distribution programs are generating considerable interest around the world. We are currently implementing our next set of clinical studies with leading academic centers to further validate the Octava tests and produce the additional data needed for regulatory submissions to the U.S. Food and Drug Administration. In particular, there is growing appreciation of the unmet need for improved breast cancer screening for women with dense breasts who are at greatest risk of missed diagnoses. We expect to initiate a large-scale international study of Octava Pink in this population later this year. We appreciate the support of our new and existing investors in providing us additional financial resources as we move on multiple fronts to expand access to the Octava breast cancer tests."
The Octava Pink test is designed to help physicians confirm true negative mammography findings with very high accuracy, while helping to identify the presence of cancer in many of the cases where mammography produces a false negative result and cancer is actually present. False negative results are of particular concern in the estimated 40% of women with dense breast tissue. The Octava Blue test is designed for use
in conjunction with screening mammograms to help physicians confirm true abnormal mammography results with high accuracy, while also helping to reduce the large number of unnecessary biopsies caused by false positive results.
The Octava tests require only a simple patient blood sample that is tested and analyzed at EventusDx's ISO-certified central laboratory. Results are available within several days.
EventusDx is further refining the Octava technology with the aim of achieving even better accuracy in future versions of the tests, and it is applying the approach to develop tests for other cancers.
Eventus Diagnostics, Inc.