MIAMI, FL – As the gold standard for breast cancer screening has come under scrutiny in recent years, a new class of imaging devices, antibody tests and gene tests to detect breast cancer has been making its way through the pipeline.
One of those is a blood biomarker test that Eventus Diagnostics says could potentially help physicians identify false negative and false positive mammogram results.
EventusDx has just closed in on a $2.7 million round of financing from undisclosed investors to move forward with a large international clinical study that would support its application for FDA clearance.
The technology is a chip-based test that analyzes a small blood sample to look for autoantibodies produced by the immune system in response to the presence of tumor-specific antigens. But instead of just looking for the presence of those autoantibodies, EventusDx’s proprietary algorithms measure the ratios of some 30 to 40 of them – a key reason company executives say the test is so accurate.
In the U.S., the company is positioning its test, Octava Pink, as a next-step screening for women with dense breast tissue who receive normal mammogram results. More than 30 percent of breast cancers in women with dense breast tissue are missed by mammography, said Dr. Marvin Rosenberg, the company’s president. The blood test would be a noninvasive way to double-check the mammography findings, or even detect circulating tumor cells before the tumor is visible in a mammogram, without exposing women to radiation.
In a clinical study published last year that used samples from more than 500 women, the test correctly identified presence or absence of breast cancer with 95 percent sensitivity and 50 percent specificity. Rosenberg said the company’s R&D team has continued to add antigens to the panel since that study and expects to see a greater level of accuracy in the upcoming study.
Another application of the technology, called Octava Blue, is being developed for use to help physicians determine whether a biopsy is really needed when mammogram results are abnormal. Studies have estimated false-positive rates with mammography as high as 60 to 70 percent.
A number of other companies are developing gene-based tests for breast cancer, but Don Martin, Eventus Dx’s chief business officer, said an assay test is a simpler and less costly approach. “It’s a test that will probably end up having an end-user cost of a few hundred dollars,” he said.
But first, EventusDx will try to demonstrate improved accuracy of its test in identifying breast cancer in a study involving more than 1,400 women. Rosenberg said the protocol for the upcoming study has been finalized as is under review by cancer centers in the U.S., Canada, Israel and Italy.
Octava Pink has already been CE Marked, and pilot distribution programs are under way for Octava Pink in Italy and Turkey. A full commercial launch is underway in Israel.
EventusDx is based in Miami with an R&D subsidiary in Israel.