Image: The Octava blood tests, developed for rapid, accurate detection of breast cancer tumors (Photo courtesy of Eventus Diagnostics).
A simple blood test has been developed as an easy, noninvasive method to detect breast cancer and is designed to be used in conjunction with annual screening mammograms.
The developed assay has been described as an accurate, cost-effective, immune system-based means of detection by measuring breast cancer-specific autoantibodies to detect the presence or absence of breast cancer.
The blood test has been validated by clinical studies conducted at cancer centers in the USA, Israel, and Italy that analyzed blood samples from over 800 women. The women in the trial all had positive mammograms and their breast cancer pathologies were verified by biopsy. The test measures cancer-specific antibodies produced by the immune system in response to the growth of tumors, and can be used both to quickly diagnose breast cancer before tumors become visible in mammogram, as well as identify false negative and false positive mammogram results.
The Octava tests were developed by Eventus Diagnostics’ subsidiary (Moshav Ora, Israel) and the two chip-based tests, called Octava Pink and Octava Blue, require the patient to donate a small sample of plasma to quickly determine the presence of the antibodies. The Octava Blue test is designed for use in conjunction with screening mammograms to provide additional diagnostic information 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 Pink test is designed to provide additional diagnostic information to help physicians confirm true negative mammography findings with high accuracy, while helping to identify the presence of cancer in more than half of the cases where mammography produces a false negative result and cancer is actually present. The Octava Pink test can also provide additional information to address the estimated 5% of core needle breast biopsy results that represent false negative findings. The information from Octava Pink could help physicians detect at least half of those cases where cancer is actually present, possibly triggering an additional biopsy. Octava Pink may also be useful to physicians caring for women who will not or cannot receive mammograms.
Marvin M. Rosenberg, DDS, the president of Eventus Diagnostics, said, “The tests could be used by women with dense breast tissue who received normal mammogram results, or by women hoping to detect tumor cells without exposing themselves to radiation. Over 30% of breast cancer cases in women with dense breast tissue are missed by mammograms, a gap Eventus’ technology aims to address.” Eventus recently secured USD 2.72 million in funding to finance a large clinical study of the Octava tests to support its application for US Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance.
US Food and Drug Administration