The Octava™ Tests
EventusDx researchers have developed the Octava™ tests as the first in a new class of rapid, accurate and cost-effective blood tests that measure breast cancer-specific autoantibodies to detect the presence or absence of breast cancer. The Octava tests are designed to be used in conjunction with annual screening mammograms. They have been validated by clinical studies conducted at cancer centers in the U.S., Israel and Italy that analyzed blood samples from over 800 women. These women all had positive mammograms and their breast cancer pathologies were verified by biopsy.
An article reporting the results of a large clinical study of the Octava Blue test conducted in collaboration with researchers at the MD Anderson Cancer Center and other leading breast cancer specialists was recently published in the peer reviewed journal, Biomarkers in Cancer. The 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. It showed that the Octava Blue test was accurate, correctly identifying the presence or absence of breast cancer with very high sensitivity and good specificity.
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. False positive mammograms are common. Studies show that 80% of the biopsies performed after an abnormal mammography result are negative, indicating that no cancer is actually present. Octava Blue has the potential to help confirm true positive results and reduce the number of unneeded biopsies by up to 50%, saving many women the anxiety and invasiveness of the biopsy procedure while also reducing unnecessary medical costs.
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. Studies estimate that between 10% and 30% of negative mammography results are inaccurate, missing cancers that are actually present. False negative results are more common in the 40% of women with dense breast tissue. Octava Pink is designed to reduce women’s concerns about missed cancers, providing reassurance to women whose negative results are accurate, while enabling many of the misdiagnosed patients with false negative results to seek additional diagnostic information and follow-up.
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.
The Octava tests require only a simple patient blood sample that is sent to EventusDx’s certified central laboratory, where it is tested and analyzed using the proprietary Octava technology. Results are available within several days.
The Octava Pink and Octava Blue tests have been approved for marketing in the European Union, and marketing approval in Israel and several countries in Asia is expected soon. The Octava Pink test is currently available as part of a pilot program being conducted with selected physicians in Italy and Israel. Information on participating in the pilot program is included in the section below.
EventusDx is conducting additional Octava clinical studies for its planned 2014 submission to the FDA for approval to market the Octava tests in the U.S.
Pilot Availability of Octava Pink Test in Italy and Israel
Eventus Diagnostics is currently partnering with breast cancer specialists in Italy and Israel to make the Octava Pink test available on a pilot basis. The Octava Blue test will be added in the pilot program soon. For more information on accessing the Octava Pink and Octava Blue tests, please contact us at email@example.com.
Broader availability of the Octava Pink and Octava Blue tests in Europe is expected during 2014.