Eventus Diagnostics, Inc. (EventusDx) today announced that it has received CE mark designation for its Octava PinkTM breast cancer test intended for confirmatory use in women who have received negative mammography results.
The National Cancer Institute (NCI) estimates that screening mammograms miss about 20% of breast cancers that are present at the time of the procedure, leading to false negative results. Studies suggest that the Octava Pink test confirms true negative mammography results with high accuracy, while identifying the presence of cancer in more than half of the cases when the mammography result is a false negative and cancer is actually present.
Octava Pink is designed to reduce women’s concerns about missed cancers, while also enabling many of those with false negative results to seek follow-up care and when indicated earlier cancer treatment. Octava Pink is the first in a new class of rapid, accurate and cost-effective blood tests that measure disease-specific autoantibodies to detect the presence of cancer.
EventusDx is partnering with breast cancer specialists in Italy and Israel to make Octava Pink available on a pilot basis. The Octava technology has been verified in clinical trials in over 800 women conducted at major cancer centers in Israel, Italy and the U.S. A peer-reviewed article reporting the Octava clinical data is currently being prepared in collaboration with a major U.S. cancer center and leading Italian and Israeli breast cancer specialists. Publication of the first article from this data set is expected later this year. A full launch in Europe will follow.
“We developed Octava Pink to address a serious shortcoming of mammography—the high rate of false negative results,” said Professor Benjamin Piura, MD, FRCOG, chief medical officer of Eventus Diagnostics and professor emeritus of obstetrics and gynecology at Ben-Gurion University of the Negev. “The Octava technology has demonstrated encouraging specificity and sensitivity levels in multi-site clinical testing in over 800 women. We expect that Octava Pink will identify at least half of all breast cancers in women who were mistakenly given negative mammography results, while providing welcome reassurance to women whose negative results are accurate.”
Studies indicate that women with dense breast tissue are more likely to have breast cancers missed by screening mammography. Overall about 40% of women who have mammograms are estimated to have dense breast tissue. Dense breast tissue is most common in younger women, but women of any age may have dense breasts. In the U.S., five states have passed dense breast tissue disclosure laws that require physicians to inform women with dense breasts that standard mammography in their case may not detect cancer. Similar legislation is pending in at least 11 other states and has also been introduced in the US. House of Representatives. These women and women considered to be at higher risk of breast cancer due to family history or other factors would be among those who could benefit most from having their negative mammogram results checked with Octava Pink.
Octava Pink can also address core needle breast biopsy results that are false negatives, estimated at about 5% of biopsies. Confirming negative biopsy results with Octava Pink should detect at least half of those cases where cancer is actually present, triggering additional diagnostic testing and treatment when appropriate. Octava Pink may also be useful to physicians caring for women who will not or cannot receive mammograms.
“Receiving CE marking for Octava Pink is an important milestone for our company,” said Alon Hayka, president of Eventus Diagnostics in Israel. “Octava Pink is designed to reassure women with true negative mammograms and to enable earlier diagnosis and treatment of breast cancer in women receiving false negative results.”
Hayka added, “We are continuing to refine the proprietary Octava technology to increase its specificity and sensitivity. We also are applying our unique technology to develop the Octava BlueTM test that can non-invasively detect false positive mammography results and reduce the number of unneeded biopsies by at least 50%, saving many women the anxiety and discomfort of the biopsy procedure while reducing costs to the health system as a whole.”
The Octava Pink test requires only a small sample of patient plasma to rapidly and cost-effectively determine disease status. It uses proprietary algorithms developed by EventusDx scientists to assess disease-specific autoantibody status. EventusDx will analyze the Octava Pink tests at its ISO-certified laboratory in Israel using a microarray-based approach.
Breast cancer is by far the most common cancer in women worldwide, with an estimated 1.6 million new cases diagnosed in 2010. Breast cancer incidence has been increasing in economically developed regions for many years, with the highest incidence of 89.7 cases per 100,000 women reported in Western Europe. The NCI 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.
The CE mark designation allows product commercialization of the Octava Pink breast cancer test in Europe and other markets.