Blood Test Confirms Negative Mammography, Detects Missed Cancer

A rapid, accurate, and cost-effective blood test measures disease-specific autoantibodies to detect the presence of breast cancer.

The Octava Pink breast cancer test is produced by Eventus Diagnostics (EventusDx, Miami, FL, USA; Ora, Israel). The company plans to commercialize its products in collaboration with corporate partners in the US, Europe, and Asia. Octava Pink is intended for confirmatory use in women who have received negative mammography results. The National Cancer Institute (NCI; Frederick, MD, USA) 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 accurately confirms true negative mammography results, 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.

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 US.

“We developed Octava Pink to address a serious shortcoming of mammography—the high rate of false negative results,” said Prof. Benjamin Piura, MD, FRCOG, CMO of EventusDx 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 multisite 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.”

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.

EventusDx has received the CE mark designation for the Octava Pink breast cancer test. “Receiving CE marking for Octava Pink is an important milestone for our company,” said Alon Hayka, president of EventusDx 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 Blue test that can noninvasively 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.”

Eventually EventusDx intends to apply its technology to develop blood tests for the detection of additional cancers, including lung, colon, prostate, and ovarian cancers. The company plans to commercialize its products in collaboration with corporate partners in the US, Europe, and Asia.

Related Links:
Eventus Diagnostics
The National Cancer Institute