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Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI).

For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI).

MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result.

For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).

Galit Yahalom, PhD.

Sarah Cohen, CRA

Benjamin Taggart, B.S.

Bevers, Prof.

Strano, Prof.

Sklair, Dr.

Tanir Allweis, Dr.

Orit Golan, Dr.

Iacobelli, Dr.

Edith Perez, Prof.

The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.

This is a multicenter, prospective study containing 3 parts:

Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:

Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.

Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.

Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.

Objectives:

(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).

(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.

Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.

Objectives:

(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.

(ii) To estimate the proportion of patients who are positive for the test in the target population

Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.

Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.

OctavaPink for Women With Dense Breast After Negative Mammography

OctavaPink® For Dense Breast After Negative Mammography

Eventus Diagnostics Ltd

Women with negative mammography (BIRADS 1-2), as negative controls.

Women with positive biopsy for (ID, IL, DCIS) as patients.

Women with positive mammography (BIRADS 3-4-5-6), and a negative biopsy diagnosis for breast cancer (ID, IL, DCIS) will be enrolled as benign (ADH, ALH, LCIS, fibroadenoma, fibrocystic changes (including sclerosing adenosis), Benign papillaoma, normal breast) as benigns.

Galit Yahalom, Ph.D

Arie Bitterman, MD

Octava has two versions, each with a different intend of use.

OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized clinical laboratories. The product is used for two following indications:

* Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed mammography and were determined negative for breast cancer. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of mammography false negatives. In addition, being highly specific (\>95% specificity) it supplies additional evidence for true mammography negative result which will reduce examinees anxiety of being misdiagnosed as a result of high false negative mammography rate (10-30%)
* Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed biopsy after positive mammography and the biopsy result was negative. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of biopsy false negatives. In addition being highly specific (\>95% specificity) it supplies an additional evidence for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.

OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx authorized laboratories. Intend of use of OctavBlue is the following:

• OctavBlue is indicated for women above 18 years old, who performed mammography and received doubtful results. Being highly sensitive (\>95% sensitivity) the test can help to reveal 95% of positive cases; and being moderately specific (\>55% specificity) - about half of negative cases. The test is not intended to be used as a standalone diagnostic technique but to supply additional information to a physician and help deciding about the further course of diagnosis.

The primary objectives - To improve the specifications of the OctavaPink test and the OctavaBlue test. The current specifications being

1. For the OctavaPink - 95% specificity and 50% sensitivity.
2. For the OctavaBlue - 50% specificity and 95% sensitivity.

The study will be considered as successful in any of the below options -

1. If the new antigens incorporated in the OctavaPink chip will maintain specificity of at least 95% and increase the sensitivity to at least 85%.
2. If the new antigens incorporated in the OctavaBlue chip will maintain sensitivity of at least 95% and increase the specificity to at least 85%.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OctavaPink for Women With Dense Breast After Negative Mammography	NCT02209389	Breast Cancer	MRI	30 Years - 79 Years	Eventus Diagnostics Ltd
OctavaPink for Women With Dense Breast After Negative Mammography	NCT02209389	Breast Cancer	MRI	30 Years - 79 Years	Eventus Diagnostics Ltd
Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test	NCT02066025	Breast Cancer		18 Years -	Eventus Diagnostics Ltd
Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test	NCT02066025	Breast Cancer		18 Years -	Eventus Diagnostics Ltd

Spots Global Cancer Trial Database for breast cancer blood test