blood test for breast cancer associated auto antibodies - improvement of octava blood test

Conditions: Breast Cancer

Summary: 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%.

Eligibility criteria:
inclusion criteria: * female subjects 18 years or over. * subjects following a mammography test. * subject with pathological evaluation after mammography with birads 3-4-5-6. exclusion criteria: * female subjects less than 18 years of age * previous or concurrent malignancies * autoimmune disorders diagnosed subjects * hematological malignancies * subjects under active chemotherapy treatment or chemotherapy in the past 6 months * steroid treatment in the past 3 months * subject undergoing immunosuppressive treatments * subject with verified breast cancer other than invasive ductal or invasive lobular as verified by biopsy/cytology

Keywords: breast cancer cancer associated auto antibodies breast cancer blood test