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%.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
You may be eligible if
Female subjects 18 years or over.
Subjects following a mammography test.
Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.
You may not be if
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
Clareo Health | Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
