ITSI – Bioscience has announced the receipt of a $100,000 Small Business Innovation Research (SBIR) Phase 1 grant from the National Cancer Institute. The grant will support ITSIBIO’s ongoing blood-based breast cancer detection biomarker program that promises to provide an alternate method for earlier detection and accurate classification of breast malignancies.

At the moment mammography is the most widely used screening tool for breast disease detection and diagnosis. Unfortunately, mammography can miss some breast cancers, especially in young women with dense breast, it cannot unequivocally distinguish between benign and malignant lesions and it can not be performed remotely. If successfully validated, the proposed blood test would be beneficial to all women who show abnormalities in their mammograms and require further testing. Most of these women currently endure biopsies, up to 80% of which are probably unnecessary, as no cancer is found.

According to Richard Somiari, PhD principal investigator for the study titled “development of a blood test for breast cancer detection” the grant will support a) the collection of blood samples from informed and consented female donors, b) multiplexed assay development using a suspended array technology and c) development of a prototype breast disease classification model. While there are other efforts around the world to develop biomarker based tests for breast disease detection and classification the “ITSIBIO blood test is unique in its approach, because, it could allow accurate classification of breast disease and employ a reliable and sensitive blood RNA detection method that does not require RNA isolation and polymerase chain reaction” added Dr Somiari.