BCAL Diagnostics Limited announced the opening of its development and clinical service laboratory in Sydney. This step marks an important milestone for the company as it advances commercialization of its non-invasive blood screening that is initially intended to be used alongside other breast cancer screening methods, with results to date demonstrating 91% sensitivity and 80% specificity. The technology will initially complement current imaging technologies, such as the mammogram, while BCAL further progresses the development of a monitoring and screening test suitable for women of all ages and backgrounds in any location.

The laboratory will utilize the newest Liquid Chromatography Mass Spectrometry (LCMS) platforms to continue to advance the findings of the Company's clinical research to-date and the progress made by BCAL Diagnostics' US commercialization partner, Precion Inc. to establish and validate workflows, test protocols and algorithms for the BCAL blood screening tool. It will also serve as the testing site for the ongoing and planned clinical validation studies and will establish the quality systems and protocols to be compliant with ISO 15189, CLIA accreditation, NPAAC (National Pathology Accreditation Advisory Council) certifications and requirements of the Therapeutic Goods Act 1989 (Cth). The successful completion of these studies and receipt of the accreditations will allow the BCAL blood screening tool to be available to the medical community and patients as an in-house developed test, also known as a laboratory-developed test or LDT.

Patient samples will be collected and forwarded to BCAL's laboratory, where they will be tested for the proprietary BCAL lipid signature that is expressed by breast cancer cells.