Australian-based BCAL Diagnostics opens its development and clinical service laboratory in Sydney, marking 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.
“BCAL is diligently working toward bringing its novel diagnostic tool to women and the opening of our soon to be fully commercial and accredited laboratory brings us one step closer to accomplishing this goal,” said Jayne Shaw, Executive Chair of BCAL Diagnostics. “We plan to use this laboratory for a variety of purposes leading up to and following product approval and availability. We are very excited by the market access opportunities that this laboratory provides, not only for current and future tests that may be developed by BCAL, but also for those developed by other companies seeking entry to the Australian market.”
The Company continues to make significant clinical development progress and has conducted multiple studies with more than 1,200 patients. Studies have shown changes to specific lipids in the presence of breast cancer. A poster titled Lipodomic signature from plasma to detect localised breast cancer will be presented during the 2023 ASCO Annual Meeting, June 2-6, 2023 in Chicago.