BCAL Diagnostics Limited Announces Establishment of Development & Clinical Service Laboratory
October 24, 2022 at 05:55 pm
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BCAL Diagnostics Limited announced it has entered into a commitment to lease for a Sydney facility that will be the Development and Clinical Services Laboratory for the Company. The founding of this laboratory represents a major step towards the commercialisation of the Company's blood-based test to detect breast cancer. This laboratory will utilise the findings of the Company's clinical studies to date and the outcomes of work being carried out by BCAL's US
commercialisation partner Precion Inc. to establish, validate the workflows, test protocols and algorithms for the BCAL breast cancer test. The laboratory will be the testing site for the ongoing and planned clinical studies and will establish the quality systems and protocols to be compliant with ISO 15189, NPAAC (National Pathology Accreditation Advisory Council) certifications and requirements of the Australian Therapeutics Good Act. These accreditations will allow the BCAL breast cancer blood test to be available to the medical community and patients as an in-house developed test, also known as an LDT. Patient samples will be collected and forwarded to this laboratory where they will be tested for the proprietary BCAL lipid signature that is indicative for breast cancer. BCAL has taken the decision to establish this laboratory as the fastest and most efficient way to establish market access for the BCAL test. As a fully commercial and accredited laboratory, it also provides the opportunity for achieving rapid market access not only for current and future tests that may be developed by BCAL, but also for those developed by other companies seeking
an entry to the Australian market.
BCAL Diagnostics Limited is an Australia-based biotechnology company, which is focused on improving health outcomes for women. The Companyâs principal activities include the development of a novel blood screening test to improve the early diagnosis and monitoring of breast cancer, including preparation for clinical trials. It developed a blood screening test to be used alongside breast cancer screening methods. The technology initially complements imaging technologies, such as the mammogram, while it further progresses the development of a monitoring and screening test suitable for women of all ages and backgrounds in any location. Its BCAL test is a lipid biomarker blood (Breast Cancer Associated Lipids test) test with the potential to be used for breast cancer prevention, screening, and monitoring. The Company has partnered with Precion Inc. to optimize protocols and procedures for the clinical studies required for regulatory approvals across several jurisdictions.