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.