BCAL Diagnostics Limited Announces Establishment of Development & Clinical Service Laboratory
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.