The Sydney-based company has received accreditation for their development and clinical services laboratory and processes.
BCAL Diagnostics, a company dedicated to the accurate diagnosis of breast cancer, has today announced that its development and clinical services laboratory in North Ryde, Sydney has received formal accreditation from the National Association of Testing Authorities of Australia (NATA).
CEO Shane Ryan said the accreditation sent a positive message to the medical community that BCAL’s systems and processes met the highest national and international standards.
“The laboratory is now ISO 15189 certified, which is an international standard for clinical laboratories and certifies that the laboratory quality systems, documentation and protocols meet the international and Australian standards,” Mr Ryan said.
Executive Chair Jayne Shaw described the achievement as a key step in having the company’s BREASTEST technology, an adjunct to mammography, commercialised.
“With NATA accreditation now secured, BCAL is closer to introducing our cutting-edge technology that will empower clinicians and women, leading to better health outcomes across the country, and ensure that women have access to high-quality breast cancer screening methods,” Ms Shaw said in a statement.
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BREASTEST, which BCAL describes as “a first-of-its-kind blood test designed to complement mammography”, is based on tracking changes in the lipid composition of women who develop breast cancer. The company claims to have identified and confirmed more than 20 key lipids that form part of the breast cancer signature.
BCAL currently finalising the analytical and clinical validation of BREASTEST and will approach NATA to include the test within the BCAL laboratory once validation is complete.
