BCAL Diagnostics’ (ASX: BDX) development and clinical services laboratory in North Ryde, NSW, has received formal accreditation from the National Association of Testing Authorities Australia (NATA).
BCAL’s laboratory meets the NATA, ISO15189 and National Pathology Accreditation and Advisory Council (NPAAC) standards. NATA accreditation was awarded for the laboratory’s quality systems. This achievement represents another pivotal step on the pathway to BCAL’s planned commercialisation of BREASTEST.
“NATA accreditation sends a very positive message to the medical community and women in Australia that our quality systems and processes meet the highest standards as outlined by NATA and NPAAC. 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,” CEO, Shane Ryan, said.
“BCAL is now finalising the necessary analytical and clinical validation of BREASTES, and once validation is successfully completed, BCAL will ask NATA to add BREASTEST to its scope of tests able to be performed at BCAL’s NATA-accredited laboratory. The first phase of BREASTEST commercial launch is in partnership with the Sydney Breast Clinic.”
As planned, BREASTEST will be offered as an adjunct to mammography.
Over the past decade BCAL has developed a blood test for the detection of breast cancer. The test is initially designed to complement current imaging technologies, such as the mammogram, with the aim of becoming a monitoring and screening tool suitable for women of all ages and backgrounds in any location.
With more than two million new cases of breast cancer diagnosed globally each year, a substantial opportunity exists for BCAL to improve patient outcomes.