BCAL Diagnostics (ASX: BDX) is on track to launch the cutting-edge Avantect pancreatic and ovarian cancer tests onto the Australian market in the new year.
BCAL will distribute the simple DNA-based blood tests – developed by US-based company ClearNote Health – under an exclusive licence agreement secured in September that gives BCAL the rights to distribute and commercialise the tests in Australia and New Zealand, and covers all future tests based on ClearNote’s proprietary epigenomics testing platform.
The ovarian test will initially be offered to women with familial or genetic risk, including BRCA mutation carriers and those with strong family histories of breast or ovarian cancer.
Clinical Improvements
Ahead of the Australian launch, BCAL confirmed that updated clinical performance data had demonstrated major improvements in early-stage detection across both Avantect tests.
The pancreatic test showed high sensitivity and improved specificity at Stage 1 and Stage 2 (where no reliable blood-based diagnostic currently exists), as well as strong performance in patients presenting with non-specific abdominal, gastrointestinal, or metabolic symptoms.
In a validation cohort of 1,445 tests, sensitivity of the test was 82.6% at a specificity of 97.5%.
The pancreatic test could potentially be used for surveillance of patients with Type 2 diabetes, who are at an increased risk of developing pancreatic cancer in the first three years following diagnosis.
Australia records over 20,000 new Type 2 diabetes diagnoses each year, adding a population of around 60,000 to those with a known familial or genetic risk.
UK Pancreatic Study
The Avantect pancreatic test is currently being evaluated in a UK study of 15,000 new-onset Type 2 diabetes patients, with the results expected to demonstrate the clinical merits of semi-annual testing for this population.
The test has also been evaluated for its potential to detect pancreatic ductal adenocarcinoma in high-risk individuals enrolled in the international Pancreatic Cancer Early Detection (PRECEDE) study.
Interim results have shown a real-world performance that exceeds the validated performance and demonstrated potential of the test for surveillance in high-risk populations.
Suite of Diagnostic Tests
BCAL chief executive officer Shane Ryan said the ClearNote partnership would be “transformative” for the company, and that the Australian medical community would benefit from a suite of diagnostic tests that will materially improve patient outcomes.
“ClearNote’s recent global achievements — including UK regulatory approval of a priority fast-track submission for pancreatic cancer — significantly strengthen the commercial outlook for the Avantect portfolio, and provide momentum for our Australian launch in January,” he said.
BCAL has also enhanced the clinical application of its ++BREASTEST plus++ first-in-class blood test for use alongside standard mammograms in breast cancer screening, with recent data analysis enabling the expansion of clinical coverage from patients with Class D breast density who do not have breast cancer to a broader group of women being evaluated for the disease.
BREASTEST plus is currently available across Sydney and Melbourne and plans are underway to expand availability to Brisbane, providing greater access for more doctors and patients.
“With BREASTEST plus building clinical traction, and the Avantect tests preparing for domestic launch, we are well-positioned to become an Australian leader in early cancer detection,” Mr Ryan said.
