BCAL Diagnostics Ltd (ASX:BDX) has reported further clinical, regulatory and commercial progress across its early cancer detection portfolio, ahead of the planned Australian launch of its blood-based pancreatic and ovarian cancer tests in January 2026.
Through its exclusive licence with US-based ClearNote Health Inc., BCAL intends to introduce the Avantect® Pancreatic and Avantect® Ovarian blood tests into the Australian market from January 2026.
ClearNote has continued to build international validation for its epigenomic platform, with updated clinical data showing improved early-stage detection performance for both Avantect® Pancreatic and Avantect® Ovarian tests.
“Our partnership with ClearNote Health is transformative as it expands our portfolio into the early detection of multiple cancers. The Australian medical community will benefit from a suite of early diagnostic tests that will materially improve outcomes for patients,” BCAL CEO Shane Ryan said.
“ClearNote’s recent global achievements, including UK regulatory approval, selection for the US Vanguard Trial, advances in US reimbursement, and the priority Fast-Track submission for pancreatic cancer, significantly strengthen the commercial outlook for the Avantect® portfolio. These milestones provide momentum for the Australian launch of Avantect® in January 2026."
Avantect® pancreatic and ovarian tests progressing to Australian launch
The Avantect® Ovarian test will initially be offered to women with familial or genetic risk factors, including BRCA mutation carriers and those with a strong family history of breast or ovarian cancer.
For pancreatic cancer, the Avantect® test has shown high sensitivity and improved specificity at Stages I–II, where there is currently no reliable blood-based diagnostic. In a validation cohort of 1,445 tests, the assay reported sensitivity of 82.6% at a specificity of 97.5%. The test has also demonstrated strong performance in patients presenting with non-specific abdominal, gastrointestinal or metabolic symptoms.
A key target population is patients recently diagnosed with type 2 diabetes, where pancreatic cancer is 6–8 times more common in the first three years post-diagnosis compared with the general population. In Australia, more than 20,000 new type 2 diabetes diagnoses are recorded annually, creating a surveillance pool of around 60,000 people, in addition to those with known familial or genetic risk of pancreatic cancer.
The Avantect® Pancreatic test is being evaluated in the 15,000-participant SAFE-D trial in the UK, focused on new-onset type 2 diabetes patients, with results expected to inform the role of semi-annual testing in this group. In a separate study within the Pancreatic Cancer Early Detection (PRECEDE) Consortium, interim real-world data across 612 samples showed performance exceeding previous validation results, supporting use of Avantect® Pancreatic for surveillance in high-risk individuals.
BCAL estimates these two core applications represent an addressable market of more than $250 million per annum in Australia for the pancreatic test alone.
A health economic analysis conducted with the Mayo Clinic and the Arizona Centers for Digestive Health, and presented at the ISPOR conference in Barcelona in November 2024, found that monitoring newly diagnosed type 2 diabetes patients aged 50 and over with Avantect® is cost-effective and has potential to improve survival outcomes.
In Australia, BCAL is working with the Pancare Foundation, which supports patients and families affected by upper GI cancers including pancreatic cancer, to increase community awareness of early detection benefits. The company is also collaborating with Professor Jaswinder Samra, a leading pancreatic and hepatobiliary surgeon at Royal North Shore Hospital and Macquarie University Hospital, to develop local clinical pathways.
Commenting on the emerging data, Professor Samra said epigenomic blood testing “represents one of the most promising advances for pancreatic cancer in decades,” noting that detecting disease while still operable could materially improve survival prospects for patients who are currently often diagnosed too late for curative treatment.
ClearNote strengthens global platform and reimbursement position
ClearNote’s epigenomic platform has been selected for inclusion in the US Vanguard Trial, one of the largest federally supported multi-cancer early detection studies, providing additional large-scale independent validation ahead of the Australian roll-out.
The company has also advanced towards payer reimbursement in the United States, including acceptance of clinical data packages, reimbursement agreements with major US insurers and submission of a priority fast-track application for Avantect® Pancreatic under an expedited US regulatory review pathway.
In the UK, ClearNote has obtained regulatory approval for the Avantect® testing platform, enabling clinical deployment across that market.
BREASTESTplus™ broadens clinical reach
BCAL has also reported a clinical and commercial update on its BREASTESTplus™ breast cancer rule-out test, which is used alongside standard mammography.
BREASTESTplus™ was initially launched in 2025 for women with extremely dense breast tissue (density class D) to help rule out breast cancer. Following completion of a clinical study of 613 Australian women with high breast density, the test now demonstrates 90% sensitivity with a projected negative predictive value of 99.7%, and can be used in women with either C or D breast density.
“We continue to make strides in expanding the reach of BREASTESTplus with new data confirming significant expansion in addressable market. With BREASTESTplus building clinical traction, and the Avantect® tests preparing for domestic launch, BCAL is well positioned to become an Australian leader in early cancer detection,” Ryan said.
This expanded coverage is expected to extend applicability to around 50% of women undergoing screening for breast disease.
BREASTESTplus™ is currently available across Sydney and at one Melbourne site. BCAL plans to increase availability in Melbourne and to start roll-out in Brisbane to broaden access for clinicians and patients.
Telehealth pathway for early detection
To support uptake and patient access, BCAL intends to launch a dedicated telehealth service in Q1 2026, connecting interested individuals with qualified clinicians for early detection consultations.
Individuals can register for updates and further information via www.bcaldiagnostics.com or at earlydetection.com.au.