BCAL Diagnostics has begun introducing ClearNote Health’s Avantect Multi-Cancer blood test in Australia, starting with Sydney and Melbourne. The test reported 56.2% sensitivity and 98.4% specificity in a case-control validation study, but the company says a negative result does not rule out cancer.
- Phased Sydney and Melbourne launch
- Blood test covers eight cancers
- 56.2% overall sensitivity and 98.4% specificity
- Samples initially analysed in the United States
- BCAL’s early detection portfolio expands to four tests
Eight-cancer test enters Australian market
BCAL Diagnostics Limited (ASX:BDX) has started a phased Australian rollout of Avantect Multi-Cancer, adding a blood-based test spanning eight cancers to its commercial early detection portfolio. The initial launch covers Sydney and Melbourne, with telehealth and in-person consultations available through BCAL’s clinical and referral networks.
Avantect Multi-Cancer looks for cancer-associated signals in blood and provides a likely organ-of-origin signal when one is detected. The test covers lung, pancreatic, liver, ovarian, gastric, oesophageal, breast and colorectal cancers, giving BCAL a broader product than its cancer-specific Avantect Ovarian and Avantect Pancreatic services.
Validation results come with an important limitation
In ClearNote Health’s case-control validation study, the test recorded overall sensitivity of 56.2% and specificity of 98.4% across all analysed cancers. The figures combine all cancer stages and the cancers assessed in the study, rather than representing performance in a single disease or stage.
That distinction matters. BCAL states that the study used non-cancer controls and that a 56.2% sensitivity means a result showing no signal does not exclude cancer. Avantect Multi-Cancer is positioned as a complement to established screening programs and other clinically recommended investigations, not as a standalone diagnostic.
US laboratory supports the first rollout
Australian patient samples will initially be processed at ClearNote Health’s CLIA-certified and CAP-accredited laboratory in the United States. BCAL says it is working to bring analysis of its full portfolio into its commercial clinical laboratory in Sydney, but has not provided a timetable for that transition.
The phased approach is intended to build experience with clinician engagement, patient demand, service delivery, pricing and access pathways before a broader national expansion. The announcement does not disclose pricing, reimbursement arrangements, expected patient volumes or revenue targets, leaving the commercial scale of the launch untested.
BCAL CEO Anne-Louise Arnett said the test expands the company’s commercial portfolio and creates an opportunity to use its existing national infrastructure to build a broader early detection business. The portfolio now includes BREASTESTplus, Avantect Ovarian, Avantect Pancreatic and Avantect Multi-Cancer.
Bottom Line?
The launch broadens BCAL’s addressable testing offering, but its investment case will increasingly depend on real-world uptake, clinical adoption and evidence beyond a case-control study.
Questions in the middle?
- How quickly will Sydney and Melbourne generate clinician referrals and patient demand?
- What pricing and reimbursement pathways will determine access beyond the initial rollout?
- Will real-world and stage-specific evidence support wider clinical use of the test?