80.3% sensitivity supports BCAL November launch target for BREASTESTplus 2

BREASTESTplus 2 moves towards November launch

BCAL Diagnostics Limited (ASX:BDX) has cleared a significant product-development hurdle, completing clinical validation of BREASTESTplus 2 for women aged 30 and over across all breast densities. The company reported sensitivity of 80.3% and specificity of 48.5% for early-stage breast cancer, covering Stage 0 ductal carcinoma in situ, Stage 1 and Stage 2 disease.

The result supports a targeted November 2026 launch in Sydney, Melbourne and Brisbane, although BCAL said accreditation and operational readiness work must still be completed. The test is intended to provide additional information alongside imaging and other diagnostic pathways, not to diagnose breast cancer independently or replace mammography. An elevated result requires further investigation and routine clinical management remains with treating clinicians.

Patients accessing the test through participating sites will be offered the opportunity to join the BREASTEST Registry, which BCAL says will support the development of real-world evidence. The validation figures come from the company’s study and should not be read as a measure of performance across all future clinical use.

Avantect rollout adds a second commercial test track

BCAL is also moving from product introduction to access and distribution. Avantect Multicancer is now available at selected Sydney and Melbourne locations, following the phased Avantect rollout reported in September, with preparations underway for national availability through Sonic Healthcare and Healius.

The blood test looks for cancer-associated signals across eight cancer types and provides a likely organ-of-origin signal when one is detected. In ClearNote Health’s case-control validation study, it recorded overall sensitivity of 56.2% and specificity of 98.4% across all cancers and stages analysed. A result showing no signal does not exclude cancer, and the test is positioned as a complement to established screening and clinically recommended investigations.

Revenue remains modest against development spending

Commercial traction is still at an early stage. BCAL reported 29 tests during the quarter across Avantect Pancreatic and BREASTESTplus, generating quarterly revenue of $30,800. Against that, net operating cash outflows reached $1.895 million, including $1.236 million of research and development spending.

BCAL held $580,000 in cash at 30 September and had $2.4 million remaining under its $10 million convertible note facility. The company calculated total available funding of $2.98 million, equivalent to an estimated 1.6 quarters at the reported operating cash-outflow rate. The notes carry a 10% interest rate, are unsecured but supported by a negative pledge, and mature 24 months after the initial issue in December 2025.

That funding snapshot does not include the $2.237 million R&D tax offset received on 9 October. BCAL said it repaid $1.397 million of funding after receiving the offset, expects expenditure to fall and revenue to build, and believes available cash reserves, facilities and the tax receipt support continued operations. The gap between those expectations and actual test volumes will become increasingly important as the company moves into launch mode.

Genetic Signatures stake rises as merger concerns remain

BCAL spent a further $1.5 million acquiring 18.75 million Genetic Signatures Limited (ASX:GSS) shares at 8 cents each, lifting its holding to 41,923,644 shares, or approximately 18.46%. The increase builds on the earlier Genetic Signatures stake, which BCAL describes as exposure to a complementary molecular diagnostics business focused on infectious disease.

At a Genetic Signatures extraordinary general meeting on 28 October, BCAL’s proposed board changes produced a mixed result: former Genetic Signatures chief executive Dr John Melki was appointed, while the proposed appointment of Susan Forrester and the proposed removal of Michael Aicher and Jenny Harry did not pass. BCAL said it welcomed Dr Melki’s appointment but maintained concerns about Genetic Signatures’ proposed merger with Microba Life Sciences Limited (ASX:MAP), which remains subject to separate approvals and conditions.

Commercial execution becomes the next test

Alongside the product launches, BCAL is rebuilding EarlyDetection.com.au, updating referral pathways and refreshing educational material for GPs, specialists and telehealth users. Michelle Blackwell joined as Chief Product Innovation Officer in August, with responsibility for product innovation, commercial activities and translating research into diagnostic services.

The near-term milestones are unusually concrete for a development-stage diagnostics company: finish BREASTESTplus 2 accreditation, begin the targeted November launch, convert expanded access into test volumes and progress Avantect towards national availability. Whether those steps can narrow the distance between a growing portfolio and a 1.6-quarter reported funding runway remains the central question.