BlinkLab (ASX:BB1) Expects to Finish its Dx1 Autism Diagnostic Pivotal Study

Aditi Sarkar

29 October 2026 03:58 PM AEDT

BlinkLab (ASX:BB1) Expects to Finish its Dx1 Autism Diagnostic Pivotal Study

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BlinkLab (ASX:BB1) Limited, an AI-powered digital healthcare diagnostics company, said in its quarterly report for the period ended 30 September 2026 that its pivotal study for the Dx1 autism diagnostic is expected to finish in the fourth quarter of calendar 2026. The company plans to submit the results to the US Food and Drug Administration (FDA) in the first quarter of 2027 under a 510(k) pathway, and expects an FDA response in the second quarter of 2027.

Dx1 pivotal study

BlinkLab said the FDA clearance threshold for Dx1 is sensitivity and specificity above 65%. An earlier US pilot study in 485 children reported 84% sensitivity and 85% specificity. The company also plans to pursue CE/MDR clearance in Europe. It said the University of Pennsylvania and University of Arkansas sites left the pivotal study and were replaced by Indiana University School of Medicine. Clearance is not assured, and the company said Dx1 still needs FDA approval before any US launch.

Dx2 ADHD programme

BlinkLab also reported results for Dx2, its ADHD test. A study of 208 children aged 6 to 17, comprising 117 with ADHD and 91 controls, showed 82% sensitivity and 83% specificity. The company described this as an exploratory study that was not designed for regulatory submission and said the results need further prospective validation. A pre-FDA pilot for Dx2 is planned to begin in the second quarter of 2027, with completion expected in the second half of that year, followed by a pivotal study and FDA submission in 2028, subject to regulatory engagement.

Other research and commercial steps

BlinkLab said it has nine exploratory research programmes, with four readouts expected in the fourth quarter of 2026 and five in 2027. A nationwide, government-funded autism screening programme in Morocco launched on 22 October 2026. The company said it has no revenue yet, that the planned US launch depends on regulatory clearance, and that pivotal study sites are expected to be the first customers.

On the board, Dr Raphael Bernier joined as a non-executive director and Dr Richard Hopkins stepped down.

Cash and funding

Cash at 30 September 2026 was A$16.2m (A$16,211,000), down from A$17.95m at the end of the previous quarter. Operating cash outflow was A$1.802m, made up mainly of research and development spending of A$1.330m and administration and corporate costs of A$0.500m. Investing outflow was A$0.336m, and financing inflow was A$0.400m, mainly from option exercises. Related-party payments of A$0.208m covered director fees and superannuation. The company estimates about nine quarters of funding at its current operating burn and reports no undrawn facilities.

Milestones and risks

The company's timetable runs through the next year: completion of the Dx1 pivotal study in the fourth quarter of 2026, submission of results to the FDA and a CE/MDR application in the first quarter of 2027, an expected FDA response in the second quarter, and the start of the Dx2 US pilot in the same quarter.

Key risks identified in the report include regulatory outcomes for both products, the need for further validation of the ADHD results, the change of pivotal study sites, and the absence of revenue. Until the pivotal study data are submitted and reviewed, the commercial plan for the United States remains conditional on regulatory clearance, and the Moroccan screening programme is the only live deployment referred to in the report.

Investors should note that the pivotal study readout is the first point at which the company's own clearance threshold can be compared with prospective data collected across the replacement sites. The company's runway estimate of about nine quarters is based on current operating burn, and its cash balance fell by about A$1.7m over the quarter, reflecting ongoing research and development spending with no product revenue yet recorded.

FAQs

Q: What did BlinkLab report?

A: BlinkLab said in its September 2026 quarterly report that it plans to submit Dx1 pivotal data to the US regulator in early 2027, with cash of A$16.2m and no revenue yet.

Q: What developments are outlined in the update?

A: Investors should note that the pivotal study readout is the first point at which the company's own clearance threshold can be compared with prospective data collected across the replacement sites. The company's runway estimate of about nine quarters is based on current operating burn, and its cash balance fell by about A$1.7m over the quarter, reflecting.

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