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RevealDx’s precision medicine software for lung nodule risk analysis receives regulatory clearance in Australia and New Zealand

Volpara Health – Published on September 21, 2022

Strategic partner Volpara Health to distribute RevealAI-Lung™ in Australia and New Zealand

Wellington, NZ, 21 September 2022: RevealDx and Volpara Health (ASX: VHT) today announced that RevealAI-Lung™, an AI-powered software application that helps accelerate lung cancer diagnosis and reduce unnecessary procedures, has received Therapeutic Goods Administration (TGA) clearance from the Australian Government Department of Health. RevealAI-Lung will be sold in Australia and New Zealand by Volpara Health.

Lung cancer is the leading cause of death among men and women worldwide. In 2021, 8,693 Australians lost their lives to lung cancer—almost one person every hour. Australians are commonly diagnosed late, 42 percent receiving their diagnosis as stage IV (the most advanced), when their likelihood of surviving five years is less than 5 percent. The economic burden of lung cancer in Australia could inflate to $8.5 billion by 2031.1

Early diagnosis of lung cancer relies on effective triage of small lesions called nodules. Most nodules are benign, but the pathway to obtaining a diagnosis is expensive and slow and may involve a follow-up CT or a surgical biopsy.

Reveal AI-Lung can help clinicians identify nodules at high or low risk levels when found as part of a lung cancer screening program or incidentally when performing Chest CT for other reasons.

“Volpara is driven to make cancer screening programs more successful, efficient and cost effective,” said Teri Thomas, CEO of Volpara. “Adoption of Reveal-AI-Lung in Australia will help reduce false positives reduce cost and improve clinical decision-making for better patient outcomes.”

Reveal AI-Lung uses radiomics and artificial intelligence to score nodules of interest on a malignancy similarity index (mSI). This precise, automated analysis of each lung nodule and score can inform clinical decision-making to drive the optimal clinical pathway for each patient.

Early clinical data for RevealAI-Lung suggests that many cancers can be detected earlier by using the AI nodule analysis, while simultaneously reducing false positives and bearing potentially significant cost savings. Researchers who applied the RevealAI-Lung CADx solution to chest CTs from 963 patients with 1,331 nodules found that RevealAI-Lung combined with Lung-RADS could significantly improve lung nodule severity assessment in sensitivity and specificity. Results included a 29-33% reduction of false positives in the screening cohorts, which could lead to diagnosis a year earlier in 42% of cancer patients.2

“Working with Volpara to put precision medicine tools in the hands of radiologists can be a game changer in lung screening programmes in Australia and New Zealand,” said Chris Wood, RevealDx CEO. “Enhancing interpretation with nodule analysis has the potential to detect malignancies more accurately and quickly, ultimately saving more lives from lung cancer.”

RevealAI-Lung integrates with a provider’s picture archiving and communication system (PACS) and results are displayed within a few seconds. The technology works with any vendor’s CT and all commonly used reconstruction techniques. It has been validated on population-level studies that included a variety of vendor hardware and software, and included nodules found as part of a screening exam and nodules that were found incidentally.2

About RevealDx
RevealDx is a Seattle-based software company whose vision is to dramatically improve lung cancer outcomes. RevealDx achieves this by delivering the most advanced, radiomics- and AI-enabled, lung cancer decision-support software, driving the optimal clinical pathway for each patient.

For more information, visit:

About Volpara Health Technologies Limited (ASX:VHT)
Volpara Health Technologies makes software to save families from cancer. Healthcare providers use Volpara to better understand cancer risk, empower patients in personal care decisions, and guide recommendations about additional imaging, genetic testing, and other interventions. Our AI-powered image analysis enables radiologists to quantify breast tissue with precision and helps technologists produce mammograms with optimal image quality, positioning, compression, and dose. In an industry facing increasing staffing shortages, our software streamlines operations and provides key performance insights that support continuous quality improvement.

Volpara is the preferred partner of leading healthcare institutions around the world. Our software is used in over 2,000 facilities by more than 5,000 technologists, impacting nearly 15 million patients globally. It helps providers conduct more than three million cancer risk assessments each year and can be deployed stand-alone or fully integrated with electronic health record systems, mammography reporting systems, imaging hardware, and genetic laboratories. Volpara holds the most rigorous security certifications and numerous patents and regulatory registrations, including FDA clearance and CE marking. Since listing on the ASX in April 2016, the Company has raised A$132 million. With offices in Seattle and Boston, Volpara is based in Wellington, New Zealand.

For more information, visit:

1 Lung Foundation Australia. The Next Breath: Accelerating Lung Cancer Reform in Australia 2022-2025. Second National Blueprint for Action on Lung Cancer.

2 Adams SJ, Madtes DK, Burbridge B, Johnston J, Goldberg IG, Siegel EL, Babyn P, Nair VS, Calhoun ME, Clinical impact and generalizability of a computer-assisted diagnostic tool to risk-stratify lung nodules with computed tomography, Journal of the American College of Radiology (2022), doi: