Quibim, a global pioneer in imaging biomarkers for precision medicine, announced that its QP-Prostate CAD solution has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for prostate cancer lesion detection and diagnosis. This regulatory milestone enables the company to enter the U.S. healthcare market with its AI-powered technology that has already been implemented across Europe, the UK, and Australia.
The FDA clearance follows successful validation studies, including a multi-reader, multi-case study conducted by Massachusetts General Brigham (MGB) Data Science Office in collaboration with University Hospitals Ohio. The study demonstrated that QP-Prostate met both its primary endpoint of area under the receiving operating curve (AUROC) using biopsy as ground truth and its superiority endpoint of aided radiological performance versus unaided interpretation.
Addressing a Growing Healthcare Challenge
With prostate cancer affecting one in eight men during their lifetime, radiology departments worldwide face mounting pressure to manage the increasing volume of prostate MRI scans required for proper diagnosis prior to biopsy. QP-Prostate aims to address this challenge by leveraging artificial intelligence to enhance diagnostic workflows.
The system provides several key capabilities:
- Accelerated image processing
- Improved radiologist accuracy in cancer detection
- 3D visualization of the prostate gland and lesions
- Risk stratification for identified lesions
- Support for early diagnosis and timely treatment decisions
Dr. Angel Alberich-Bayarri, CEO and Founder of Quibim, emphasized the significance of this achievement: "We are excited to receive FDA 510(k) clearance for our QP-Prostate's lesion detection and diagnosis capability. This validates our technology's efficacy and strengthens our commitment to improving prostate cancer diagnostics globally."
Clinical Impact and Market Positioning
The QP-Prostate system has already been adopted by leading medical institutions across Europe, including Hospices Civils de Lyon – CHU de Lyon, Hospital Universitario Ramón y Cajal, Hospital Universitario Nuestra Sra. del Rosario, and Hospital Universitario de La Ribera.
"Integrating AI technology into prostate MRI enhances diagnostic precision in identifying clinically significant prostate cancer," Dr. Alberich-Bayarri explained. "It minimizes the need for unnecessary biopsies by improving scan specificity and streamlining workflows by automating tasks like prostate volume and lesion segmentation, ultimately benefiting patients with more efficient and accurate care."
The company sees significant potential in the growing markets for fusion biopsy and focal therapy, areas where QP-Prostate is well-positioned to provide support.
Technical Differentiation
A key differentiator of QP-Prostate is its use of actual pathology data as ground truth for algorithm training. David Bazaga, VP of Product at Quibim, highlighted this approach: "The use of pathology data to train and validate our algorithm has been pivotal, and we're eager to see the real-world impact it will have in the future."
The system's designation as both a Computer-Aided Detection (CADe) and Computer-Aided Diagnosis (CADx) tool reflects its comprehensive capabilities in the prostate cancer diagnostic pathway.
Expanding Portfolio
QP-Prostate is part of Quibim's growing portfolio of AI-powered medical imaging solutions, which also includes:
- QP-Brain for quantification and visualization of neurological imaging findings
- QP-Insights, a web platform for managing and analyzing medical images and clinical data
- QP-Liver for diagnosing diffuse liver diseases through quantification of tissue fat and iron from MRI scans
The company has also established strategic partnerships with industry leaders, including Merck KGaA for developing imaging biomarker models to predict cancer patient responses to immunotherapy, and Phillips to launch AI-based imaging and reporting solutions for MR prostate exams.
With offices in New York, Cambridge (UK), Valencia, Madrid, and Barcelona, Quibim continues to expand its global footprint in the medical imaging AI sector, with more than 170 sites currently using its products worldwide.
