FDA Grants 510(k) Clearance to Ibex Prostate Detect AI for Prostate Cancer
The FDA cleared Ibex Prostate Detect, an artificial intelligence tool aiding prostate cancer detection.
- The FDA has granted a 510(k) clearance to the Ibex Prostate Detect software (formerly Galen Second Read).
- The Ibex Prostate Detect software is an in vitro artificial intelligence (AI)-powered digital pathology solution that aids in identifying small and rare prostatic cancers via tissue biopsies.
- This FDA clearance marks the first regulatory clearance for Ibex Medical Analytics.
The FDA has granted 510(k) clearance to Ibex Prostate Detect, an AI-powered digital pathology solution designed to assist in detecting small and rare prostate cancers in tissue biopsies.1
Ibex Prostate Detect uses AI to analyze whole slide images of prostate core needle biopsies stained with hematoxylin and eosin. The software generates heat maps that highlight areas of potential malignancy, alerting pathologists at both the case and slide levels to suspicious regions that may have been overlooked during the initial assessment.
Validation studies that demonstrated a positive predictive value of 99.6% for heat map accuracy support this FDA clearance. Additionally, the AI system was able to identify 13% of prostate cancer cases that had been missed by pathologists during initial diagnoses—cases that were subsequently confirmed upon review.
"Prostate cancer is one of the most prevalent cancers worldwide, with an estimated 1 in 8 men diagnosed in their lifetime,” said Mahul B. Amin, MD, Ibex scientific advisor, vice president, and medical director of Labcorp’s Hospital Systems Operating Division and clinical professor of pathology and laboratory medicine at the University of Tennessee Health Science Center, in the press release.1 “With the global incidence expected to double by 2040, accurate and timely diagnoses are more critical than ever. Advancements in AI-powered pathology can support pathologists in delivering precise and efficient diagnoses, ultimately improving patient outcomes.”
3D rendered medically accurate illustration of prostate cancer: © SciePro - stock.adobe.com
A pivotal study published in Lancet Digital Health evaluated the AI system’s performance in prostate cancer detection.2 The results demonstrated an AUC of 0.991 (0.979-1.00) for identifying prostate cancer in an external validation set, an AUC of 0.957 (0.930-0.985) for detecting perineural invasion, an AUC of 0.941 (0.905-0.977) for distinguishing between low-grade (Gleason 6) and high-grade (Gleason 7-10) tumors, and an AUC of 0.971 (0.943-0.998) for detecting Gleason pattern 5 tumors.
The AI tool also triggered 560 cancer alerts, leading to additional histologic evaluation in 9% (n = 51) of cases through further cuts or stains.
This FDA clearance marks the first regulatory clearance for Ibex Medical Analytics. Ibex’s AI platform extends beyond prostate cancer, with solutions also developed for breast and gastric cancer diagnostics.
“The FDA clearance marks a significant milestone in Ibex’s journey and exemplifies our dedication to developing clinically validated solutions that help improve patient health outcomes,” said Joseph Mossel, chief executive officer at Ibex Medical Analytics, in the press release.1 “This clearance affirms our commitment to the safety and efficacy of our AI solutions and strengthens our ability to provide cutting-edge innovation to pathologists, which ultimately benefit patients. We hope this accomplishment will bolster industry-wide confidence that AI-powered digital pathology is ready for widespread clinical adoption.”
