FDA grants clearance to AI-powered prostate cancer management platform

The FDA has granted 510(k) clearance to iQuest, an artificial intelligence (AI)–powered software application program for the management of patients with prostate cancer.¹

“iQuest combines existing patient-specific diagnostic information and deep-learning algorithms to create a tailored [3D] map of where cancer is within the prostate,” Avenda Health, the develop of iQuest, explained in a press release.¹

According to Avenda, iQuest has been validated in multiple clinical studies. For example, clinical data for iQuest were shared during the 2022 AUA Annual Meeting. According to Avenda, the study showed that, “iQuest improved tumor margin creation² over conventional treatment planning from 56% to 80%³.”

"We are excited about the potential to unlock precision care in prostate cancer with iQuest, as it is a key enabling technology for focal therapy to be a reality for urologists and patients," Shyam Natarajan, PhD, co-founder and CEO of Avenda Health, stated in the press release.¹ "In order for a doctor to treat focally, they need to know where cancer is and the healthy tissue to avoid. This is vital information that iQuest now provides. This is a huge step forward in transforming the standard of care in prostate cancer and brings us that much closer to offering effective therapy that preserves quality of life to providers and patients across the United States."

Practical application of iQuest

According to Avenda, iQuest can be used with multiple treatment approaches to guide a doctor’s plan for patient care. For example, the FDA previously granted its investigational device exemption (IDE) to Avenda FocalPoint ablation system, which is powered by iQuest.⁴

FocalPoint combines iQuest’s AI-based margin prediction software algorithms with its focal laser ablation device to deliver treatment directly to the prostate tumor while sparing healthy tissue in surrounding areas. The IDE has enabled the launch of a new trial comparing FocalPoint to standard care in patients with localized prostate cancer.

FocalPoint previously received the FDA’s breakthrough device designation.⁵

References

1. First AI-Powered Precision Oncology Platform for Prostate Cancer Care, iQuest™, Receives FDA Clearance. Published online December 7, 2022. Accessed December 9, 2022. https://prn.to/3FiYl23

2. Priester A, Fan R, Shubert J, Colina J, Rusu M, Sulaiman V, Shao W, Khandiwala YS, Natarajan S, Sonn GA. A novel AI-derived metric identifies favorable candidates for focal therapy of prostate cancer and accurately predicts treatment margin efficacy. American Urological Association; Engineering and Urology Society. New Orleans, LA. May 15, 2022.

3. Priester A, Fan R, Shubert J, Colina J, Rusu M, Sulaiman V, Shao W, Khandiwala YS, Natarajan S, Sonn GA. Defining prostate cancer focal therapy treatment margins with a machine learning model: improvement upon hemi-gland ablation. American Urological Association; Engineering and Urology Society. New Orleans, LA. May 15, 2022.

4. Avenda Health Receives FDA Investigational Device Exemption for AI-enabled Prostate Cancer Therapy. Accessed August 9, 2022. https://prn.to/3Qhrzmj

5. Avenda Health Granted FDA Breakthrough Device Designation for Technology to Treat Prostate Cancer Published online May 11, 2021. Accessed May 11, 2021. https://bwnews.pr/3bgp80L.