AI Prognostic Tool for NSCLC Earns FDA Breakthrough Designation

by time news

AI-Powered Prognostic⁣ Tool for Lung Cancer: A New Era in Personalized Oncology Care

The FDA‍ has granted breakthrough device designation to ⁣serial CTRS, an‍ AI-powered ⁤prognostic tool developed by onc.AI. This innovative ⁣technology ‌aims to revolutionize the⁢ way ‍non-small⁣ cell lung cancer (NSCLC) ‌is treated by‌ stratifying patients into high- or low-risk mortality categories based on ‌thier individual characteristics and medical‌ history. ⁢

“We are honored ‍to be awarded ⁤breakthrough ⁢device designation for our Serial CTRS AI model,”⁣ said ⁤Akshay Nanduri, ⁤CEO of Onc.AI,in a press release. “Onc.AI aims to equip oncologists⁤ with vital, automated prognostic insights using routinely collected diagnostic ⁢imaging scans‌ and‍ ultimately improve treatment strategy and provide risk stratification throughout [the] journey [for a patient with cancer].” 1

How ‌Serial ⁢CTRS Works:

Serial CTRS utilizes ⁢a deep-learning model trained​ on real-world datasets from patients with advanced NSCLC who received immune checkpoint inhibitor therapy. The model analyzes⁢ serial CT scans, identifying ‍patterns and features ⁢that correlate ‌with patient outcomes.⁤ this ⁢analysis goes beyond customary methods like manual tumor volume ⁤segmentation and RECIST 1.1 response categories, providing a more comprehensive and accurate prediction ⁢of survival.The model’s‌ performance has been validated using ‍additional real-world data,‍ demonstrating superior predictive accuracy. The C-index for predicting overall survival (OS) was significantly higher with Serial CTRS​ (0.734)​ compared to‌ RECIST (0.631) and tumor volume measurement⁤ changes (0.679). Furthermore, in patients with ‍stable⁢ disease, Serial CTRS showed a 12-month area under the receiver operating ​characteristic (AUROC) curve of 0.74,outperforming tumor volume⁢ change (AUROC 0.62). 2

Benefits for Patients and Oncologists:

The potential benefits of⁣ Serial CTRS are significant ⁢for both ‍patients and ⁢oncologists:

Personalized Treatment: By accurately⁢ predicting individual patient outcomes, Serial CTRS allows oncologists to tailor treatment plans to ‍each ⁢patient’s unique needs and‌ risk profile.⁣ This personalized approach can lead to more effective⁢ treatment strategies and ⁢improved patient outcomes.
Early Intervention: Serial CTRS can identify patients​ at high risk of poor outcomes early on, allowing for ⁢timely interventions and potentially‌ improving survival ‌rates.
Reduced Healthcare Costs: By optimizing treatment strategies and avoiding unneeded interventions ⁢for low-risk patients, Serial CTRS can potentially reduce healthcare costs associated with ⁣unnecessary treatments.

The Future of AI in Oncology:

Serial CTRS ⁤represents a significant step⁣ forward in the application of AI in oncology. As AI technology continues to advance, we can expect to see even more refined​ tools that will further personalize cancer care and⁢ improve patient outcomes.

Jacqueline law, Vice President‍ of Corporate Strategy​ at Flatiron Health, highlighted the importance of real-world data in AI ⁤progress, stating, “We are ‍thrilled to see the application of Flatiron’s high-quality, curated real-world data⁣ in the development and validation of regulatory-grade AI models for clinical use.” 1

Dwight Owen, MD, MS, Associate Professor⁢ of Medicine and Head of Thoracic Oncology at the ‌James Cancer‍ Center at Ohio State University, expressed his excitement for the‌ potential of‌ Serial CTRS, ​stating, “Having been involved in product definition and evaluating‌ results throughout the evolution of ‍this product, I ​look forward ‍to seeing this breakthrough technology ⁢enter⁤ the clinic and impact ⁤early phase trials and clinical ‍development.” 3

Conclusion:

serial CTRS is a groundbreaking development in the field of oncology, offering a powerful tool for ​personalized cancer⁣ care. as AI technology continues to evolve, we can expect to‌ see⁣ even more⁤ innovative applications that ‌will transform the ⁣way‍ cancer is diagnosed, treated, ⁤and managed.

References:

  1. Onc.AI awarded FDA breakthrough device designation for ​Serial CT Response Score deep learning model. News release. ⁣Onc.AI. February 6, 2025. Accessed February 10, 2025. https://tinyurl.com/3a2m2hrd
  2. Sako C,⁢ Schmidt TG, Patel AA, et al. Deep learning serial CT response score predicts overall survival in advanced NSCLC⁢ treated ‍with‍ PD-(L)1 ⁤immune checkpoint inhibitors.

J Immunother Cancer*. 2024;12(suppl ⁤2):1237. doi:10.1136/jitc-2024-SITC2024.1237

  1. Onc.AI Serial Imaging​ Response Score outperforms traditional methods for early assessment of NSCLC immunotherapy outcomes. News release. Onc.AI.november 6, ‍2024. Accessed ⁣February 10, 2025. https://tinyurl.com/3rmsfnr8

AI Predicts Lung Cancer Outcomes: A ​Conversation​ with Time.news‍

Time.news‍ Editor: ​ We’re excited to talk today about the​ groundbreaking AI tool, Serial ⁤CTRS, which has just received breakthrough device designation from the ⁢FDA for⁢ its potential in personalized lung cancer treatment.

Future Oncology expert: ⁤It’s ​a very exciting‍ time in oncology! This AI-powered prognostic tool has the potential to​ revolutionize how‌ we approach non-small cell⁤ lung cancer (NSCLC) treatment.

time.news Editor: Can you⁣ explain how Serial CTRS works and what makes it so different ⁤from existing methods?

Future​ Oncology Expert: Absolutely. Serial CTRS uses a deep-learning model trained⁣ on real-world patient data, specifically focusing on‌ advanced NSCLC⁣ patients ⁣treated with immune checkpoint inhibitor⁢ therapy. It analyzes serial CT scans, looking for patterns and ‌features that correlate with patient outcomes. ​

unlike​ customary​ methods that rely solely on tumor volume measurements or RECIST 1.1 response categories,Serial ​CTRS ⁤offers a ⁣more comprehensive‍ analysis. It’s⁤ shown to significantly outperform‌ these methods​ in predicting overall survival, even in patients with stable ⁣disease. ⁤

Time.news Editor: This sounds incredibly promising. What specific benefits does this bring to patients and ⁣oncologists?

Future Oncology Expert: Well, imagine knowing exactly how a patient’s cancer is likely to progress.‍ Serial CTRS provides that personalized insight. Oncologists can use this information ​to ⁣tailor treatment plans, ‌choosing the⁣ most effective approach for each individual patient. This⁤ personalized approach has ​the ⁢potential to improve treatment outcomes ⁣and perhaps extend survival rates.

Moreover, Serial CTRS can ‍help identify patients at high risk ⁤early on, allowing for timely interventions.

Time.news Editor: Are‌ there any potential implications for healthcare costs?

Future ‌Oncology Expert: Absolutely. By optimizing ⁤treatment strategies ⁣and avoiding unnecessary interventions for low-risk patients, Serial CTRS has the potential ⁤to​ reduce healthcare costs associated with overly aggressive treatments.

Time.news Editor: ⁤ The ‌article mentions Real-World Data⁤ (RWD) playing a crucial role. Why is that so crucial ​for AI development in ⁤oncology?

Future Oncology Expert: Real-world⁢ data is absolutely essential. AI models learn from the ‍vast amounts of ‍patient information⁣ contained in RWD. ⁢this⁣ real-world context helps ensure the ⁣AI tool accurately reflects the complexities of cancer and individual patient characteristics.‌

Time.news ‌Editor: Looking ⁣ahead, what’s​ the future⁤ for AI in oncology?

Future Oncology Expert: We’re at the cusp of a revolution! AI‌ has the potential to transform every aspect of ⁣cancer care,⁤ from ⁤diagnosis to treatment and personalized monitoring. Tools like ⁢Serial CTRS are just ‌the beginning.

I‍ believe we’ll see even more complex ⁣AI-powered‍ solutions emerge,ultimately leading ⁢to more precise,personalized,and ultimately,more successful ‍cancer treatments.

Keywords: AI,⁤ Oncology, Lung Cancer, Serial CTRS, FDA Breakthrough⁣ Device, Personalized ‍Medicine, Treatment, predictive Analytics, Deep Learning,⁤ Real-World ⁢Data, RECIST,​ Immune ⁢Checkpoint Inhibitors, NSCLC, Healthcare Costs.

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