TRAQinform IQ

by AIQ Global  · Based in United States →Advanced AI for Quantitative Oncology Treatment Response
Nuclear Medicine Oncology Radiology

Regulatory Status Disclosed

Overview

TRAQinform IQ by AIQ Solutions (AIQ Global) is an FDA-cleared software medical device designed to provide automated, lesion-level quantitative analysis of treatment response in patients with complex, late-stage, or metastatic cancers.

The software is built for trained medical professionals, including:

  • Oncologists
  • Nuclear medicine physicians and radiologists
  • Medical imaging technologists, dosimetrists, and physicists

Operating in clinical oncology and radiology workflows, TRAQinform IQ utilizes serial radiographic images, such as PET and CT DICOM 3.0 volumetric scans. Images are uploaded securely to the cloud, where the software automatically segments anatomical structures and matches regions of interest (ROIs) across longitudinal scans. This process tracks the behavior of individual lesions over time to evaluate intra-patient treatment heterogeneity.

Notable capabilities of the platform include:

  • Automated matching of ROIs between baseline and follow-up PET/CT and CT imaging.
  • Generation of visual and quantitative reports detailing the rate of change (slope) and spatial location of resistant disease for each tracked lesion.
  • Color-coded visual mapping to assist clinicians in distinguishing between responding and progressing lesions.
  • Support for monitoring multiple cancer types, including lung, prostate, bladder, head and neck, neuroendocrine, melanoma, and lymphoma.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Clinical decision support
  • Patient monitoring
  • Data analytics
  • Interoperability
  • Medical imaging
  • Automated anatomical and skeletal segmentation
  • Automated matching and quantitative assessment of ROIs between multiple PET/CT scans
  • Generates detailed reports on lesion volume and tracer uptake changes
  • Lesion-level analysis for treatment response heterogeneity
  • Real-time analysis and reporting

Use Cases

  • Monitoring disease progression in oncology
  • Monitoring treatment response in oncology and nuclear medicine
  • Adjusting therapies and optimizing clinical outcomes
  • Understanding treatment response heterogeneity in cancer patients
  • Guiding timely and effective treatment decisions for advanced cancer patients
  • Supporting early-stage clinical trials for drug effect and toxicity analysis

What Physicians Need to Know

Evidence Base
TRAQinform IQ leverages machine learning for anatomical and skeletal segmentation, automating the matching and quantitative assessment of regions of interest (ROIs) between multiple PET/CT scans. It performs quantitative analysis of heterogeneity in lesion volume and tracer uptake, a methodology supported by published research. The foundational science, established in 2020, highlights that not all lesions respond uniformly to treatment, and resistance in a small percentage can significantly impact overall clinical outcomes. The tool's development is backed by a strong literature scope, including retrospective analyses and ongoing prospective studies.
Clinical Validation Studies
The software has been validated in multiple clinical trials and holds clearances from both the US FDA (510(k) K173444 and K233998) and the Australian TGA. A retrospective study involving patients with metastatic lung cancer (n=241) and lymphoma (n=114) demonstrated that TRAQinform IQ's analysis of all lesion-ROIs was more prognostic of overall survival compared to standard-of-care methods like RECIST and PERCIST. In another study, seven oncologists found the analysis useful in 98.1% of patients (101/103), with high utility for systemic therapy decisions (97%), targeted therapy decisions (72%), spatial location information (96%), and patient education (93%). Ongoing prospective studies are further evaluating its impact on treatment decision changes and detection of treatment effectiveness and adverse events.
Alert Fatigue Management
TRAQinform IQ provides real-time analysis and generates comprehensive, detailed reports for clinicians, rather than issuing frequent, discrete alerts. This report-based delivery model is designed to provide actionable insights without contributing to alert fatigue.
Guideline Update Frequency
While a specific update frequency for guidelines is not stated, TRAQinform IQ is based on machine learning models and algorithms that undergo continuous development, rigorous verification, and validation testing. The approval of a new Category III CPT code in March 2026 signifies ongoing recognition and integration within the medical community.
Clinical Workflow Integration
The software is designed for seamless integration into existing clinical workflows, operating in a secure cloud environment with web browser access. Images (e.g., PET, CT) are uploaded via a HIPAA-compliant cloud, and comprehensive reports are generated and delivered to the oncologist. AIQ Solutions emphasizes streamlining requests, image transfer, and report delivery, with a dedicated Quality Manager overseeing the end-to-end clinical workflow to ensure high standards. The company is also working towards securing insurance and Medicare reimbursement to facilitate broader adoption.
Decision Audit Trail
While a specific 'decision audit trail' feature within the software isn't explicitly detailed, the tool generates comprehensive, quantitative reports based on imaging data. These detailed reports serve as a record of the analysis provided, contributing to the overall clinical audit trail. The company's adherence to regulatory compliance (FDA, TGA, HIPAA, GDPR, SOC 2, ISO certifications) implies a focus on traceability and accountability of its analytical output.
Physician Tip

TRAQinform IQ provides granular, lesion-level insights into treatment response heterogeneity, which can significantly enhance precision medicine in oncology. Physicians should integrate these detailed quantitative reports with traditional imaging assessments and other clinical data for a more comprehensive understanding of disease progression. The visual reports, highlighting responding and progressing lesions, can be particularly valuable for tailoring treatment regimens and for patient education. Remember that while the tool offers advanced analysis, multidisciplinary review is still crucial for binary patient-level progression decisions, especially when discrepancies arise with local PET/CT reporting.

TRAQinform IQ is a cloud-based solution designed for seamless integration into existing clinical workflows, supporting various data standards including FHIR, HL7 v2, DICOM, SNOMED, and ICD-10. Its operation in a secure cloud environment with web browser access facilitates ease of use and scalability. The system is built to receive serial radiographic images (e.g., PET, CT) via the cloud and deliver comprehensive reports back to the oncologist, aiming to streamline the entire process from image acquisition to clinical decision-making.

Details

Category Oncology AI, Radiology & Imaging AI
Pricing Unknown
DeploymentSaaS; cloud-based; on prem; hybrid; web browser access
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

TRAQinform IQ is an FDA-cleared (510(k)) software medical device for clinical use in monitoring various cancer types, including lung, prostate, bladder, head and neck, neuroendocrine system, lymphoma, and melanoma.

Integrations
EHR Not specified
Specialties Nuclear Medicine, Oncology, Radiology

What the Web Says

TRAQinform IQ is an FDA 510(k) cleared software that utilizes algorithm-based analysis of medical images (FDG PET/CT) to provide oncologists with quantitative information on treatment response in metastatic cancer patients. Physicians have found the analysis to be highly useful for overall clinical utility, systemic therapy decisions, spatial location information, and patient education. The technology also significantly expedites the matching process of regions of interest (ROI) in high-burden cases compared to manual physician review.

Overall: Positive

Strengths

  • High clinical utility for oncologists in treatment response analysis.
  • Provides distinct and quantitative information not typically found in standard radiology reports.
  • Excellent accuracy for anatomic structure segmentation and lesion-ROI detection.
  • Significantly faster automated ROI matching compared to manual physician methods.
  • Useful for systemic therapy decisions, targeted therapy decisions, spatial location information, and patient education.
  • FDA 510(k) cleared software, indicating regulatory validation.

Limitations

  • One study showed lower usefulness for targeted therapy decisions compared to other categories (72%).
  • No specific negative reviews or opinions from tech reviewers, Reddit, G2, or Capterra were found for TRAQinform IQ, though general reviews for other 'IQ' products on these platforms sometimes mention issues like inflated scores, subscription scams, or complex reporting.

Based on reviews from: Clinical Meaningfulness of an Algorithm-Based Service for Analyzing Treatment Response in Patients with Metastatic Cancer Using FDG PET/CT - PMC, News u2013 AIQ Global

Last updated: 2026-07-17

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Press & Coverage

PR Newswire
AIQ Solutions Announces a New Category III CPT Code for Determining Heterogeneity of Change Across All Lesions for Advanced Metastatic Cancer Used with TRAQinform IQ Technology
AIQ Solutions announced that the American Medical Association (AMA) has approved a new Category III CPT code for its TRAQinform IQ technology, which provides lesion-level analysis for advanced metastatic cancer. This code aims to make advanced treatment response intelligence more accessible to oncologists and patients.
2026-03
ASCO Publications (Journal of Clinical Oncology)
Prospective, non-interventional, multisite evaluations of TRAQinform Immuno algorithmic quantitative treatment response analysis on treatment intent decisions in metastatic melanoma.
This prospective, multisite study found that TRAQinform IQ analysis of FDG PET/CT images influenced oncologists' treatment decisions in the majority of metastatic melanoma patients, suggesting it provides clinically actionable information.
2026-05
Isthmus Project
AIQ Solutions earns new Category III CPT code for comprehensive lesion-level assessment of Metastatic Cancer
AIQ Solutions has received a new Category III CPT code for its TRAQinform IQ platform, a quantitative imaging solution that evaluates treatment response at the lesion level across a patient's entire disease. This code supports standardized reporting and lays the groundwork for broader adoption and potential reimbursement.
2026-03
PR Newswire
AiQ Launches Enterprise AI Platform for the U.S. Market with Support from EntryPoint Boston
AiQ (an unrelated company) announced its expansion into the U.S. market with the launch of its Enterprise AI platform, designed to help organizations improve their Work IQ by connecting data and building AI agents.
2026-04
Journal of Nuclear Medicine
Prognostic Value of AI-Assisted Lesion Tracking on End-of-Treatment PSMA PET in mCRPC Patients Treated with 177 Lu-PSMA: A Retrospective, Single-Center Study
This study utilized TRAQinform IQ technology to provide response assessment through lesion-tracking comparison of PSMA PET scans in metastatic prostate cancer patients, allowing for in-depth quantitative analysis of lesion-by-lesion changes.
2025-09
CancerX
Precision Medicine Platform AIQ Solutions Takes CancerX Discovery Award
AIQ Solutions received the inaugural CancerX Discovery Acceleration Award for its TRAQinform IQ solution, which provides novel information about quantifying changes in regions of interest over time to optimize therapies for metastatic cancer.
2025-07
GlobeNewswire
Blackford and AIQ Solutions Announce Commercial Partnership to Bring Advanced Clinical Decision Support Tools for Metastatic Cancer to Healthcare Providers
Blackford and AIQ Solutions announced a commercial partnership to provide healthcare professionals with advanced clinical decision support tools for metastatic cancer, leveraging AIQ Solutions' FDA-cleared TRAQinform IQ technology.
2023-11
PMC (Physics in Medicine & Biology)
Quantitative evaluation of lesion response heterogeneity for superior prognostication of clinical outcome
This study, published in Physics in Medicine and Biology, details how TRAQinform IQ software performs quantitative analysis of heterogeneity of change in volume and tracer-uptake using automated matching of lesion-ROI between FDG PET/CT images.
2024-05

Videos

Product demos, reviews, and walkthroughs for TRAQinform IQ.

View all on YouTube

Frequently Asked Questions

TRAQinform IQ is a cloud-based software designed to integrate seamlessly into existing clinical workflows. It processes DICOM-compliant PET/CT imaging data, providing quantitative analysis of lesions as an adjunct to locally reported image interpretation.
TRAQinform IQ offers detailed lesion-level analysis, quantifying changes in volume and tracer uptake for individual lesions across multiple PET/CT scans. This allows for earlier and clearer insights into treatment response heterogeneity, which can influence treatment strategy.
Yes, TRAQinform IQ is FDA-cleared for clinical use and has been validated in multiple clinical trials. It also adheres to compliance standards such as HIPAA, GDPR, HITECH, and SOC 2.
Yes, the American Medical Association (AMA) has approved a new Category III Current Procedural Terminology (CPT) code for the unique analytical output produced by TRAQinform IQ technology. While Category III codes are for tracking and not yet eligible for reimbursement, this represents a significant step towards broader clinical adoption and potential future payment.
TRAQinform IQ specializes in quantitative, lesion-level analysis of PET/CT scans, providing detailed reports on individual lesion changes and heterogeneity of response. This contrasts with traditional methods that often rely on a limited subset of lesions or broader imaging assessments.
TRAQinform IQ operates on a subscription-based pricing model. Specific pricing details are not publicly available and require direct contact with the vendor, AIQ Global.
While highly informative, TRAQinform IQ's use has not been established for binary patient-level progression or non-progression decisions without multidisciplinary review. It is intended as an aid to trained medical professionals, not a standalone diagnostic tool.

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Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
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