TRACE4OC

DeepTrace Technologies Srl

TRACE4OC provides the woman's level of risk (very low risk or medium-high risk) of being affected with ovarian cancer at the date of the TRACE4OC-processed USI investigation of an adnexal mass, combined with the serum level test for Cancer Antigen 125 (CA-125), performed no earlier than and no later than one month from the USI study, and with the current woman’s menopausal state (premenopausal or post menopause).

Product specifications

Information source: Vendor
Last updated: Nov. 18, 2021

General
Product name	TRACE4OC
Company	DeepTrace Technologies Srl
Subspeciality	Abdomen
Modality	Ultrasound
Disease targeted	Ovarian cancer
Key-features	Classification of risk of having ovarian cancer
Suggested use	During: report suggestion After: diagnosis verification
Data characteristics
Population	Women at risk of ovarian cancer on the recommendation of gynecology specialists
Input	Transvaginal US, 2D, single slice, ovarian mass, CA-125
Input format	DICOM
Output	Classification of medium-high risk vs very low risk, automated report
Output format	PDF
Technology
Integration	Stand-alone third party application
Deployment	Locally on dedicated hardware
Trigger for analysis	On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time	3 - 10 seconds
Certification
CE	Certified, Class I , MDD
FDA	No or not yet
Market presence
On market since	05-2021
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model	Subscription
Based on	Number of users, Number of installations
Evidence
Peer reviewed papers on performance	A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125 (read)
Non-peer reviewed papers on performance
Other relevant papers