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).

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

General Information

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

Technical Specifications

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

Regulatory

Certification
CE	Certified, Class I , MDD
FDA	No or not yet
Intended Use Statements
Intended use (according to CE)	TRACE4OC is indicated for women at risk of ovarian cancer on the recommendation of gynecology specialists. Physicians with expertise with pelvic US can use TRACEOC to support the reporting on US-detected adnexal masses investigations in these subjects. Specialists in gynecology can use TRACE4OC as an aid to diagnosis. TRACE4OC software provides the subject level of risk (very low risk or medium-high risk) of being affected with ovarian cancer at the date of the TRACE4OC-processed US 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 US study, and with the current woman’s menopausal state (premenopausal or post menopause). However, it should be noted that DeepTrace Technologies S.R.L. considers TRACE4OC as a support to gynecology specialists in their diagnosis, and as a support to physicians with expertise with pelvic US in their reporting on adnexal masses. These medical professionals keep the final decision-making responsibility.

Market

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

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