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TEST:
TriNetra™

Type:
CE Marked
Related tests:
Evidence

News

over1year
Early Detection of Breast Cancer (clinicaltrials.gov)
P=N/A; N=700; Recruiting; Sponsor:Datar Cancer Genetics Inc
New trial • Tumor cell
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TriNetra™
2years
Clinical validation of “TriNetra™-Breast” test for breast cancer screening in a prospective, observational, case-cohort study (SABCS 2022)
The results of TriNetra™-Breast will be compared with the results of mammography and/or histopathology for performance estimation of the test. Study participants will be followed for clinical outcomes for maximum duration of 2 years.
Observational data • Clinical
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TriNetra™
3years
FDA Grants Breakthrough Designation for Early-Stage Breast Cancer Detection Blood Test Developed by Datar Cancer Genetics (PRNewswire)
"Datar Cancer Genetics...announced that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™' blood test to detect early-stage Breast Cancer...TriNetra™ uses a proprietary technology developed by the Company to detect Circulating Tumor Cells (CTCs) specific to Breast Cancer. Studies have shown that TriNetra™ can detect even Stage 0 (DCIS) and Stage 1 cancers with high accuracy. The test requires only 5 ml blood and is indicated for asymptomatic women above the age of 40 years with a physician's prescription."
Breakthrough therapy designation • FDA event
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TriNetra™