2026
- Patients start receiving [Ga-68]DOTATOC released by Tracer-QC
2025
- Patients start receiving [Ga-68]PSMA released by Tracer-QC
- Tracer-QC systems installed and qualified in North America, Europe, Asia, Middle East
- Tracer-QC kit production qualified under ISO13485 standards
2024
- Tracer-QC qualified in the field for QC of 4 new PET tracers
2023
- First regulatory approval for the use of Tracer-QC in Europe for release EP FDG
- Patients start receiving [F-18]FDG released by Tracer-QC
2022
- Substantial quantitative improvements over conventional QC documented in the field.
2021
- Tracer-QC IP protection expanded by new issued patent (US 10,895,563)
- “Automation of PET QC” Chapter 14
in “2021 Handbook of Radiopharmaceuticals” presents the value of Tracer-QC to broad audience.
2020
- Massachusetts General Hospital (MGH) demonstrates robust performance of Tracer-QC in the field with over 30 consecutive runs.
- Tracer-QC rHPLC validated for QC of [F-18]Florbetaben (NeuraCeq) and [F-18]Fluoroestradiol (CERIANNA)
- Feasibility of Tracer-QC application for both QC and synthesis of ImmunoPET tracers established (NCI project 43CA235909)
2019
- First patent issued on Tracer-QC technology (US 10, 309,947)
- Tracer-QC validation found acceptable by the FDA Technical Committee (project FD005517)
2018
- First order received for Tracer-QC rHPLC
- First validation of Tracer-QC for FDG completed in the field
- First Tracer-QC systems delivered to customers
- First FDA approval for use of Tracer-QC at MGH Press Release (Download)
2017
- First order received for Tracer-QC product.
- Tracer-QC product launched at SNMMI-2017.
- NCI awards Trace-Ability Phase II SBIR Grant for the development of next generation system, Tracer-QC rHPLC (R44CA192499).
2016
- Tracer-QC validation studies start at Zevacor Pharma
- NSF awards Trace-Ability Phase II SBIR Grant for the development of pilot kit production (IIP-1555815).
- NSF (IIP‐1446677) and NCI (1R43CA192499-01) Phase I SBIR Grants successfully completed achieving all objectives.
2015
- Trace-Ability receives funding from the FDA for an FDA-collaborative project focused on validation of Tracer-QC for PET tracer release testing (U01FD005517).
- Tracer-QC concept makes its first appearance at a trade show. More than 100 visitors inquired about the system at SNMMI-2015 (Society of Nuclear Medicine and Molecular Imaging) in Baltimore MD.
- NSF and NIH award two SBIR grants for the development of Tracer-QC®.