News and Updates

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)
  • Drug Master File (#029891) filed with the FDA and available for cross-reference.

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.
  • Trace-Ability signs partnership agreement with LabLogic Systems, Ltd. which accelerates product launch and makes Tracer-QC available worldwide through LabLogic’s extensive network.
  • NSF and NIH award two SBIR grants for the development of Tracer-QCTM.