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Health Canada Issues a Notice of Compliance for FDG
 International PET Diagnostics Inc. (“IPET”) has
added another first to its leadership position in the provision of diagnostic imaging services to cancer patients and their doctors. IPET was the
first in Canada to make PET scans available to cancer patients on a doctor referral basis when it opened the Vancouver PETSCAN Centre six years ago.
One month ago IPET Pharmaceuticals Inc. became the first in Canada to be issued a Health Canada Notice of Compliance (NOC) for the radiopharmaceutical
drug, FDG, used in PET scanning.
This NOC is the culmination of five years of clinical trials dealing with the safety of FDG (which was never really an issue) and its efficacy
in helping specialists to detect and evaluate major indications of cancer. The trials, conducted at the Vancouver PETSCAN Centre using IPET
Pharmaceutical’s CanTrace (™) FDG, studied a number of the major indications of cancer and kept statistics of all of the PET scans done in all
indications of cancer. The results were compared with those reviewed in meta-analyses of worldwide literature on the use of FDG-PET for cancer
indications. CanTrace FDG was approved for use by Health Canada in conducting PET scans for lung, breast, and colorectal cancer investigations.
The NOC is a significant step in the deliberate pace of Health Canada and the provincial Health Ministries and their cancer agencies toward
integration of this technology into the mainstream of Canada’s cancer identification, evaluation, and treatment system. The use of FDG-PET is
recognized by all the world’s developed countries as being a gold standard technology for cancer management. There will finally now be
licensed FDG available to PET providers in Canada, freeing them from the restrictions and constraints of using FDG as an investigational drug
under Clinical Trials when in reality they are doing clinical diagnostic work. For them, there is no further need to “investigate” their
FDG where IPET Pharma’s CanTrace FDG is available, not only for the three major cancer types, but also, on an “off label” basis for other
cancers as prescribed by physicians.
IPET Pharma will begin to establish a Canada-wide FDG delivery system, with radiopharmacies in strategic locations, in the next year.
The short half-life (2 hours) of FDG means that there are significant logistical challenges around the timely provision of FDG. IPET
Pharma is developing strategic alliances with industry participants to achieve a reliable production distribution network which will
enable PET scan providers to provide their services efficiently and effectively. As a result, Provincial health administrators will,
in the next little while, have to start taking more serious notice of this superb technology.
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