Health Canada Approves Saladax’s 5-Fluorouracil Chemotherapy Therapeutic Drug Monitoring (TDM) Test
May 14 2024 - 10:00AM
Health Canada Approves Saladax’s 5-Fluorouracil Chemotherapy
Therapeutic Drug Monitoring (TDM) Test
Saladax Biomedical, Inc. (Saladax) is pleased to announce that
Health Canada has approved Saladax’s 5-Fluorouracil
(My5-FU) Assay for sale in Canada in a rapid six days. This
approval recognizes the vital importance of implementing updated
guidelines and using 5-Fluorouracil (5-FU) TDM to ensure patients
undergoing cancer treatment with this chemotherapy agent get the
proper dose.
There is increasing concern with 5-FU treatments worldwide
because some patients suffer severe toxicities and even death,
which may have been avoided. There is growing frustration in the
medical community with oncologists who are reticent to adopt the
recommended guidelines for 5-FU TDM.
Today, 5-FU infusions are dosed using an antiquated method
called “Body Surface Area (BSA).” This method, developed in 1916,
is recognized as inadequate. BSA dosing does not account for
individual differences between patients, nor does it measure the
blood level of the drug in the patient. Multiple studies have
demonstrated that most patients are not getting the right dose.
Pharmacology guidelines highly recommend that 5-FU levels be
measured and adjusted on a patient-by-patient basis. By adjusting
the dose to fit the patient, efficacy is improved, and toxicity is
minimized.
The Saladax My5-FU blood test, used in multiple countries
worldwide, is now approved in Canada, the European Union, China,
the United Kingdom, and Israel. The only major country where it is
not approved is the United States. The test is remarkably
straightforward to implement. Requiring just one blood sample
during a chemotherapy cycle, it can easily be run on analyzers
already present in clinical laboratories, making levels practical
and accessible to healthcare professionals.
“It's imperative that we move away from the assumption that a
patient receives the appropriate 5-FU dose based on a
one-size-fits-all approach, which is often not the case. The use of
real-time blood levels to guide 5-FU therapy management”, as
advocated by Salvatore Salamone, Saladax’s CEO “is a critical step
forward. How many more patients will unnecessarily suffer from
incorrect dosing before this issue is addressed in the US?”
ABOUT SALADAX BIOMEDICAL, INC.
Headquartered in Bethlehem, PA, Saladax Biomedical, Inc. is a
privately held company that develops, manufactures, and markets
assays that provide rapid therapeutic drug levels for essential and
life-saving medicines prescribed by psychiatrists and oncologists.
Since 2007, Saladax's proprietary technology has been used in
clinical laboratories or point-of-care settings to assist
clinicians in monitoring and optimizing patient care. Additionally,
the company collaborates with leading pharmaceutical companies to
develop tests for clinical trials and companion diagnostics. For
more information, visit MyCareTests.com
- Saladax Biomedical, Inc. 5-FU Fact Sheet
- Saladax Biomedical, Inc. 5-FU Fact Sheet