Spartan Bioscience announces first point-of-care DNA testing system
for personalized medicine
18 August 2010
Canadian company Spartan Bioscience Inc has announced the
availability of the Spartan RX, a complete sample-to-result,
point-of-care DNA testing system for personalized medicine.
The non-invasive and easy-to-use system provides automated results
in one hour. The test is currently available for
investigational testing by doctors and scientists.
The first available test, Spartan RX CYP2C19, was designed to
help cardiologists identify patients who have a gene mutation that
causes impaired metabolism to the popular anti-blood clotting
medication Plavix (clopidogrel), which may lead to major adverse
The CYP2C19 mutation is found in up to 30% of the world’s
population. These gene carriers who receive the standard dose of
Plavix following a cardiac stent insertion to open clogged arteries
have an 11.7% absolute risk of death, stroke, or heart attack in the
first year compared to 8.3% for non-carriers.
The US Food and Drug Administration issued a warning for Plavix
in March 2010. The genotype results provided by the Spartan RX
CYP2C19*2 test will help determine the most effective anti-blood
clotting drug and dosage at the onset of heart attacks.
“Currently, genetic testing for Plavix non-response is performed
in central labs and it takes one to seven days to get a test result
back. This is often too late because most of the complications for
CYP2C19*2 carriers occur in the first 24 to 48 hours,” said Derek
So, MD, staff cardiologist, University of Ottawa Heart Institute.
“As a one-hour point-of-care test, the Spartan RX CYP2C19 has the
potential to significantly reduce major cardiac events in heart
"The long-term trend for DNA testing is to move from the central
lab to point-of-care," said Paul Lem, MD, founder of Spartan
Bioscience. "Spartan has turned this prediction into reality by
creating a fully integrated DNA collection, extraction and analysis
platform, and adding an intuitive interface that can be operated by
nurses and other non-technical users."
The Spartan RX System and Spartan RX CYP2C19 test are currently
available for investigational testing. At the University of Ottawa
Heart Institute, Dr So is using the testing system to run the RAPID
GENE study, a prospective randomized clinical trial, which will
determine if alternative anti-blood clotting therapy with Effient (prasugrel)
for CYP2C19*2 carriers reduces major adverse cardiovascular events.
Spartan Bioscience plans on using the results from the clinical
trial to secure the appropriate regulatory approvals around the
“Over the course of 5 years, Spartan Bioscience has developed a
flexible, point-of-care DNA testing system that enables us to enter
new multi-billion dollar markets,” said Larry D'Andrea, CEO of
Spartan Bioscience. “The Spartan RX CYP2C19 is the first of many
personalized medicine tests designed to help reduce adverse events
to blockbuster drugs and ultimately, save thousands if not millions