|
Basel, Switzerland, December 17, 2003
Roche Diagnostics First Company to Receive U.S. Clearance and European
CE Mark for Two New Thrombophilia Genetic Disorder Tests
Real-time PCR tests are the first in vitro diagnostic products
on Roche's LightCycler Instrument
Roche Diagnostics today announced the launch of its new Factor
V Leiden Kit and Factor II (Prothrombin) G20210A Kit for its LightCycler®
real-time PCR instrument. Both tests allow the detection and genotyping
of inherited mutations in the genes that encode the Factor II and
Factor V proteins, as an aid to diagnosis in the evaluation of patients
with suspected thrombophilia. Inherited thrombophilia predisposes
an individual to thrombotic events such as venous thrombosis, the
third most common cardiovascular disease.
The kits received 510(k) clearance under an accelerated review
/ de novo process from the U.S. Food & Drug Administration (FDA)
this week, and also bear the CE Mark, which expresses conformity
with the requirements of the European IVD Directive and allows distribution
within the European Union. The tests are now available in Europe
for commercial sales and will be available for commercial sale in
the U.S. in early 2004.
"Creating the first FDA-cleared human DNA-based genetic disorder
tests demonstrates the leadership of Roche in molecular diagnostics,
and is symbolic of the developments Roche Diagnostics continues
to achieve on this 20th anniversary of PCR. The clearance for these
types of tests increases access to genetic testing technology important
for today's blood clotting mutation identification, and opens the
door to future advances using Roche's MagNA Pure and LightCycler
products," said Heino von Prondzynski, Head of Roche Diagnostics
and Member of the Roche Executive Committee.
The two in vitro diagnostic tests have been specifically developed
for real-time PCR using Roche's LightCycler instrument. Both kits
were initially introduced to the market as RUO (research use only)
products in 1999. The components of the kits are designed to maximize
test performance with minimal handling steps.
The American College of Medical Genetics and the College of American
Pathologists have issued consensus statements recommending measurement
of heritable thrombophilic risk factors, such as Factor V Leiden
and Prothrombin G20210A in patients with suspected thrombophilia.
About the LightCycler Instrument and New IVD Tests
The LightCycler instrument combines an innovative thermal cycler
platform with a fluorescence detection system. With proven performance
in the research market for over five years, the instrument combines
rapid-cycle PCR with real-time fluorescence monitoring.
The IVD kits provide primer, hybridization probes for sequence-specific
detection and determination of the genotype, pre-mixed reagents,
a control template and PCR grade water. Only patient sample DNA
has to be added. These kits are designed for 32 reactions and a
maximum of 30 samples. For preparation of human genomic DNA from
whole peripheral blood, automated nucleic acid purification can
be performed using the MagNA Pure LC Instrument in combination with
the MagNA Pure LC DNA Isolation Kit I. Alternatively, a manual method
employing the High Pure PCR Template Preparation Kit can be used.
About Roche and Roche Diagnostics
Headquartered in Basel, Switzerland, Roche is one of the world's
leading innovation-driven healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. Roche is number one in the
global diagnostics market, the leading supplier of pharmaceuticals
for cancer and a leader in virology and transplantation. As a supplier
of products and services for the prevention, diagnosis and treatment
of disease, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche employs roughly
65,000 people in 150 countries. The Group has alliances and research
and development agreements with numerous partners, including majority
ownership interests in Genentech and Chugai. Roche's Diagnostics
Division, the world leader in in-vitro diagnostics with a
uniquely broad product portfolio, supplies a wide array of innovative
testing products and services to researchers, physicians, patients,
hospitals and laboratories worldwide.
LightCycler is a registered trademark of a member of the Roche
Group. MagNA Pure and High Pure are trademarks of a member of the
Roche Group.
For additional information contact:
|
