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Genzyme Launches New Cystic Fibrosis Gene Sequencing Test
Genzyme Corporation
(Nasdaq: GENZ) announced today the commercial availability of cystic
fibrosis (CF) gene sequencing, a new diagnostic test that can detect
approximately 98 percent of the more than 1,200 disease-causing mutations
in the CFTR gene. Mutations in the CFTR gene can cause CF, as well as other
health issues such as pancreatitis and male infertility. According to the
Cystic Fibrosis Foundation, more than 10 million Americans are carriers of
CF gene mutations.
"Our new test will help physicians identify a greater number of
patients that are impacted by CFTR-related diseases, and who otherwise may
not have been diagnosed," said Mara Aspinall, president of Genzyme
Genetics, the business unit of Genzyme Corp. focused on the research,
development and provision of complex testing services. "When you combine
our CF gene sequencing test with access to our knowledgeable geneticists,
we help physicians provide better, more informed care for their patients."
Most genetic CF testing is performed by mutation panels, which detect
the most common CFTR mutations. CF gene sequencing detects the most common
mutations, as well as less common mutations not included in the available
mutation panels.
Genzyme Genetics has been a leader in CF testing for more than fifteen
years, continually advancing testing by detecting more disease-causing
mutations and reducing testing turnaround times to get results to patients
faster. Genzyme's full CF gene sequencing test is a direct sequence
analysis of the CFTR gene.
Partial CFTR gene sequencing is also available for families with known
mutations not detectable in a general screening assay. The new test can be
performed on conventional samples, such as blood and prenatal specimens
including amniotic fluid and chorionic villi sampling (CVS). In addition,
Genzyme offers the new test on blood spot samples, a convenient alternative
that collects blood from a fingerstick, and does not require phlebotomy
services.
A Comprehensive CF Program
Genzyme Genetics offers a robust CF testing program that offers
informative results and access to genetics expertise. The program includes
CFplus(TM), an analysis of 97 mutations that provides high CF detection
rates for the pan-ethnic U.S. population in just five to eight days. This
test is available on blood serum, cheekbrush and mouthwash samples. CF gene
sequencing offers a more comprehensive answer in two to three weeks.
Genzyme also offers physicians access to board-certified clinical molecular
geneticists to discuss test results and genetic counselors for patients to
discuss what testing means for them.
About Cystic Fibrosis (CF)
Approximately 30,000 people in the United States are living with CF,
according to the Cystic Fibrosis Foundation. CF occurs at increased
frequency in Caucasians and individuals of Ashkenazi Jewish descent, but
can occur in any ethnic group. It is a disorder of mucus production,
primarily affecting the pulmonary, gastrointestinal and reproductive
systems. Although there is some variability of clinical expression, most
individuals with CF require lifelong medical care and experience reduced
life expectancy.
Couples who are planning a pregnancy or who are already pregnant may
decide to have testing to find out if they are carriers and at risk of
having a baby with CF. It is standard of care to offer carrier screening
for CF to Caucasian and Ashkenazi Jewish individuals and to inform couples
of other ethnic backgrounds of CF testing. If both parents are found to be
carriers, prenatal diagnosis by CVS or amniocentesis is available.
About Genzyme Genetics
Genzyme Genetics is a leading, nationwide provider of high-quality,
complex testing services for physicians and their patients. With CLIA-
certified laboratories and counseling facilities located across the U.S.,
Genzyme Genetics offers extensive diagnostic testing services, supported by
innovative technology and a commitment to quality service and trusted
information. Genzyme Genetics is a business unit of Genzyme Corporation.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. This year marks the 25th anniversary of Genzyme's
founding. Since 1981, the company has grown from a small start-up to a
diversified enterprise with more than 8,500 employees in locations spanning
the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by
FORTUNE as one of the "100 Best Companies to Work for" in the United
States.
With many established products and services helping patients in more
than 80 countries, Genzyme is a leader in the effort to develop and apply
the most advanced technologies in the life sciences. The company's products
and services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant and immune diseases, and diagnostic
testing. Genzyme's commitment to innovation continues today with a
substantial development program focused on these fields, as well as heart
disease and other areas of unmet medical need.
This press release contains forward-looking statements, including the
statements regarding the ability of CF gene sequencing to detect
approximately 98 percent of the more than 1,200 disease-causing mutations
in the CFTR gene and to help physicians identify a greater number of
patients that are impacted by CFTR-related diseases. These statements are
subject to risks and uncertainties that could cause actual results to
differ materially from those projected in these forward-looking statements.
These risks and uncertainties include, among others, the failure of CF gene
sequencing to produce diagnostic results as anticipated, the inability for
physicians to identify a greater number of patients impacted by
CFTR-related diseases as expected notwithstanding physicians' access to CF
gene sequencing, the continued availability of CF gene sequencing resulting
from the lack of commercial acceptance of CF gene sequencing, including the
acceptance of the tests at price levels that are economically viable for
Genzyme Genetics, and the risks and uncertainties described in reports
filed by Genzyme with the Securities and Exchange Commission under the
Securities Exchange Act of 1934, as amended, including without limitation
the information under the heading "Factors Affecting Future Operating
Results" in the Management's Discussion and Analysis of Financial Condition
and Results of Operations section of the Genzyme Quarterly Report on Form
10-Q for the quarter ending June 30, 2006. Genzyme cautions investors not
to place substantial reliance on the forward- looking statements contained
in this press release. These statements speak only as of the date of this
press release, and Genzyme undertakes no obligation to update or revise the
statements.
Genzyme(R) is a registered trademark and CFplus(TM) is a trademark of
Genzyme Corporation. All rights reserved.
Genzyme Corporation
http://www.genzyme.com
Genzyme lanseazã noi fibroza chistica de gene succesive de test - Genzyme Launches New Cystic Fibrosis Gene Sequencing Test - articole medicale engleza - startsanatate