|
Automated GSP? Genetic Screening Processor enables
multi-analyte analysis, accelerates sample screening and
increases accuracy
WALTHAM, Mass.(BUSINESS WIRE)
Last sentence of release before boilerplate, URLshould read: http://las.perkinelmer.com/Catalog/FamilyPage.htm?CategoryID=GSP+-+Genetic+Screening+Processor
The corrected release reads:
PERKINELMER SECURES FDA 510K CLEARANCE FOR NEWBORN SCREENING PLATFORM
Automated GSP? Genetic Screening Processor enables
multi-analyte analysis, accelerates sample screening and
increases accuracy
PerkinElmer,
Inc., a global leader focused on the health and safety of people and
the environment, today announced that the Company has received 510K
clearance from the U.S. Food and Drug Administration for its GSP?
Genetic Screening Processor, which is used by public health
laboratories worldwide as part of newborn screening programs.
In newborn screening programs, infants are tested for a range of
genetic, metabolic or hematologic disorders. When identified within the
first few days of life, these disorders are often easily managed, but if
left untreated, could lead to serious illness or even death. The testing
process begins with the collection of a few drops of blood from a heel
prick.
The GSP system makes it much easier for labs to analyze newborn blood
samples by providing the capability to run more than one test at once on
very small samples. The GSP is an automated platform able to
quantitatively and qualitatively analyze blood spot samples for
irregularities associated with metabolic diseases that when detected
early, can often be easily treated. With multi-analyte analysis
capability and a two-fold capacity over prior systems, the GSP system
delivers increased efficiency and flexibility over other methods, while
reducing the risk of errors associated with manual processing of samples.
The GSP analyzer eliminates the need to analyze all samples in batches,
permitting specimens to be processed as they arrive in the laboratory.
This flexibility improves response time for delivering results to
physicians and parents and eases the challenge of sample workflow
management. Multi-analyte capability permits analysis for several
analytes simultaneously, preserving the small sample volume for a wider
range of analysis. The GSP Neonatal TSH assay is the first assay to
receive FDA clearance for the GSP instrument. Several additional newborn
screening assays are in development.
FDA approval of PerkinElmer's GSP system provides laboratories in the
U.S. with a next-generation system that can help address the staffing
and workflow needs of today's demanding environment,? said Ann-Christine
Sundell, president, Genetic Screening, PerkinElmer. This achievement
reflects our ongoing commitment, as the global leader in newborn
screening, to improving medical outcomes by developing the highest
quality newborn screening solutions.?
The GSP performs each stage of the assay process, from the retrieval of
the sample plate to sample measurement, and reporting of results in a
single platform. All-inclusive technology allows operational efficiency
by accelerating workflows and reducing hands-on time, which, when
combined with the availability of barcoding, reduces the risks of human
error.
The GSP analyzer is designed to be flexible and can be seamlessly
integrated into a range of lab operations. The processor will allow for
both multi-analyte screening as well as the ability to run traditional
immunoassays or enzymatic-assays, thus accommodating varying workflows.
Other design features that address common laboratory challenges include
the ability to continuously load samples, the refrigeration of onboard
reagents, and the integration of direct access to water and waste lines
to streamline processes and dedicated software.
For more information please visit http://las.perkinelmer.com/Catalog/FamilyPage.htm?CategoryID=GSP+-+Genetic+Screening+Processor
About PerkinElmer, Inc.
PerkinElmer, Inc. is a global leader focused on improving the health and
safety of people and the environment. The Company reported revenue of
approximately $2 billion in 2008, has around 8,500 employees serving
customers in more than 150 countries, and is a component of the S&P 500
Index. Additional information is available through www.perkinelmer.com
or 1-877-PKI-NYSE.
PerkinElmer Contact:
Henri Storm, +358-22-678-284
Henri.Storm@perkinelmer.com
or
Additional
media Contact:
Amy Speak, +1-617-897-8262
Amy.Speak@porternovelli.com
Source: PerkinElmer, Inc.
|
