Innovative Cost-Effective Solution Provides Pregnant WomenWidespread
Access to Non-Invasive Prenatal Testing
WALTHAM, Mass.--(BUSINESS WIRE)--Nov. 26, 2018--
PerkinElmer,
Inc. (NYSE: PKI), a global leader committed to innovating for a
healthier world, today announced that its Vanadis®
NIPT system has obtained CE-IVD mark for commercialization and
distribution throughout Europe and other countries that accept CE
marking. This non-invasive test provides screening results for trisomy
21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau
syndrome). The Vanadis NIPT system has been validated in an external
clinical study conducted in France. The blinded study analyzed 80
samples from pregnancies affected by trisomy 21 and 670 samples from
unaffected pregnancies, classifying all cases correctly, with only one
sample failing to generate a result. In addition to trisomy 21,
PerkinElmer conducted clinical studies to demonstrate high sensitivity
and specificity for trisomies 18 and 13.
Generally, non-invasive prenatal testing (NIPT) analyzes cell-free DNA
(cfDNA) circulating in the maternal blood and has rapidly become the
standard follow-up procedure for women classified as high risk following
traditional prenatal screening. Measuring cfDNA from a standard blood
draw to detect common chromosomal trisomies has been demonstrated with
high sensitivity and specificity.
“NIPT has been previously limited by the complexity, cost and capacity
of existing commercially available technologies, which prevented many
laboratories and obstetricians from offering reliable, and
cost-effective solutions for aneuploidy screening,” said Olle Ericsson,
General Manager at Vanadis Diagnostics, a PerkinElmer company. “With our
Vanadis platform, we are taking the technical complexity out of NIPT
while breaking down the cost barriers. This will enable more women to
gain access to NIPT and improve the level of prenatal care on a global
level.”
Unlike existing NIPT technologies, which require more complex platforms
such as sequencing or microarrays, the Vanadis NIPT platform is the
first of its kind designed to simplify screening for trisomies 21, 18
and 13. The Y chromosome can be measured as an optional marker. This
cost-effective, high-throughput scalable platform measures fetal
chromosomal trisomies in maternal plasma by targeted fluorescent
labeling and counting specific cfDNA fragments—removing the costly and
data-intensive steps required for gene sequencing or microarray
solutions.
“The promising results we’ve seen lead us to believe that a broad range
of women throughout Europe and around the world now stand to benefit
significantly from being able to have NIPT as a key component of
prenatal care,” said Jérémie Gautier, head of the project management
team at CerbaXpert, which played a leading role in the evaluation study
in France.
PerkinElmer is also currently collaborating
with Women & Infants Hospital (WIH) of Rhode Island, a Care New England
hospital, in a clinical validation study to evaluate an innovative test
method using the VanadisNIPT system.* The VALUE (Validation
of a Lower Cost Aneuploidy Screen) study aims to test samples from
approximately 2,500 women, most from an average risk pregnancy
population, with additional high-risk cases added to determine
performance characteristics such as detection rates and false positive
rates.
“The Vanadis technology has the potential to bring cfDNA screening for
common trisomies to the general pregnancy population who cannot readily
access NIPT at this time due to the high cost of available tests,” said
Glenn Palomaki, PhD, Associate Director of the Division of Medical
Screening and Special Testing at WIH, and Professor, Department of
Pathology and Laboratory Medicine at the Warren Alpert Medical School of
Brown University. “This platform has the potential to be as efficient as
current next generation sequencing offerings—yet could be
cost-competitive with current first trimester combined screening.”
For more information on the Vanadis NIPT system, please visit: www.prenataltesting.perkinelmer.com/vanadis.
About PerkinElmer
PerkinElmer, Inc. is a global leader
committed to innovating for a healthier world. Our dedicated team of
about 11,000 employees worldwide is passionate about providing customers
with an unmatched experience as they help solve critical issues
especially impacting the diagnostics and discovery and analytical
solutions markets. Our innovative detection, imaging, informatics, and
service capabilities, combined with deep market knowledge and expertise,
help customers gain earlier and more accurate insights to improve lives
and the world around us. The Company reported revenue of approximately
$2.3 billion in 2017, serves customers in more than 150 countries, and
is a component of the S&P 500 Index. Additional information is available
through 1-877-PKI-NYSE, or at www.perkinelmer.com.
*PerkinElmer’s Vanadis NIPT system is not available for clinical use
in the United States.
Products may not be licensed in accordance with the laws in all
countries, such as the United States and Canada. Please check with your
local representative for availability.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181126005037/en/
Source: PerkinElmer, Inc.
PerkinElmer, Inc.
Brian Willinsky, +1-781-663-5728
brian.willinsky@perkinelmer.com