WASHINGTON, Jan. 4, 2017 /PRNewswire/ -- Today, five leading
genetic testing companies in the U.S. are coming together to launch
the Coalition for Access to Prenatal Screening (CAPS). This new
organization will work to improve access to state-of-the-art
prenatal screening using cell-free DNA (cfDNA)-based noninvasive
prenatal testing (NIPT). The coalition is comprised of: Illumina,
Inc. (NASDAQ: ILMN); Counsyl, Inc.; Progenity, Inc.; Natera, Inc.
(NASDAQ: NTRA); and Laboratory Corporation of America® Holdings
(LabCorp®) (NYSE:LH) through its Integrated Genetics specialty
laboratory.
CAPS and its member companies are working together to promote
public awareness about the value of cfDNA-based NIPT and to
advocate for the highest standards of quality, service and
education. CAPS will work to encourage appropriate legislative
measures and reimbursement coverage policy changes for this
medically actionable testing service, which has the potential to
improve personalized patient care.
NIPT represents a major advance in the screening for fetal
chromosomal aneuploidies through the analysis of millions of cfDNA
fragments in the blood of a pregnant woman. Chromosomal
aneuploidies are characterized by an abnormal number of
chromosomes, which may cause genetic disorders in a newborn baby,
including some birth defects. Prenatal screening for chromosomal
aneuploidies using analysis of serum proteins has been the standard
of care for decades. However, cfDNA-based NIPT is becoming the
preferred method of prenatal screening for many healthcare
providers and patients since its introduction to clinical practice
in 2011.
The high sensitivity and specificity, and low failure rate, of
cfDNA-based NIPT result in fewer women undergoing invasive testing
procedures. Although all positive prenatal screening results should
be confirmed with diagnostic testing by chorionic villus sampling
(CVS) or amniocentesis, cfDNA-based NIPT correctly identifies a
higher proportion of pregnancies affected by chromosomal
aneuploidies, including Trisomy 21/Down syndrome, Trisomy
18/Edwards syndrome, and Trisomy 13/Patau syndrome, compared to
serum protein based screening options.
Extensive data have been published in peer-reviewed literature
that establish the performance of cfDNA-based NIPT as a powerful
screening tool for fetal chromosomal aneuploidies.1-5 In
addition to having a significantly higher detection rate,
cfDNA-based NIPT can simultaneously test for a larger number of
specific chromosomal aneuploidies than traditional serum screening
methods. Furthermore, the markedly lower false positive rates of
cfDNA-based NIPT provide significantly improved positive predictive
values compared to traditional screening tests.5 NIPT
can be used as early as 9 to 10 weeks into the pregnancy.
Numerous professional organizations, including the American
Congress of Obstetricians and Gynecologists (ACOG), the Society for
Maternal-Fetal Medicine (SMFM), the International Society for
Prenatal Diagnosis (ISPD), the American College of Medical Genetics
and Genomics (ACMG), and the National Society of Genetic Counselors
(NSGC) have recognized cfDNA-based NIPT as a screening option for
all pregnancies, given appropriate patient counseling regarding the
performance, risks and benefits of such testing.
"As leading providers of cfDNA-based NIPT, CAPS members are
working together towards the common goal of ensuring that this
innovative and highly accurate screening method is easily
accessible to all pregnant women who choose to pursue aneuploidy
screening, regardless of their risk factors, income, age or
geographic location," said Arnold W.
Cohen, M.D., Chairman Emeritus of the Department of
Obstetrics and Gynecology at the Einstein Healthcare Network, and
Chairman of the CAPS Clinical Advisory Board. "We recognize the
importance of providing reliable and useful information about
cfDNA-based NIPT to patients, healthcare providers, and public
and private insurers."
CAPS is assembling a clinical advisory board under the
leadership of Dr. Cohen, which will provide an independent medical
perspective. The composition of the board will be announced during
the first half of 2017.
Click here for more information on CAPS.
Contact
info@capsprenatal.com
1. McCullough R. et al. (2014) Non-Invasive Prenatal
Chromosomal Aneuploidy Testing - Clinical Experience: 100,000
Clinical Samples. PLoS ONE 9(10): e109173.
2. Taneja, P. et al. (2016) Noninvasive prenatal testing in
the general obstetric population: clinical performance and
counseling considerations in over 85 000 cases . Prenatal
Diagnosis 36(3), 237–243.
3. Dar P. et al. (2014) Clinical experience and follow-up with
large scale single-nucleotide polymorphism—based noninvasive
prenatal aneuploidy testing. Am J Obstet Gynecol 211:527.e1-17.
4. Mackie F. et al. (2016) The accuracy of cell-free fetal
DNA-based non-invasive prenatal testing in singleton pregnancies: a
systematic review and bivariate meta-analysis. BJOG DOI:
10.1111/1471-0528.14050.
5. Norton M et al (2015) Cell-free DNA Analysis for Noninvasive
Examination of Trisomy N Engl J Med 372:1589-97.
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SOURCE Coalition for Access to Prenatal Screening (CAPS)