Clinical OMICS

JAN-FEB 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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16 Clinical OMICs January/February 2017 www.clinicalomics.com Diagnostics Tip of the CAPS Genetic Testing Companies Form Coalition to Promote Noninvasive Prenatal Testing Chris Anderson, Editor in Chief A group of five leading genetic testing companies oper- ating in the noninvasive prenatal testing (NIPT) space has formed the Coalition for Access to Prenatal Screening (CAPS), with the goal of providing education about, and increase the use of, cell-free DNA (cfDNA)-based pregnancy screening tests. Founding mem- bers of CAPS are: Illumina, Counsyl, Progenity, Natera, and LabCorp (through its Integrated Genetics specialty laboratory). Launched in early January, the first mission of CAPS is to form a clinical advisory board comprising indepen- dent physicians, which will provide an independent med- ical perspective on the use and efficacy of the tests, and to help guide members on how to best provide education on the benefits of NIPT. The tests screen for chromosomal abnormalities in the fetus, including Down syndrome, trisomy 18, trisomy 13, sex chromo- some abnormalities, and others. "If you look at NIPT—it was introduced in 2011—it is one of the most rapidly adopted technologies for testing in medicine," says Arnold W. Cohen, M.D., chairman emeritus of the department of obstetrics and gynecology at the Ein- stein Healthcare Network, and chairman of the CAPS clini- cal advisory board. "In three or four short years, it became standard for women who were over 35, or have a history of having a baby with Down syndrome or an abnormal- ity on ultrasound, or a family history. We think it should be used for anyone who wants it, the way the testing was first approved for high-risk patients." Members of the new coalition tout the accuracy and specificity of the tests, which, as a result, have the potential to signifi- cantly reduce the need for more invasive testing meth- ods, such as amniocentesis and chorionic villus sampling (CVS), that pose some risk to the pregnancy. Starting in 2007, the Ameri- can Congress of Obstetricians and Gynecologists (ACOG) provided care guidance that obstetricians need to provide education and offer screening for chromosomal abnormalities to all pregnant women. At the time, however, even the best noninvasive testing methods had 5% false positive rates and specificity of only 80% to 90%. "That meant one in 20 women had to receive the scary phone call that her test had come back indicating a high 7activestudio / Getty Images

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