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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www.clinicalomics.com January/February 2017 Clinical OMICs 17 risk," says Kimberly Martin, M.D., senior global medical director for women's health with Natera. "But we also knew that the likelihood one of those women was actually carrying an affected fetus was less than 5%. So, most of those women came back for more testing, very nervous, and 95% were carrying a healthy fetus." By contrast, NIPT identifies less than 1% of women as high risk, and of those 50% have an affected fetus, notes Dr. Martin, who practiced for more than 20 years as an OB/GYN and is also a licensed clinical geneticist. It is this quantum leap in accu- racy that has so many excited about the important role NIPT can play in improving detection and eliminating unnecessary, risky, and costly invasive procedures. But in the medical com- munity, change often comes slowly, and CAPS' first priority to increase adoption rates is to provide solid edu- cation and data detailing the improve- ment in prenatal care quality that NIPT can provide. "Showing how this technology per- forms in the context of the current standard of care with the clinicians is a big activity in terms of how many patients OB/GYNs are treating every day," notes Jeff Hawkins, VP and gen- eral manager of reproductive genetic health at Illumina. "The current stan- dard of care is something that has been ingrained for decades, and mov- ing clinicians from something they are very comfortable with to something new is a big effort." Despite care guidelines on patient counseling for chromosomal abnor- malities that predate the availability of NIPT, Dr. Martin believes CAPS can play a vital role in helping obste- tricians meet this need. "I think what has happened is NIPT has unmasked the fact that we have not done a good job to date of training obstetrical care providers to have these conversations with their patients, in concise and effective ways," she says. CAPS, however, won't focus solely on physicians. It will take a broader approach to education about the tests; understanding that patients, govern- mental agencies, and private payers also play their own part in expanding the use of NIPT. "It doesn't matter who you are. Whether you are a clinician, a patient, or a medical director at an insurance company, we believe they will all ben- efit from greater educational aware- ness in this area," Hawkins notes. Dr. Martin has seen encouraging signs recently that some private pay- ers understand NIPT has benefits for all women, not just those considered high risk of having babies with chro- mosomal abnormalities. Within the past year and a half, major insurers CIGNA, Anthem Blue Cross, and other blues plans have added coverage of the tests for all women, not just those who are considered at higher risk. "The data is overwhelming," Dr. Martin concludes. "The NEXT study by Mary Norton in [The New England Journal of Medicine] clearly showed the performance enhancements of NIPT for women of all ages. I think CAPS can use this information to help push the change a little more quickly." Scientists at NIPT company Natera, and others in CAPS, seek to build upon the impressive early success of the tests to make them more widely used. Next-generation sequencing powers noninvasive prenatal testing. Natera Natera

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