By Nonie Arora
The students explained to government officials that noninvasive prenatal testing requires only a blood sample from a pregnant woman. Current tests, such as amniocentesis, involve extracting cells from the placenta or fluid surrounding the fetus.
Instead, with the new technology labs genetically sequence fetal, cell-free DNA from in the mother’s blood to test for certain disorders. The method can detect when a fetus does not have the normal number of chromosomes. Specifically, it can detect abnormalities in chromosomes 13, 18 and 21, which can lead to disorders such as Down’s Syndrome.
The technology can also identify some fetal, sex-linked disorders and certain single-gene mutations. It is reliable after seven weeks of pregnancy, the students reported.
The presentation was a final project of the Genome Sciences & Policy capstone course, which leads to students earning a certificate in the field.
The students said Duke geneticist Hunt Willard and Dr. Robert Cook-Deegan, the professors for the course, chose noninvasive prenatal testing as the capstone topic because it is a new and rapidly growing field.
“Our professors wanted us to have a feel for what it’s like to research technology while it’s happening, while decisions are being made about whether it’s accurate and reliable,” said Biqi Zhang, one of the students in the class.
To investigate the scientific basis for noninvasive prenatal testing, its challenges, the active stakeholders and associated ethical considerations, these students interviewed individuals involved with different aspects of the technology.
“We had to go out and connect with many well-established professionals in related fields. It was exciting to develop skills that you normally don’t inside the classroom,” said Selina Chen, another student in the course.
“We had the opportunity to contact researchers and CEOs of companies to gain a comprehensive understanding of the technology,” Zhang added.
The students said that the technology can and will fundamentally alter prenatal medicine. Throughout the semester, they have gained a nuanced understanding of its complexities and the viewpoints of many different stakeholders involved, from technology startup CEOs to primary care physicians.
“It was most exciting being able to go into the real world and see how this technology is being clinically implemented,” said capstone student Ryan Gimple.
“Traveling to the FDA was definitely nerve-wracking, for me at least,” capstone student Hiruni Amarasekara said. “We wanted to present a comprehensive report of the technology so that they could use this information in their decision making process on whether to recommend the test in the future. It was hard to tell what the FDA was thinking as we were presenting our information.”
The FDA has not yet stated a position on use of noninvasive prenatal testing.