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The page below is a sample from the LabCE course Advances in Noninvasive Prenatal Testing For Down Syndrome and other Trisomies. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Recommendations By Other Organizations

The California Technology Assessment Forum (CTAF) issued an independent evaluation of the cfDNA technology used for the assessment of fetal aneuploidy in high-risk women. The assessment concluded that the cfDNA technology is promising and has a high sensitivity and specificity for evaluation of fetal aneuploidy in high-risk women. Initially in October 2012 (and continuing in 2018), CTAF currently supports NIPT as an option for patients whose pregnancies are considered to be at an increased risk for certain chromosome abnormalities. The recommendation was made by CTAF based on the following criteria:
  1. The technology must have final approval from the appropriate government regulatory bodies.
  2. The scientific evidence must permit conclusions concerning the effectiveness of the technology regarding health outcomes.
  3. The technology must improve net health outcomes.
  4. The technology must be as beneficial as any established alternative(s).
  5. The improvement must be attainable outside the investigational setting.
In addition, the National Society of Genetic Counselors (NSGC) issued a position paper indicating support for the use of NIPT as an option for patients whose pregnancies are considered to be at an increased risk for certain chromosome abnormalities. NSGC emphasizes that NIPT only be offered if there is an informed patient consent, patient education, and counseling provided by a certified genetic counselor. In addition, patients with abnormal NIPT results should receive genetic counseling and be given the option of standard confirmatory diagnostic testing.
Reference links:
CTAF's FETAL ANEUPLOIDY DETECTION BY MATERNAL PLASMA DNA SEQUENCING, PART 2, A Technology Assessment. Available at: http://icer-review.org/wp-content/uploads/2016/01/121017_draft_fetal.pdf. Accessed June 13, 2018.
NSGC 2018 position statement on Prenatal Cell-Free DNA Screening. Available at: ttps://www.nsgc.org/p/bl/et/blogaid=805. Accessed June 13, 218.