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NIPT for laboratories

 

Non-invasive prenatal testing (NIPT) uses cell-free DNA (cfDNA) in mother’s blood to evaluate possible chromosomal conditions in a pregnancy and can be performed as early as 10 weeks of pregnancy using a single blood draw.

Roche offers the Harmony® prenatal test, with a focused and clinically-relevant menu that screens for trisomy 21, trisomy 18, and trisomy 13. Additional menu options include monosomy X, 22q11.2 microdeletion, other sex chromosome aneuploidies, and fetal sex.

The Harmony test has been used to screen over two million pregnancies1 and is trusted by patients, clinicians, and labs worldwide. Backed by the commitment and quality of Roche Diagnostics, the Harmony test is an opportunity to maximize your offering in the NIPT market.

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Why NIPT?

 

cfDNA-based NIPT has been recognized as the most sensitive and specific screening option for trisomy 21, trisomy 18, and trisomy 13.2 It also has the added benefit of being available during the first trimester of pregnancy.

Professional societies such as the Society for Maternal and Fetal Medicine and American College of Obstetrics and Gynecology state that cfDNA testing should be discussed and offered to all pregnant individuals.2

Additionally, the International Society for Prenatal Diagnosis (ISPD) considers NIPT as appropriate to be offered to all pregnant women as a primary screening test.3

Why Nipt
First trimester screening comparison

Because it has been shown to reduce the number of unnecessary invasive tests and diagnostic procedure-related complications by over 90% while resulting in an increased detection of trisomies compared to traditional first trimester screening, NIPT is being increasingly reimbursed by payers.1,4,5

References:

  1. Data on file.
  2. ACOG Practice Bulletin, Number 226. Obstet Gynecol. 2020 Oct;136(4):e48-e69.
  3. Benn et al. Prenat Diagn. 2015; 35: 725–734.
  4. Kostenko E et al. Fetal Diagn Ther. 2018 Aug 21:1-11
  5. Neyt et al. BMJ Open. 2014; 4(11): e005922.