Table 3:
Characteristics of the Panorama and Harmony Noninvasive Prenatal Tests
| Test Characteristic | Panorama Prenatal Test | Harmony Prenatal Test |
|---|---|---|
| Manufacturer | Natera | Ariosa Diagnostics (Roche) |
| Laboratory availability | LifeLabs | Dynacare |
| Pregnancy population | Can be performed in twin pregnancies, consanguineous couples, and singleton pregnancies conceived by in vitro fertilization, including egg-donor and surrogate pregnancies Should not be performed in people who have received a bone marrow transplant |
Can be performed in twin pregnancies, consanguineous couples, and singleton pregnancies conceived by in vitro fertilization, including egg-donor and surrogate pregnancies Should not be performed in people who have received a bone marrow or organ transplant, or in people who have metastatic cancer |
| Analysis method | Targeted approach Single nucleotide polymorphism |
Targeted approach Microarray-based digital analysis of selected regions (DANSR) |
| Sensitivity reported by manufacturer | Trisomy 21: >99.9% Trisomy 18: 98.2% Trisomy 13: >99% Monosomy X: 92.9% 22q11.2 deletion syndrome: 90% Microdeletion extended panel (1p36 deletion, 15q11–q13 deletions [Angelman syndrome and Prader-Willi syndrome], 5p deletion): 93.8% to >99% |
Trisomy 21: >99% Trisomy 18: 97.4% Trisomy 13: 93.8% Monosomy X: 94.3% |
| False-positive rate reported by manufacturera | Trisomy 21: 0% Trisomy 18: <0.1% Trisomy 13: 0% Monosomy X: <0.1% Each microdeletion syndrome: <1% |
Trisomy 21: <0.1% Trisomy 18: <0.1% Trisomy 13: <0.1% |
| Test timing | As early as 9 weeks of pregnancy | As early as 10 weeks of pregnancy |
| Time to result | Within 10 days | Within 10 business days |
| Out-of-pocket test costb | Trisomies 21, 18, and 13, and sex chromosome aneuploidies: $550 Plus 22q11.2 deletion: additional $195 Plus microdeletion extended panel: additional $245 |
Trisomies 21, 18, and 13, and sex chromosome aneuploidies: $495 Plus 22q11.2 deletion: additional $175 |
a
Systematic reviews suggest a higher false-positive rate than those reported by the manufacturers.16–19 The false-positive rate is also not equivalent to the positive predictive value, which is defined as the probability of a true positive given a positive test result.
b
Out-of-pocket test cost as of April 2018.