Download Non-Invasive DNA testing in Pregnancy .pub

December 2014
Non-Invasive DNA testing in Pregnancy
Harmony® Prenatal Test
The Allina Health System has selected the Harmony® Prenatal Test as
the standard for non-invasive pregnancy testing (NIPT). Harmony is
performed at Ariosa® Diagnostics, ariosadx.com. To reduce clinical
variation, and ensure that all Allina patients receive the highest quality of
care with the lowest out-of-pocket cost, the laboratory does not accept
orders or collect specimens for testing at competitor labs (MaterniT21®
and others).
What is the Harmony Prenatal Test?
The Harmony® Prenatal Test is a non-invasive screening risk
assessment performed on maternal blood from pregnant women with
singleton or twin pregnancies of 10 weeks or more. The test detects
most fetuses affected with the following common aneuploidies (Trisomy
13, Trisomy 18, Trisomy 21) and there is an option to screen for the
presence of a Y chromosome, or for aneuploidies of the X and Y
chromosomes. It is for the evaluation of at risk patients who would
otherwise require an amniocentesis. Harmony has a >99% detection
rate for T21 and T18. T13 detection is approximately 93%. However, this
is currently still a screen with false positives and false negatives; it is
NOT a diagnostic test.
Current available Harmony Panels:
There are three Harmony® Test Panels offered:
1. Harmony® (screen for Trisomies 21, 18, 13)
2. Harmony plus Y ® (also screens for presence of Y chromosome)
Harmony plus XY® (also screens for aneuploidies of XY
chromosomes)
Why was Harmony® chosen over other competing tests?
 Allina Health genetic counselors, obstetricians, and perinatologists participated in
the clinical validation studies for Harmony in high risk and low risk women. This
means that our clinicians have firsthand experience with how Harmony® performs
in patients who also had sequential screens, gold-standard amnioncentesis , and
were followed here for fetal outcomes.
 Unlike other available tests, Harmony® reduces false positives by incorporating the
fetal fraction of DNA in formula used for risk calculation and interpretation. False
positives are very distressing for patients and lead to unnecessary invasive testing.
 Compared to other available tests, Harmony has a high positive predictive value,
93%, for trisomy 21.
 Unlike competing laboratories, Ariosa Diagnostics is conservative in offering
additional evaluations that may not be clinically validated or actionable.
 Allina’s OB Geneticist and genetic counselors are not comfortable with
microdeletion evaluations offered by other laboratories, as the evaluations have not
been validated on patients with the actual deletions they provide risk assessment
for.
 The cost of Harmony® is lower than similar test panels and Ariosa accepts all
patient insurance including Medicaid with a limit on patient out-of-pocket expense.
How to order Harmony®
1. Obtain a kit from the lab. Complete all sections on the paper request form (shown
on next page) and indicate the desired Harmony Panel in section 5.
Note: This must be completed by the provider or nurse team.
2. The patient and ordering clinician must sign the form (sections 3 and 4).
3. In Excellian: Order LAB994 MSO and specify the Harmony test panel ordered on the
paper form (see paper form attached.)
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