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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.) 2 3