Harmony can be ordered for any patient as early as 10 weeks.

Patients are asking — and clinicians need to be equipped with the right knowledge. While traditional screening can miss as many as 15% of pregnancies with trisomy 21, Harmony’s DNA-based technology accurately identifies more than 99% of cases.1

The superior accuracy and low false-positive rate of Harmony compared to traditional screening tests may minimize anxiety and invasive procedures caused by false-positive results.2-4 Expecting parents will benefit from the knowledge Harmony provides and healthcare providers will appreciate the easy integration into routine protocols.

Three simple steps to accurate risk assessment:

baby

Order Harmony as early as 10 weeks gestation. A simple blood draw is all that is required.

test-tube

Send a blood sample for analysis using the Harmony kit.

calendar

Receive results within 5-7 days upon receipt of sample. Share with your patient and decide on next steps.

Note: Harmony is designed to assess risk for trisomy 21, 18, and 13 and sex chromosome aneuploidy only. It does not detect all genetic defects every problem that may occur in pregnancy.

Medical Societies Guidelines

Professional medical societies support offering aneuploidy screening, including cell-free DNA screening, to any pregnant women5-8 “

“ACMG recommends informing all pregnant women that NIPS is the most sensitive screening options for traditionally screened aneuploides…”

ACOG/SMFM Committee Opinion Number 640: “… any patient may choose cell-free DNA (cfDNA) analysis as a screening strategy for common aneuploidies regardless of her risk status…”

Reliable Results, Responsive Service.

If you are using the Harmony Prenatal Test and have questions or need assistance, please contact Client Services.

contact

sjc.affiliatesupport@roche.com
Toll-free: 1-855-927-4672
Fax: 877-927-6151

References: 1. ACOG Committee on Practice Bulletin No. 163. Obstet Gynecol May 2016. 2. Norton et al. N Engl J Med. 2015 Apr 23;372(17):1589-97. 3. Wax et al. J Clin Ultrasound. 2015 Jan;43(1):1-6. 4. Lou et al. Acta Obstet Gynecol Scand. 2015;94(1):15-27. 5. ACOG Committee on Practice Bulletin No. 77. Obstet Gynecol 2007;109:217-27.6. Committee on Genetics, Society for Maternal Fetal Medicine. Obstet Gynecol. 2015 Jun 29. [Epub ahead of print] 7. Benn P et al. http://www.ispdhome.org/public/news/2015/PositionStatementFinal04082015.pdf. 2015 Apr. 8. Gregg et al. Genetics in Medicine. 2016;1-10.

The Harmony Prenatal Test was developed by Ariosa Diagnostics, a CLIA-certified laboratory. As with other lab-developed tests, it has not been cleared or approved by the FDA and is not available for sale as an IVD in the US. Non-invasive prenatal testing (NIPT) based on cell-free DNA analysis is not diagnostic; results should be confirmed by diagnostic testing.

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