Harmony Prenatal Test, a New Simpler, Cheaper Screening Tool for Fetal Trisomies

Harmony Prenatal Test, a New Simpler, Cheaper Screening Tool for Fetal Trisomies

An advanced blood test to detect common fetal trisomies at 10 weeks gestational age or later

The Harmony Prenatal Test analyzes the relative number of chromosomes in maternal blood to provide an objective, individualized patient result with high sensitivity and specificity. 1-3

atory

Safety

Non-invasive testing poses little risk to pregnant women

Standard blood draw

No risk to the fetus

Accuracy

Highly accurate detection of common fetal trisomies 4

Extremely low false positive rate 4

Individualized results on trisomy risk for each patient

San Jose, Calif., May 7, 2012 – Ariosa Diagnostics, a molecular diagnostics company today

announced that the Harmony™ Prenatal Test will be available in the United States and Canada through

Laboratory Corporation of America® Holdings (LabCorp®) and Integrated Genetics, a member of

LabCorp’s Specialty Testing Group. Harmony represents an innovative non-invasive test for detection

of common fetal trisomies utilizing a directed approach to analyze cell-free DNA (cfDNA) in maternal

blood. The Harmony Prenatal Test is currently available in selected locations and will be broadly

available next month.

“Ariosa Diagnostics is very excited to announce the official launch of the Harmony Prenatal Test and

the agreement with LabCorp, which helps us deliver on the promise of bringing an affordable and

accessible prenatal testing option to pregnant women and their physicians,” said Ken Song, MD, chief

executive officer at Ariosa Diagnostics. “With enhanced test performance and simplicity, the Harmony

Prenatal Test can be reliably incorporated into the management of pregnancies.”

The Harmony Prenatal Test, which detects common fetal trisomies such as Trisomy 21 (associated

with Down syndrome), will be offered through LabCorp and will be available at its 1,000+ patient

service centers. The test is performed using a simple maternal blood draw taken at a doctor’s office or

patient service center, and provides the safety of screening tests with accuracy approaching that of

invasive testing for common fetal trisomies. The test is available to pregnant women of at least 10

weeks gestational age with a single fetus conceived without the use of an egg donor.

“We are pleased to be able to offer this novel, non-invasive prenatal test,” indicated Mark Brecher, MD,

LabCorp’s chief medical officer. “Ariosa Diagnostics’ Harmony Prenatal Test adds another option to

LabCorp’s comprehensive prenatal testing menu.”

“The Harmony Prenatal Test is an affordable, high-quality test that provides a new choice for women,”

said Dr. Song. “Together with LabCorp, we are committed to ensuring that the latest advances in

prenatal testing are accessible to all healthcare providers and women.”

About Ariosa Diagnostics (formerly Aria Diagnostics)

Ariosa Diagnostics, Inc. is a molecular diagnostics company committed to providing safe, highly

accurate and affordable prenatal tests for maternal and fetal health. Led by an experienced team,

Ariosa is using its proprietary technology to perform a directed analysis of cell-free DNA in blood.

Ariosa’s simple blood test equips pregnant women and their healthcare providers with reliable

information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company began operations in 2010 and is headquartered in San Jose, Calif. For more information,

visit www.ariosadx.com.

*Integrated Genetics is a business unit of Esoterix Genetic Laboratories, LLC, a wholly-owned subsidiary of

Laboratory Corporation of America Holdings.

Ariosa Diagnostics (San Jose, California) is releasing in the U.S. and Canada its Harmony Prenatal Test for detecting fetal trisomies in maternal blood. To be distributed through Laboratory Corporation of America (LabCorp), the test analyzes cell-free DNA (cfDNA), which are free floating DNA fragments, some of which that are in the mother’s blood come from the fetus.

Harmony utilizes directed DNA analysis, which is cheaper and more precise than random sequencing, aka shotgun sequencing, to spot aneuploid chromosomes.

From the announcement:

The Harmony Prenatal Test, which detects common fetal trisomies such as Trisomy 21 (associated with Down syndrome), will be offered through LabCorp and will be available at its 1,000+ patient service centers. The test is performed using a simple maternal blood draw taken at a doctor’s office or patient service center, and provides the safety of screening tests with accuracy approaching that of invasive testing for common fetal trisomies. The test is available to pregnant women of at least 10 weeks gestational age with a single fetus conceived without the use of an egg donor.

Source : http://www.ariosadx.com/benefits-of-harmony-test/

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