PerkinElmer, Verinata Health Collaborate on Prenatal Down Syndrome Test

The medical device and pharmaceutical product firms are looking to expand access to a non-invasive test designed for high-risk pregnancies.

PerkinElmer, Inc. and Verinata Health, Inc., today announced a strategic agreement for expanding access to Verinata’s verifi® test, the most comprehensive non-invasive prenatal test (NIPT) currently available for high-risk pregnancies. The verifi® test, which is performed at Verinata’s CLIA-certified, California laboratory, uses a single maternal blood draw as early as 10 weeks of pregnancy to detect multiple fetal chromosomal aneuploidies. Chromosomal aneuploidy is an abnormal number of chromosomes.

Under the terms of the collaboration agreement, PerkinElmer will serve as an exclusive Verinata Health commercial partner in the joint sales and marketing of the verifi® test in the United States. The collaboration consolidates and streamlines delivery of prenatal testing options due to the combination of PerkinElmer’s extensive prenatal testing menu with Verinata’s proprietary technologies for the early, non-invasive identification of specific fetal chromosomal aneuploidies.

“PerkinElmer has a strong history and commitment to bring innovative offerings that are dedicated to maternal and fetal health, to physicians and patients. Integrating Verinata’s non-invasive prenatal test with PerkinElmer’s existing solutions ensures that physicians and patients have early access to the most advanced testing solutions to help protect the health of mothers and babies and we look forward to working with Illumina,” said Robert Friel, Chairman and Chief Executive Officer of PerkinElmer.

In December 2012, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine issued a joint Committee Opinion stating that NIPT is one option that can be used as a primary or secondary screening test for pregnancies with an increased risk for aneuploidy. This includes women who will be 35 years of age or older at delivery, women with a prior personal or family history of chromosome abnormalities, pregnancies that have received abnormal biochemical screening results, and pregnancies showing ultrasound abnormalities. Further asserting the importance of screening, this new opinion follows ACOG’s Practice Guidelines in 2007 which recommended that the option of screening and invasive diagnostic testing for aneuploidy be offered to all pregnant women, regardless of age.

Highly accurate biochemical screening results can be received as early as 11 weeks gestation, through the current PerkinElmer NTD Labs offering for Down syndrome and other chromosomal abnormalities. The verifi® prenatal test can be considered for women who have received high risk first trimester screening results at PerkinElmer’s NTD Labs early in the first trimester of pregnancy.

“Given our growing success with the verifi® prenatal test, we are excited that PerkinElmer has chosen our advanced technology as their NIPT offering,” said Jeff Bird, M.D., Chief Executive Officer and Executive Chairman at Verinata. “Collaborating with PerkinElmer provides a great opportunity to not only offer expectant mothers greater access to complete high quality screening and diagnostic tests, but to also extend the verifi prenatal test to the over 160 million people who are currently part of PerkinElmer’s contracted managed care network.”

About PerkinElmer

PerkinElmer, Inc. is a global leader focused on improving the health and safety of people and the environment. The company reported revenue of approximately $1.9 billion in 2011, has about 7,400 employees serving customers in more than 150 countries, and is a component of the S&P 500 Index. Additional information is available through 1-877-PKI-NYSE, or at www.perkinelmer.com.
 
About the verifi® prenatal test
 
The verifi® prenatal test is a blood test that analyzes genetic material (or DNA) naturally found in a pregnant woman’s blood to detect the most common fetal chromosome abnormalities. When directed by a physician, the verifi® test can be offered to pregnant women of at least 10 weeks gestation at high risk of carrying a fetus with a genetic abnormality. For more information on the verifi® test, please contact Verinata Health’s Client Services at 1-855-266-6563 (BMOMKND).
 
About Verinata Health
 
Verinata Health, Inc. is driven by a sole, extraordinary purpose – maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today’s multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. We support national guidelines and the recent American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine Committee Opinion recommending cell-free DNA prenatal testing is one option that can be used as a primary or secondary screening test in women at increased risk of aneuploidy. We believe women who desire such testing should be offered a single blood draw test with a definitive result. 
 
Source: Verinata Health via Business Wire
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