SAN DIEGO, Nov. 21, 2012 /PRNewswire/ --Sequenom, Inc. (SQNM), a life sciences company providing innovative diagnostic testing and genetic analysis solutions, today announced that the American College of Obstetricians and Gynecologists (ACOG) Committee on Genetics and the Society for Maternal-Fetal Medicine (SMFM) Publications Committee issued a joint Committee Opinion on November 20, 2012, recommending that cell-free fetal DNA testing be offered to patients at increased risk of aneuploidy. It can also be used as a follow-up test for women with a positive first-trimester or second-trimester screening test result.

Previously, the ACOG recommended that women, regardless of maternal age, be offered prenatal assessment for aneuploidy by screening or invasive prenatal diagnosis. The ACOG Committee on Genetics and the SMFM Publications Committee now recommend that women at increased risk of aneuploidy be offered cell-free fetal DNA as an option that can be used as a primary screening test based on the following indications:

The Committee Opinion also recommended that "cell-free fetal DNA testing should not be offered to low-risk women or women with multiple gestations because it has not been sufficiently evaluated in these groups." Further, the Committee Opinion stated that "pre-test counseling should be an informed patient choice after pre-test counseling and should not be part of routine prenatal laboratory assessment. A patient with a positive test result should be referred for genetic counseling and offered invasive prenatal diagnosis for confirmation of test results."

"The issuance of the ACOG/SMFM opinion on the use of cell-free fetal DNA testing represents a major step forward for the integration of this valuable technology into pregnancy care programs" said Allan Bombard, MD, Sequenom's Chief Medical Officer. "We fully support the indications for considering the use of cell-free fetal DNA outlined in the Committee Opinion and believe this will be a valuable tool to help guide physicians and their patients in the most appropriate prenatal care."

ACOG is the nation's leading group of physicians providing health care for women. The College strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women's health care.

SMFM is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine. The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods. It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.

The full text of the Committee Opinion can be found at: Noninvasive prenatal testing for fetal aneuploidy. Committee Opinion No. 545. American College of Obstetricians and Gynecologists. Obstet Gynecol 2012: 120:1532-4.

About the MaterniT21 PLUS Test

The MaterniT21 PLUS test analyzes the relative amount of 21, 18, 13 and Y chromosomal material in cell-free DNA. The test is intended for use in pregnant women at increased risk for fetal aneuploidy and can be used as early as 10 weeks gestation. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the United States. The MaterniT21 PLUS test is available exclusively through the Sequenom Center for Molecular Medicine (Sequenom CMM) as a testing service provided to physicians. To learn more about the test, please visit http://www.Sequenomcmm.com.

About Sequenom

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The American College of Obstetricians and Gynecologists Committee on Genetics and the Society for Maternal-Fetal ...

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