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ACOG Issues Favorable Opinion for Non-invasive Prenatal Test Makers

NEW YORK (GenomeWeb News) – The American College of Obstetricians and Gynecologists has issued an opinion that non-invasive prenatal testing using cell-free fetal DNA can be offered to patients at increased risk of aneuploidy — a decision that is favorable to firms such as Sequenom, Ariosa Diagnostics, and Verinata Health.

The recommendation was made jointly by the ACOG Committee on Genetics and the Society for Maternal-Fetal Medicine Publications Committee.

ACOG defined increased-risk patients as "women aged 35 years or older, fetuses with ultrasonographic findings that indicate an increased risk of aneuploidy, women with a history of a child affected with a trisomy, or a parent carrying a balanced robertsonian translocation with increased risk of trisomy 13 or trisomy 21."

However, ACOG said that cell-free fetal DNA testing should not be part of routine prenatal laboratory assessment, and it should be an informed patient choice after pretest counseling. It also shouldn't be offered to low-risk women or women with multiple gestations because the technology hasn't been sufficiently evaluated in these groups, said ACOG.

In the opinion, ACOG noted validated technologies using massively parallel genomic sequencing to accurately detect trisomy 13, 18, and 21. Though it didn't name any of the firms that provide tests based on sequencing technologies, Sequenom, Ariosa and Verinata are among a handful of firms that have developed or are developing such non-invasive genomic tests.

Sequenom began selling its MaterniT21 Plus laboratory-developed test for detecting trisomy 21, 18, and 13 a year ago. The firm's CEO, Harry Hixson, said in a recent conference call that Sequenom's lab has reached a 90,000 annualized test volume run rate.

Verinata launched its test, called verify, in March, and Ariosa launched its test, called Harmony, in May through a partnership with Laboratory Corporation of America.

"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," Allan Bombard, Sequenom's chief medical officer, said in a statement. "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."

Several Wall Street analysts that cover Sequenom weighed in today, saying that the ACOG opinion is a positive development for the firm.

"[T]he recommendation should carry weight with payors, many of which we believe are considering national coverage decisions that could be swayed by these types of society recommendations or opinions," William Blair analyst Brian Weinstein wrote in a note this morning.

"Overall, the opinion is positive for developers of Trisomy 21 tests and references both [Sequenom] and competitors, Ariosa Diagnostics and Verinata Health," said Oppenheimer analyst David Ferreiro. "We believe the ACOG opinion should aid [Sequenom] with MaterniT21 adoption and payor discussions."

In Wednesday morning trade on the Nasdaq, shares of Sequenom were up 8 percent at $4.

Ariosa and Verinata are privately held.