The troubled diagnostic company Sequenom launched a test for determining the sex of a fetus by analyzing the mother's blood.

The early-detection test could help expectant mothers learn the sex of their fetus in the first trimester, according to the San Diego-based company, weeks before an ultrasound would reveal sexual characteristics. It could also provide good news for the biotech firm that was rocked by scandal last year as much of its executive staff resigned or were forced out amid revelations of data mishandling of a controversial Down syndrome maternal blood test.

Called SensiGene Fetal (XY), the fetal gender test works by detecting free circulating fetal DNA in the mother's bloodstream. The test sifts for evidence of the male Y chromosome, which the mother wouldn't have.

"You're basically looking for male-specific targets on the Y chromosome," Ian Clements, a spokesman for Sequenom, tells DOTmed News. "There are some other kinds of quality control metrics in there, too in terms of fetal identifiers, making sure you know the difference between maternal and female fetal DNA," he adds. "So when you have female DNA, you know you're not looking at the mother's, you're looking at baby's DNA."

According to Sequenom, clinical tests, which are not yet published, suggest a 98.6 percent accuracy in correctly identifying fetus gender. In the validation study, which looked at a couple of hundred samples, the average age of gender prediction was 12 1/2 weeks, six weeks earlier than ultrasound detection, the standard method, says Clements.

MARKET PROMISE

Sequenom hopes the test will be popular. Their in-house survey of about 400 expectant mothers suggests that around 80 percent would like to learn the sex of their unborn children if it were safe, affordable and convenient. The primary reason, Sequenom says, is plain old curiosity.

"Why would you not do it?" Clements asks. "I think the overwhelming thing is, they just wanted to know."

According to the survey, the top reasons, besides the mother's curiosity, were the spouse's, and to help decide what color to paint the nursery.

Of course, there could be darker reasons. But Sequenom, which says it supports the American Congress of Gynecologists and Obstetricians' (ACOG) 2007 statement opposing sex-selective abortions, has made the testing available only through a physician's order, in the hopes of preventing such a practice.

"Actually having [the test] ordered by a physician I think allows for the right choices to be made between the physician and patient during the discussion of the care of that particular individual's pregnancy," Clements says.

Because it is not believed to address a medical need, the test would not be covered by insurance and expectant mothers would have to pay out of pocket -- $395 in the U.S. -- to have the blood sample sent to Sequenom's Grand Rapids, Mich. laboratory for analysis.

But Wall Street seems to agree that there could be enough women who want to do it. Sequenom's stock jumped an electric 16.4 percent to close at around $5.26 per share on Tuesday's announcement.

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