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Expectant parents always wonder if it's a boy or a girl, and if they don't wonder, they will be asked. Recently a biotech company started selling a test that it says uses just a drop of blood to reveal the sex of a child as early as five weeks into a pregnancy, earlier than a sonogram. The test's marketer says thousands of women have bought it, but NPR's Nell Boyce reports that customers and scientists are now raising questions about it.

NELL BOYCE reporting:

The Baby Gender Mentor test made its first big splash in June on NBC's "Today" show.

(Soundbite of "Today" show theme music)

BOYCE: All an expectant mom has to do is prick her finger and send a few drops of blood to Accugen bio lab in Lowell, Massachusetts. The test costs 275 bucks. NBC's Robert Bozell explained that the test detects fetal DNA in a mother's blood.

(Soundbite of "Today")

Mr. ROBERT BOZELL (NBC): The company looks for traces of a Y or male chromosome. If one is there, it is a boy. If there is no Y chromosome, it is a girl.

BOYCE: Host Katie Couric asked how accurate is this. Her guest was Sherry Bonelli, who has a Web site called pregnancystore.com. It's the exclusive retailer for the test.

(Soundbite of "Today")

Ms. SHERRY BONELLI (pregnancystore.com): Well, let's just put it this way. The lab is saying it's 99.9 percent. They've actually followed more than 2,000 women throughout their pregnancy and they've never been wrong.

BOYCE: Soon the story was everywhere, from The Boston Globe to CNN. Now for years scientists have worked to reliably detect fetal DNA in a mother's blood. The idea is to some day have a less risky test than amniocenteses but detecting fetal DNA isn't easy. So NPR asked Bonelli how Accugen had achieved its breakthrough.

Ms. BONELLI: It's proprietary patent-pending technology. I mean, they've come up with a totally revolutionary way of identifying it, something totally different than anything else that's out there.

BOYCE: Well, not totally different. Accugen's Web site cites the work of Faraday Bishoff(ph). She's a scientist at Baylor College of Medicine, and she's done the only published study on finding out gender using just a drop of a mother's blood. She says you can get accurate results when a pregnancy is well under way, but Bishoff is very skeptical about near perfect accuracy at just five weeks.

Ms. FARADAY BISHOFF (Scientist, Baylor College of Medicine): There's DNA at earlier gestation. So the less fetal DNA you have, the more difficult it is to detect those sequences.

BOYCE: NPR repeatedly asked Accugen about its test. We called its president, Chang Ning Wang(ph), but the return call came from Shaw Linn(ph). He says he's an old friend who's helping Wang out with publicity. Linn wanted written questions, so we sent some. Two weeks later, Linn sent an e-mail, read here by an actor.

Unidentified Man #1: (As Linn) Dr. Wang has just returned and has decided to defer all his interviews regarding Baby Gender Mentor product and service for one more year when the results of actual births compared to the results provided by Baby Gender Mentor should answer any concern of the accuracy of the test.

BOYCE: But didn't Accugen already have this kind of data? NPR asked and got this e-mail directly from Wang.

Unidentified Man #2: (As Wang) In the eyes of skepticism, voice and words are redundant; time will tell.

BOYCE: Some of Accugen's customers don't believe it. Danielle Hardy(ph) lives near Louisville, Kentucky. She's got two young boys and is pregnant again. Her Accugen test said she was having another boy.

Ms. DANIELLE HARDY: We named this baby. We named him John Riley(ph). We discussed it with my three-year-old. He became a part of our family.

BOYCE: But when she went for a sonogram, it said she was having a girl.

Ms. HARDY: I mean, I had this baby in my tummy and his name's John Riley, and he's a part of me and he's real and we're having this baby boy. I'm sure this is a mistake.

BOYCE: So Accugen agreed to re-test Hardy. Again, the test said boy, and the company added another test. This time, looking for girl DNA. Now scientific experts say this is much more difficult because girl DNA would be so similar to her mother's. But the company says it can do it. And it said Hardy's blood had no girl DNA. Hardy began to panic and she rushed to her doctor, Matthew McDanald(ph).

Dr. MATTHEW McDANALD: Here I am, I'm having a conversation with a patient who's distraught about the development of her healthy child, trying to consider test results I know nothing about.

BOYCE: Another expectant mother is Heather Scott(ph) who lives near St. Louis. Last month, Accugen told her that she had twins.

Ms. HEATHER SCOTT: I called the 1 (800) number and I said, `Hey, I just got my results. And you're saying that it's twins, a boy and a girl. How accurate is that?' And the gentleman that I spoke with says, `Oh, we're 99.9 percent sure.'

BOYCE: But then she went for a sonogram.

Ms. SCOTT: And I'm laying there and the ultrasound tech says, `Well, we only see one baby.'

BOYCE: Accugen told Scott that she had what is called a vanishing twin, a twin that died and got reabsorbed. That does occasionally happen. But Scott says her doctor didn't see any sign of it. These anecdotes don't prove anything. But with the company not talking, the stories worry Diana Bianchi.

Ms. DIANA BIANCHI (Fetal DNA Expert, Tufts University): I think we need to be concerned whether the test is accurate or not. I think it's caveat emptor. You know, let the buyer beware.

BOYCE: Meanwhile, Sherry Bonelli suggests that skeptical scientists may just be jealous of Accugen.

Ms. BONELLI: Because they've developed something that other technology companies haven't come up with doesn't necessarily mean that it's false.

BOYCE: But they've offered no evidence that it's true.

Ms. BONELLI: They've offered no evidence that it's not true.

BOYCE: What actual scientific evidence can the lab offer?

Ms. BONELLI: When they're ready to release that information, they will release it.

BOYCE: Have you seen the information?

Ms. BONELLI: No. It's proprietary.

BOYCE: And you're comfortable selling this test, not having seen that evidence?

Ms. BONELLI: Absolutely.

BOYCE: Bonelli says she's never visited Accugen. The company is in a long beige building made of cinder blocks. The sign at the road has peeling paint and it doesn't say Accugen. It lists a Hindu temple. Next door to the temple is a small office labeled Biotronics. That's another company run by Accugen's president Chang Ning Wang. When I visited this week, a young man wearing latex gloves sat in the foyer at a computer. He said Wang wasn't there.

Is there someone else at the company who could help me?

Unidentified Man #3: Can you hold on one second?

BOYCE: Sure. Thank you.

Eventually he returned and politely said that nobody would talk to me.

Who does the company have to talk to? Well, the Food and Drug Administration doesn't regulate this kind of non-medical test, even though women who want a baby of a certain gender might use its results to decide whether or not to have an abortion. The lack of information leaves some women in limbo. Danielle Hardy of Louisville says she's going to spend the next three months agonizing over the thought that something might be wrong with her baby girl.

Ms. HARDY: It still just hovers over me like this black cloud. It's just really dampened the fun of being pregnant.

BOYCE: She says her uncertainty is ironic. She took the Accugen test, after all, to get an answer as early as possible.

Nell Boyce, NPR News.

INSKEEP: To learn more about Accugen and its test, go to npr.org.

This is NPR News.

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