NEW YORK (CNN/Money) -
Amniocentesis, a common prenatal test that involves sticking a needle into the mother's womb, is dreaded by many because of its risk to the fetus, but a diagnostic company hopes to eliminate that risk by developing a urine test that would detect Down syndrome in fetuses.
Xenomics is working on a prenatal test that, if successful, would detect fetal DNA in a mother's urine. Xenomics (down $0.04 to $2.05, Research) CEO Randy White said this presents no risk to the mother or the fetus and would be conducted earlier in the pregnancy than amniocentesis. Also, the urine test would provide a more accurate read of fetal abnormalities than currently available blood tests, said White.
"At this day and age where we have professional women who are continuing to delay their pregnancies, this is a badly needed test," said White, referring to the increased risk of fetal Down syndrome in older mothers. "There is a bad, bad need for a test that is safe and effective and gives a definitive yes-no result."
If clinical tests are successful, Xenomics could submit its product to the Food and Drug Administration in 2007. The FDA could take six months or a year to review the product, depending on how it's classified.
Shara Rosen, analyst for Kalorama Information, said investing in Xenomics based on a product in the early testing stage is risky. But if the company is successful, the payoff could be huge, Rosen said.
"The Holy Grail right now in prenatal screening is either maternal blood or urine," said Rosen. "Everybody and his uncle is looking for something to replace amniocentesis. Next to cancer, it is the huge frontier."
White said that amniocentesis has a one percent chance of triggering a miscarriage. Another disadvantage is that amniocentesis is typically conducted when a woman is 16 weeks pregnant, said White, while he hopes his test could be done seven or eight weeks into the pregnancy.
The currently available blood tests look for elevated proteins that could indicate the presence of Down syndrome. White said these tests are only 75 percent accurate, and Rosen said they're not even comparable to amniocentesis.
Xenomics is not alone in trying to supplant the $175 million market for amniocentesis. There are about 10 companies researching blood tests for DNA, including German diagnostics company Qiagen (down $0.04 to $12.43, Research), said Rosen. But Xenomics' quest to detect Down syndrome DNA markers in urine could be unique, said Rosen.
With facilities in New York and New Jersey, Xenomics is in developmental stages and does not have products on the market. If the company is successful on the risky road to getting a prenatal DNA urinalysis on the market, it could be a revenue boon, said Rosen.
"If it works, whoa, it's like [the invention of the] printing press," said Rosen. "They've got a license to print money."
Rose does not own Xenomics stock and Kalorama does not conduct business with them.