New, Non-invasive Urine DNA Test Developed for Pregnant Women for Early Detection of Pre-natal Abnormalities

(I-Newswire) December 23, 2004 - A new urine DNA test may provide pregnant women a safer, quicker and non-invasive procedure to detect Downs Syndrome and other abnormalities in the fetus.

Chromosomal abnormalities can now be diagnosed by pre-natal testing. But the risks of invasive tests such as aminocentesis may be greater than the benefits.

A new "transrenal DNA" test developed by Xenomics, Inc., a biotechnology company headquartered in New York City, would eliminate the trauma and pain of invasive surgery because it analyses DNA in urine rather than blood.

"With a simple urine collection, we can give you an earlier diagnosis, and you get away from all the risks that are attendant to aminocentesis," said Xenomics CEO V. Randy White.

"You're not sticking a nine-inch needle into somebody's abdomen and withdrawing fluid. You're not running the risk of infection or spontaneous abortion."

White said scientists are working to design a test specifically for detection of Downs Syndrome to submit for approval.

Medical testing laboratories would perform the pregnancy tests, which White estimated would cost about $400, compared with the current $1,200 tab for aminocentesis.

Eventually, he said, a suite of tests is planned for the early detection or monitoring of other conditions, including cancer tumors and organ transplant rejection.

White explained how the new technology works.

"Every day in your body, about a hundred billion cells die, and the DNA that's in them gets chopped into pieces and carried away by the bloodstream," he said. "A portion of these pieces passes through the kidneys and ends up in a person's urine."

Xeonomics scientists were the first in the world to develop the technology to find the origin of these fragments.

"These pieces are unique, and we can tell where they came from -- from a fetus, from a tumor, from a transplanted organ, from an infectious agent within the body," said White.

In pre-natal testing, for example, the developing fetus has very different DNA than the mother.

In attempting to detect Downs Syndrome or other genetic problems, it normally requires invasive techniques such as aminocentesis after 15 weeks of pregnancy. But White said with urine DNA analysis the fetal DNA can be found as early as six weeks.

On organ implants, White said:

"If you are given my heart, you have my DNA inside your body, and my DNA is going to appear in your urine. So if there is more donor DNA coming out, it is the signal for organ rejection. The only way now to determine this is through a needle biopsy."

In cancer detection, White said, the role of urine DNA is a little different.

"We can genetype tissue that has been removed and then monitor your urine for re-growth of that tumor," he said.

The new test also may be the medicine Big Pharma doctors are looking for to trim skyrocketing costs of conducting clinical trials.

More than 60% of the cost of developing new drugs is spent on conducting clinical trials, according to industry experts, and the tab is rising at a rate greater than the number of new drugs generated through such an enormous investment.

As a result, pharmaceutical companies are eagerly seeking to improve the efficiency and effectiveness of the clinical trial process.

"The biggest problem facing pharmaceutical companies performing clinical trials is that they have to cast a large net to find patients who will respond to their drug," said White. "It could involve 1,000 patients and they will need needle biopsies if, for instance, they are enrolling patients with liver cancer."

But with the urine DNA test, he said, only about 300 patients would be required, and as a result, the identification of patients who are going to respond to a drug will be quicker and less expensive.

In about six months, White said, Xenomics will reach out to major pharmaceutical companies to discuss the urine DNA technology for use in clinical trials.

"We will tell them of our ability to more efficiently carry out clinical trials by reducing risk, elimination of costly invasive procedures, saving time while simultaneously enhancing the strength of the clinical database, through the ability to perform unlimited repeated tests," he said.

White, who joined Xenomics last September, has more than 30 years of experience in top management positions in the medical diagnostic industry.

At American Medical Laboratories, he helped shape the company from a regional laboratory with revenues of $72 million to a national reference lab with more than $310 million in revenue. The company was sold in 2002 to Quest Diagnostics, Inc., for $500 million.

White directed the scientific operations at National Health Laboratories Holdings, Inc., as the business grew from $20 million in revenues to $850 million in revenues. In 1995, the company merged with Roche Biomedical Laboratories, Inc., to form LabCorp.

He also worked at Nanogen, Inc., and oversaw the company revenue grow from zero to $8 million.

(Xenomics, Inc., maintains its headquarters at 420 Lexington Avenue, New York City. T. 212-729-9216.)

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