By Jim Stafford
Business Writer
As printed in The Oklahoman, November 14, 2007.

After an unexpected detour of almost two years, the OncoVue genetic breast cancer risk test developed by Oklahoma City-based InterGenetics, has been released nationwide.

"It's tremendously exciting news," said Dr. Craig Shimasaki, president and chief executive officer of InterGentics. "This is what we've been working for now for about 14 years of research."

The company had passed all federal and state CLIA (Clinical Laboratory Improvement Amendments) certifications and was ready to launch the $397 OncoVue test in February 2006 when the Food and Drug Administration determined that full FDA approval was needed before it could be commercially released.

So, the test was launched as a limited "FDA Investigational Device Exemption study" in 19 cities. The FDA now has said it will honor CLIA certification, which paved the way for the commercial launch of the test.

"We have centers in 13 states that are eager to begin commercial testing," Shimasaki said.

"We have about 20 more that are on a waiting list and interested in being trained to offer the test to its patients."

About the test
The OncoVue test allows a woman to swish a mouthwash substance in her mouth and deposits the fluid in a tube. The genetic material is sent to the InterGentics laboratory where DNA from the woman's cheek cells is analyzed, along with data from a medical questionnaire.

The test was developed from research examining genetic variants influencing breast cancer risk in women between the ages of 30 and 69.

Research began with the Noble Foundation and later transferred to the Oklahoma Medical Research Foundation before it was spun off into the company that became InterGenetics, Shimasaki said. InterGenetics collected genetic information from 8,000 women in six geographic areas of the country to document the accuracy of the test.

The test is now commercially available through the InterGenetics Breast Cancer Risk Testing Network in Oklahoma, Illinois, Maryland, Indiana, Arizona, Kansas, Pennsylvania, Nevada, Michigan, Washington, Tennessee, Idaho and Texas.

Melissa Craft, a registered nurse and oncology clinical nurse specialist at the Breast Imaging Center of Oklahoma, has administered the test to more than 200 women over the past year. Results are promising, she said.

"I would say the test is very helpful," Craft said. "It gives us an idea where a person is related to other people."

About the company
InterGenetics employs 19 people in the Presbyterian Health Foundation Research Park. The company has raised $12.5 million in investment capital, Shimasaki said.

This article appeared in The Oklahoman, www.newsok.com, on November 14, 2007.