Abbott gets FDA approval for ovarian cancer test

Posted June 3, 2010 at 10:47 a.m.

Associated Press | Abbott Laboratories said Thursday the Food and Drug Administration
cleared its new diagnostic test for the monitoring of ovarian cancer.

The FDA approved the company’s Architect HE4 blood test, which is used
to monitor the recurrence or progression of ovarian cancer.

The current test most widely used to monitor ovarian cancer, CA125,
measures levels of a protein in the blood as an indication that the
disease is possibly recurring or spreading. While 80 percent of ovarian
cancers express CA125, 20 percent of all ovarian cancers do not. Abbott
said using its new HE4 test in conjunction with methods such as CA125
gives physicians a more comprehensive clinical picture.


Ovarian cancer affects an estimated 1 out of every 71 women in the U.S. in their lifetimes, Abbott said. Ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of cancer death in women in the United States.

“Disease monitoring in ovarian cancer is crucial. Seventy-five percent of all ovarian cancer patients will have a recurrence,” said Cara Tenenbaum, vice president of policy and external affairs for the Ovarian Cancer National Alliance, in a statement. “New monitoring tools may provide patients and physicians with critical disease information to help make important treatment and care decisions.”

Abbott partnered with Fujirebio Diagnostics Inc. to develop the test. It also is approved for use in Europe, and other countries in the Asia Pacific and Latin American regions.

Shares of Abbott rose 11 cents to $47.59 in morning trading.

 

One comment:

  1. Lynn Millie June 17, 2010 at 11:58 a.m.

    Keep up the good work buddy!