Digene optimism rises over cancer test

FDA panel gives boost to its use with Pap smear

March 12, 2002|By Andrea K. Walker | Andrea K. Walker,SUN STAFF

Digene Corp., a maker of medical diagnostic tests, expects the marketing potential of its DNA-based cervical cancer test to increase 10-fold if the U.S. Food and Drug Administration approves expanded use.

The Gaithersburg-based company cleared a major hurdle Friday when an FDA advisory panel recommended that Digene's test, with conditions, be used in conjunction with the Pap smear as a primary detector of cervical cancer. The FDA generally follows the advice of its advisory panels, which are made up of outside experts.

Currently, the Pap smear is the standard test used in detecting the disease. Digene's test now is FDA-approved for use only when a Pap yields inconclusive results.

Prior to approval, the advisory panel said, Digene must provide more clinical evidence showing the effectiveness of its test. The panel also told the company to create an educational program to be used by physicians and other health care professionals that explains the benefits and correct use of the test.

It is unclear when the FDA will make a decision, but Digene officials are hoping approval will come this year.

"It's going to be a large expansion in our marketing opportunity," said Charles M. Fleischman, Digene's president.

The test is now used by about 3 million to 4 million women, Fleischman said. With FDA approval, the company could target the 30 million to 40 million women who get Pap tests every year.

"It brings their product into a new market and opens up a new niche for them," said Tom Burnett, an analyst with Merger Insight, an affiliate of the New York brokerage firm Wall Street Access.

Digene's test detects the presence of human papillomavirus, a sexually transmitted disease present in almost all cases of cervical cancer.

"It allows physicians to detect not only who has the disease today, but which women harbor the cause of cervical cancer," Fleischman said. "We can prevent the cancer before it breaks out."

Cytic Corp. announced last month that it was acquiring Digene for $537.6 million in cash and stock.

The Massachusetts-based company said the deal positioned it to combine its ThinPrep Pap test with Digene's DNA test.

Shares of Digene rose $1.05 yesterday to $34.65.

Some analysts said FDA approval of the Digene test could cause officials with the Federal Trade Commission - which must approve the merger - to take a closer look at the deal.

"We think it makes sense, and we expect the merger to go through," said Burnett. "It's all good news except for this small fly in the ointment that could cause more FTC scrutiny."

Baltimore Sun Articles
Please note the green-lined linked article text has been applied commercially without any involvement from our newsroom editors, reporters or any other editorial staff.