TriPath Imaging (Nasdaq: TPTH) has been informed that Digene (Nasdaq: DIGE) anticipates receiving a “not approvable” letter from the U.S. Food and Drug Administration for its Pre-Market Approval (PMA) supplement application to use TriPath’s SurePath Test Pack as a specimen collection medium for Digene’s Hybrid Capture 2 DNA Test.
TriPath expects to receive a copy of the FDA letter once it has been received by Digene. It is Tripath’s understanding, the company says, that the FDA is requesting additional information, including additional clinical data.
“We expect to work closely with the FDA and Digene to understand and to promptly resolve the FDA’s issues,” TriPath Chairman, Chief Executive and President Paul R. Sohmer said in a statement. “We remain hopeful that resolution of the FDA’s issues will not significantly alter our prior expectations for introduction in 2003.”
Sohmer said that TriPath expects to report solid results for its second quarter, which closed on June 30. The company will discuss its financial results during a conference call with the investment community on July 17. By that time, Sohmer says TriPath also hopes to have additional information related to the Digene PMA Supplement.
TriPath develops, manufactures, markets and services innovative solutions to improve the clinical management of cancer, including detection, diagnosis, staging and treatment. Digene, based in Gaithersburg, Md., manufactures and markets gene-based testing systems for the screening, monitoring and diagnosis of human diseases. Its primary focus is in women’s cancers and infectious diseases.
TriPath Imaging: www.tripathimaging.com
Digene:
www.digene.com
