11 Nov Third Wave to seek FDA clearences after expanding pipeline
Madison, Wis. — Third Wave Technologies has expanded its product pipeline and will seek FDA clearance for several products within the next few years, the company told investors and analysts on Thursday. Third Wave, based in Madison, makes molecular genetic diagnostics.
The company said revenue in 2005 would probably be driven primarily by its genetics, cystic fibrosis and hepatitis C genotyping reagents. It plans to seek FDA clearance for certain coagulation tests next year.
Milwaukee-headquartered analyst firm R.W. Baird kept its neutral rating of the company’s stock, saying in a report that Third Wave is making progress but is dependent on the adoption of its new products.
- Third Wave recently reported becoming profitable and turning over some key management positions. Read more here.
Third Wave expects to seek FDA clearance for in-vitro diagnostics for Factor V Leiden, a hereditary blood disease, and Factor II prothrombin deficiency, a form of hemophilia. The company said the products are already on the market, but FDA clearance would allow more direct marketing efforts.
The company plans to add to its diagnostics for infectious diseases. Products planned for expansion during 2005 include tests for the hepatitis C virus; three different herpes viruses; the Varicella-Zoster virus, a cause of shingles; Cytomegaloirus, which can kill organ-transplant patients; and Epstein-Barr virus.
Finally, Third Wave plans to expand into the oncology market with diagnostics for subtelomere problems and microdeletions, both small changes to chromosomes that can cause developmental problems or illness.