Prodesse Inc., a Waukesha-based biotechnology company, started clinical trials earlier this month for Pro hMPV+, a diagnostic test that the firm has developed for human metapneumovirus.
The virus causes respiratory illnesses, primarily in children.
hMPV is emerging as a virus of concern, according to Prodesse, and labs around the world are working on methods to detect its presence in patients. A Dutch company holds a series of patents pending for hMPV detection, and Prodesse is one of a few companies around the world that have been granted licenses to produce detection techniques.
The clinical trial, needed before the Food and Drug Administration allows Prodesse to bring Pro hMPV+ to market, will take two to three months, said Andy Shrago, senior vice president of sales and chief marketing officer.
The trials will be done at medical facilities in Hawaii, Texas, Ohio and Florida.
After the trials are done, Prodesse will need to do another approximate six months of testing in its lab in Waukesha before it could gain FDA approval, Shrago said.
Prodesse now has several similar products on sale in Europe, which has a faster regulatory environment, Shrago said.
“It’s not as exhaustive and extensive,” he said. “It’s easier to get to market.”
The company is now able to sell vials of the chemical that detects human medapnwumovirus now, Shrago said. The Pro hMPV+ product is a full testing kit with instructions, he said.
Prodesse has about 25 people working in Waukesha, and has doubled its revenues in each of the past several years, Shrago said.
“We are growing but we don’t expect our employment to grow tremendously,” he said. “We do intense research and development. And once you get that going, you can have intense growth in revenue.”