Saladax Biomedical, Inc., a company that develops products for testing the potency of chemotherapy drugs, has announced plans to create a laboratory that meets the Clinical Laboratory Improvement Amendments (CLIA) standards at the company's Bethlehem headquarters.
Saladax has submitted applications for a CLIA license with both the state and the federal governments and plans to launch the laboratory in 2013.
"Expanding our business model to include both the supply of diagnostic reagent kits and the provision of clinical laboratory services gives Saladax the flexibility to successfully address unique market conditions," said Kevin Harter, CEO and president of Saladax.
"Our goal is to improve the safety, quality of life and life expectancy of cancer patients around the world and to do so meeting the ever-growing demand for better care at lower costs."
Saladax Biomedical Inc. is a privately held company developing and commercializing novel diagnostic assays – or potency tests – to achieve the promise of personalized medicine for new and existing therapeutics.
In conjunction with expanding its presence at Ben Franklin TechVentures in Bethlehem, Saladax will hire additional professionals as it grows its commercial capabilities. Recently, the company appointed Mark Myslinski as its new chief commercial officer. He will be responsible for the CLIA laboratory and the worldwide commercialization of the MyCare assays.
"Establishing a commercial infrastructure that includes a CLIA-certified laboratory will allow Saladax to penetrate the US market more efficiently and is key to our long-term business strategy," said Myslinski. "We are excited to bring the full line of our novel diagnostic solutions to cancer patients throughout the world and continue serving our partners as the dose management provider of choice."
The commercialization strategy of Saladax is built upon its proprietary MyCare therapeutic dose management assays designed to reduce the toxicity associated with chemotherapy drugs while optimizing treatment efficacy for cancer patients.
An additional ten MyCare assays are in development and will be commercialized through the company's CLIA laboratory in the U.S.