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Dec. 6, 2012 /PRNewswire/ -- Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today its plans to create a laboratory that meets the Clinical Laboratory Improvement Amendments (CLIA) standards at the company's headquarters in
Bethlehem, PA. Saladax has submitted applications for a CLIA license with both the state of
Pennsylvania and the federal government and plans to launch the laboratory in 2013.
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. The first MyCare assays measure the widely prescribed 5-fluorouracil, paclitaxel and docetaxel and are offered in kit form in markets outside the US. An additional ten MyCare assays are in development and will be commercialized through the company's CLIA laboratory in the US.
"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 & 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."
In conjunction with expanding its presence at Ben Franklin TechVentures in
Bethlehem, PA, Saladax announced plans to hire additional professionals as it grows its commercial capabilities. Recently, the company announced the appointment of
Mark Myslinski as its new Chief Commercial Officer who 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
Mark 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."
In the US, the Centers for Medicare & Medicaid Services (CMS) regulate laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. A CLIA laboratory is one that operates under CLIA supervision. In total, there are approximately 200,000 CLIA certified laboratory entities in the US.