Saladax Biomedical, Inc. Announces the Formation of a CLIA Laboratory As Part of the Company’s Commercialization Strategy
BETHLEHEM, Pa., 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(TM) 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.
About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. Our proprietary line of MyCare(TM) assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. Saladax’s initial focus is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. Three MyCare assays, My5-FU(TM), MyPaclitaxel(TM) and MyDocetaxel(TM), are currently offered to the oncology community in markets around the world.
The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.
The company was founded in 2004 and is headquartered in Bethlehem, Pennsylvania. Saladax is ISO 13485:2003 certified.
Saladax Biomedical, Inc.
Adrienne Choma, Esq.
Sr. VP & Chief Operating Officer
SOURCE Saladax Biomedical, Inc.