NewswireToday - /newswire/ -
Bethlehem, PA, United States, 2013/10/15 - Florida Licensure Clears Path to Expand State Access of Clinical Laboratory Services for the MyCare™ Exposure Optimization Tests through Saladax Biomedical Laboratories - Saladax.com.
Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic tests that individually optimize a patient's exposure to chemotherapy, today announced that Saladax Biomedical Laboratories (SBL), its CLIA-certified laboratory division, has received state licensure from the Florida Department of Health to provide MyCare™ testing services to Florida clinicians and cancer patients. In addition to CLIA licensure, Florida is one of the five states requiring a clinical laboratory to have a specific-state license. Licenses have previously been granted to SBL from California, Rhode Island and Maryland.
“This is another significant milestone for SBL in that it expands and simplifies access to MyCare Exposure Optimization testing to oncologists and oncology care teams practicing in Florida. Expansion of the SBL laboratory operations is essential to our U.S. commercialization plan,” said Mark D. Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc.
MyCare blood tests provide oncologists with actionable information to determine the optimal chemotherapy dose to help maximize drug effectiveness and limit toxicity for their patients on an individual basis. SBL offers clinical laboratory testing services for Saladax MyCare™ Chemotherapy Exposure Optimization tests, including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. The MyCare testing services will continue to expand to include more than a dozen new exposure optimization tests that are currently in development.
About Saladax Biomedical, Inc.
Saladax Biomedical (saladax.com) is a leader in the development and deployment of high quality diagnostic services and products, delivering actionable data to help physicians to select and optimize the use of current and new pharmaceutical products, with the goals of improving health and positively impacting the economics of care. Saladax also serves as a valuable collaborator for pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.
Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified. Since 1988, laboratories must be inspected and pass stringent requirements to be certified and registered as a Clinical Laboratory Improvement Act (CLIA) laboratory. Saladax Biomedical Laboratories is certified and registered under the CLIA regulations by the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans.