Saladax Receives Out-Of-State Laboratory Licenses And Approvals To Expand MyCare™ Clinical Laboratory Testing To Clinicians In CA, RI And MD
Milestone Clears Path to Expand State Access of Clinical Laboratory Services for the MyCare™ Exposure Optimization Tests through Saladax Biomedical Laboratories
Bethlehem, PA /PRNewswire-iReach/ - 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) has received its licenses from the state-specific Departments of Health for California,Rhode Island and Maryland.
"This is another significant milestone for SBL in that it opens up access to the suite of MyCare tests in states requiring specific state licensure, and it simplifies access to the testing in states accepting medical necessity documents. The SBL CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients and their medical team another tool to assist with personalizing their therapy," said Mark D. Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc.
Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., currently offer clinical laboratory testing services for Saladax MyCare chemotherapy exposure optimization assays, including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. The MyCare test menu will expand to include more than a dozen new exposure optimization tests that are currently in development. As a simple blood test, MyCare tests provide oncologists with actionable information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.
About Saladax Biomedical, Inc.
Saladax Biomedical is a leader in the development and deployment of high quality diagnostic services and products, delivering actionable data to help physicians 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 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.
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SOURCE: Saladax Biomedical Inc.Copyright 2013 PR Newswire. All Rights Reserved