Saladax Biomedical Laboratories to Offer the Full Portfolio of MyCare™ Therapeutic Dose Management Assays in the United States
Saladax Regains Rights to the My5-FU™ Assay Licensed to and Marketed by Myriad Genetics as OnDose®
Bethlehem, PA, February 11, 2013 – Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine, announced today that the My5-FU™ Assay will be part of the Saladax Biomedical Laboratories MyCare™ service offering when the CLIA laboratory located in Bethlehem, PA commences operations later this year.
My5-FU is a simple blood test that provides oncologists with objective information to guide optimized dosing of 5-fluorouracil (5-FU), controlling toxic side effects and improving treatment efficacy for cancer patients. The test has been offered in the United States by Myriad Genetics, Inc. (Nasdaq: MYGN) under the trade name OnDose®, but rights to this assay will revert to Saladax when the Saladax Biomedical CLIA lab becomes operational in June 2013.
“We’re extremely pleased to bring our entire line of MyCare™ oncology therapeutic dose management assays under one roof,” said Kevin Harter, CEO & President of Saladax. “With the creation of the Saladax Biomedical Laboratories, cancer patients in the US can be better served with a single source for all oncology dose management testing services.
“The CLIA laboratory expands the business model beyond the supply of diagnostic reagent kits in other markets of the world to include a clinical testing service for the US market. Saladax can provide assistance to cancer patients through channels best suited in specific markets,” added Mark D. Myslinski, Senior VP and Chief Commercial Officer.
Saladax Biomedical Laboratories will initially be offering testing services for MyPaclitaxel™ and MyDocetaxel™, as well as My5-FU™, and the menu will be further expanded with an additional 10 oncology dose management assays as their development is completed. The MyCare technology platform offers automated, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization. These tests enable a physician to determine the optimal treatment effectiveness/toxicity balance for each unique patient.
OnDose will continue to be promoted and sold by Myriad through June, when the Saladax Biomedical Laboratories becomes operational and the customer base is transitioned to Saladax.
About Saladax Biomedical, Inc. Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. Our proprietary line of MyCare™ 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™, MyPaclitaxel™ and MyDocetaxel™, are currently offered to the oncology community in markets around the world and will be available from Saladax Biomedical Laboratories mid-year 2013.
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. CLIA # 39D2052285.