Saladax Biomedical, US-based developer of diagnostic tests that optimize a patient's exposure to chemotherapy, has been certified as a registered CLIA Laboratory from 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.
The CLIA certification is considered to be a milestone for Saladax, allowing it to commence clinical laboratory operations for the MyCare portfolio of products at its facilities located in Bethlehem, Pennsylvania.
Initially, Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, will offer testing services for chemotherapy exposure optimization assays including My5-FU, MyPaclitaxel and MyDocetaxel in the U.S.
SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.
Saladax Biomedical SVP and chief commercial officer Mark Myslinski said this is a significant milestone for SBL as the company’s CLIA laboratory operations are at the heart of the US commercialization plan that will include an expanding suite of MyCare exposure optimization tests that give cancer patients the edge they need with their therapy.
"The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.," Myslinski added.
Effective from 1 July, 2013, SBL will provide testing services for the initial chemotherapy exposure test portfolio, MyPaclitaxel, MyDocetaxel and the My5-FU test that is being transitioned from Myriad Laboratories.
The MyCare technology platform offers rapid and cost-effective blood tests for patient-specific chemotherapy dose optimization.
MyCare products, as a simple blood test, will provide vital information to analyze the optimal chemotherapy dose that is needed to increase the effectiveness and limit toxicity for the patients.