Saladax Biomedical, a privately held company developing novel diagnostic tests that individually 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 and approval allows the company to begin clinical laboratory operations for the MyCare portfolio of products at its facilities in Bethlehem, Pa.
Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, will initially offer testing services for chemotherapy exposure optimization assays including My5-FU, MyPaclitaxel and MyDocetaxel in the U.S. SBL's testing services will expand to include more than a dozen new exposure optimization tests currently in development.
"This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests we believe give cancer patients the edge they need with their therapy," said Mark Myslinski, SVP and chief commercial officer at Saladax Biomedical.
Beginning in July, SBL will offer testing services for its initial chemotherapy exposure test portfolio, MyPaclitaxel, MyDocetaxel and the My5-FU test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers cost-effective blood tests for patient-specific chemotherapy dose optimization.
As a blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.