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Three States OK Saladax to Offer MyCare Tests

NEW YORK (GenomeWeb News) – Saladax Biomedical on Thursday said that its Saladax Biomedical Laboratories division has received licenses from three states allowing it to provide its MyCare tests to clinicians in those states.

The licenses were granted by regulators in California, Rhode Island, and Maryland.

Saladax was certified as a registered CLIA lab at its Bethlehem, Pa., facilities in June, allowing it to start clinical laboratory operations for the MyCare portfolio of products throughout most of the US. In addition to CLIA certification, however, a handful of states require licensures by their regulators in order for a company to offer its testing products and services.

The MyCare product line comprises three chemotherapy exposure optimization assays, My5-FU, MyPaclitaxel, and MyDocetaxel. Saladax said it is currently developing more than a dozen additional assays to be part of the MyCare test menu services.

The company's CLIA laboratory is "at the heart of our US 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," Mark D. Myslinski, senior vice president and chief commercial officer at Saladax Biomedical, said in a statement.