Secures CE Mark Registration for Therapeutic Dose Management (TDM) Assays MyPaclitaxel™ and MyDocetaxel™
BETHLEHEM, Pa., July 9, 2012 /PRNewswire/ -- Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today the company has achieved CE mark registration for its MyPaclitaxel™ and MyDocetaxel™ therapeutic dose management (TDM) MyCare™ assays, enabling commercialization in the European Union (EU).
Saladax's MyCare technology platform offers automated, rapid, robust and cost-effective in vitro diagnostic tests for patient-specific chemotherapy dose optimization. These new tests enable a physician to determine the optimal treatment effectiveness/toxicity balance for each unique patient.
"We are gratified to expand our offering of MyCare tests to cancer patients in the EU," said Kevin M. Harter, president and CEO of Saladax. "There is a significant need to provide patients personalized drug dosing to achieve optimal therapeutic benefits while at the same time maintaining a high quality of life. Our MyCare tests, which measure the concentration of paclitaxel or docetaxel in patients' blood, give oncologists the objective information they need to adjust their patients' dose to their individual needs. Adding MyPaclitaxel and MyDocetaxel to the already available My5-FU assay will allow us to help an even broader segment of patients."
Approximately 225,000 cancer patients in the EU are treated with the taxane drugs annually. Paclitaxel is predominantly used to treat ovarian, breast, non-small cell lung (NSCLC) and uterine cancers. Similarly, docetaxel is used to treat breast cancer and NSCLC, but is also an important component of prostate and head and neck cancer treatment regimens. Both of these drugs cause serious toxic side effects, with upwards of 80% to 90% of patients suffering from low white blood cell counts that leave patients susceptible to serious and even life-threatening infections.
Both paclitaxel and docetaxel are typically dosed based on a body surface area (BSA) calculation, which does not account for how individuals absorb and clear medications from their bloodstream. Research has demonstrated that patients' reactions to receiving similar BSA-based doses of paclitaxel and docetaxel can vary dramatically. For example, patients receiving the same initial amount of these chemotherapy drugs have been found to metabolize them at very different rates resulting in different levels in the bloodstream. When a patient metabolizes the drug too quickly, there is not enough drug in the bloodstream to kill the cancer cells. Conversely, when a patient metabolizes the drug too slowly, the drug blood level can be very high and cause toxicity. This can compromise treatment benefits to patients and cause premature termination of treatment. Saladax developed the MyPaclitaxel and MyDocetaxel assays to enable oncologists to measure their patients' blood drug levels and adjust the dose for those who are at high risk of serious side effects.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 some markets.
The company's MyCre technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology capability 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.
Saladax Biomedical, Inc.
Adrienne Choma, Esq.
Sr. VP & Chief Marketing Officer
SOURCE Saladax Biomedical, Inc.