Saladax Biomedical, Inc. Extends Availability of its MyCare™ Portfolio in Europe
Secures CE Mark Registration for Therapeutic Dose Management (TDM) Assays MyPaclitaxel™ and MyDocetaxel™
Bethlehem, PA, July 9, 2012 – 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 personalization to achieve optimal efficacy/toxicity balance.
“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 titer 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 neutropenia, which is caused by 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 receiving BSA-based paclitaxel and docetaxel can show greater than ten-fold and seven-fold variability in blood drug level concentrations respectively. This can cause excessive toxicity and compromise treatment benefits to patients. 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 MyCare 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 13485:2003certified.Saladax Biomedical, Inc. Adrienne Choma, Esq. Senior VP & Chief Marketing Officer moc.x1493618942adala1493618942s@amo1493618942hca1493618942 Media Contact: Tiberend Strategic Advisors, Inc. 212-827-0020 Andrew Mielach moc.d1493618942nereb1493618942it@hc1493618942aleim1493618942a1493618942 or: Claire Sojda moc.d1493618942nereb1493618942it@ad1493618942josc1493618942