Profile: Saladax Biomedical, Inc. is a personalized medicine diagnostics company that has developed immunoassay technology for dose management of chemotherapy agents. Our assays are evidence-based tools that help guide the clinician in providing effective and safe drug therapy to individual patients. Most cancer drugs have a narrow therapeutic index and a dose limiting toxicity profile that make these drugs ideal candidates for dose management through the measurement of drug concentrations in blood. These simple blood tests enable an oncologist to optimize dosing for target drug levels to achieve optimal balance of efficacy and toxicity, where the loss of this balance can have devastating effects on patients. We develop assays for the most common anticancer drugs. We specialize in the development of assays that enable personalized treatment for cancer patients. Our assays measure chemotherapy drugs in a patient's blood using proprietary monoclonal antibodies bound to nanoparticles.
FDA Registration Number: 3005567065
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• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to: |
• Breast Cancer Detection Kit Test |
• Breast Cancer Test |
• Chemotherapy Containers |
• Colorectal Cancer Test |
• Diagnostic Rapid Test Kits |
• Diagnostic Test Kits |
• Infusion Therapy Kits |
• Ovarian Cancer Test |