Saladax Biomedical, Inc.
Saladax Biomedical develops and manufactures therapeutic drug monitoring (TDM) assays for essential and life-saving medications prescribed by psychiatrists and oncologists. Their assays ensure patients receive their optimal dose, improving outcomes, reducing toxicity, and shortening hospital stays. They collaborate with pharmaceutical companies to develop tests for clinical trials and diagnostics, and their proprietary technology has been used worldwide since 2007. The company has received multiple approvals, collaborations, and awards, and is actively involved in advancing personalized medicine through innovative diagnostic tests and point-of-care solutions.
Industries
Nr. of Employees
small (1-50)
Saladax Biomedical, Inc.
116 Research Drive, Bethlehem, PA 18015, USA
Patents
Immunoassay standards and measurement of clinical biomarkers using intra-assay calibration standards
US-9482665-B2
View Details
Immunoassay standards and measurement of clinical biomarkers using intra-assay calibration standards
US-9482665-B2
View DetailsProducts
Point-of-care single-drop antipsychotic drug testing device and assays
Point-of-care device and associated immunoassays that measure blood concentrations of antipsychotic drugs from a single finger-prick sample and provide rapid results to support dosing and adherence decisions.
Laboratory immunoassay reagent kits for therapeutic drug monitoring
Reagent kits and automated immunoassays designed to run on clinical chemistry analyzers to quantify drug levels for chemotherapy agents and antipsychotic medications, intended for high-throughput laboratory use.
CSF biomarker immunoassays for Alzheimer's disease
Immunoassays for detection of cerebrospinal fluid biomarkers (amyloid beta and tau) intended for early-stage Alzheimer's disease research and diagnostic workflows, with technology transfer support for commercialization partners.
Point-of-care single-drop antipsychotic drug testing device and assays
Point-of-care device and associated immunoassays that measure blood concentrations of antipsychotic drugs from a single finger-prick sample and provide rapid results to support dosing and adherence decisions.
Laboratory immunoassay reagent kits for therapeutic drug monitoring
Reagent kits and automated immunoassays designed to run on clinical chemistry analyzers to quantify drug levels for chemotherapy agents and antipsychotic medications, intended for high-throughput laboratory use.
CSF biomarker immunoassays for Alzheimer's disease
Immunoassays for detection of cerebrospinal fluid biomarkers (amyloid beta and tau) intended for early-stage Alzheimer's disease research and diagnostic workflows, with technology transfer support for commercialization partners.
Services
Collaborative development of immunoassays for clinical trial endpoints and companion diagnostic programs, with support from concept through analytical and clinical validation.
Process transfer from R&D to manufacturing, process validation and scaling manufacturing volumes for reagent kits and automated immunoassays; contract manufacturing for external partners.
Provision of validated reagent components, assay protocols and licensing of intellectual property to commercialization partners and instrument manufacturers.
Deployment support for point-of-care testing programs including device connectivity to health systems, real-time data transfer, AI-based result processing and visualization to support rapid clinical decisions.
Establishing and managing distribution agreements and regional partnerships to commercialize laboratory and point-of-care diagnostic assays.
Collaborative development of immunoassays for clinical trial endpoints and companion diagnostic programs, with support from concept through analytical and clinical validation.
Process transfer from R&D to manufacturing, process validation and scaling manufacturing volumes for reagent kits and automated immunoassays; contract manufacturing for external partners.
Provision of validated reagent components, assay protocols and licensing of intellectual property to commercialization partners and instrument manufacturers.
Deployment support for point-of-care testing programs including device connectivity to health systems, real-time data transfer, AI-based result processing and visualization to support rapid clinical decisions.
Establishing and managing distribution agreements and regional partnerships to commercialize laboratory and point-of-care diagnostic assays.
Expertise Areas
- Therapeutic drug monitoring (TDM)
- Point-of-care diagnostics and clinical deployment
- Assay development and validation for oncology and psychiatry
- Clinical laboratory analyzer integration and automated immunoassays
Key Technologies
- Point-of-care single-drop whole-blood testing
- Automated immunoassay formats for clinical chemistry analyzers
- Nanoparticle-enhanced assay reagents
- CSF biomarker immunoassays for amyloid beta and tau
News & Updates
Bethlehem, PA – May 14, 2024 – Saladax Biomedical, Inc. (Saladax) is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale in Canada.
Fully automated immunoassay kit designed to simplify and streamline busulfan therapeutic drug monitoring (TDM).
Bethlehem, PA – September 19, 2018 – Saladax Biomedical Inc. announced new guidelines for 5-Fluorouracil therapy.
Recorded in July 2023 at Saladax’s first Virtual Product Theater, this session discusses factors to consider when looking for a response to clozapine titration and how rapid blood levels can facilitate treatment.
A new finger prick test reduces the need for traditional blood testing, cutting the wait time from 5-10 days to around six minutes, supporting rapid clinical decision-making.
South London and Maudsley NHS Trust have implemented a new blood test that reduces waiting time for results from around 10 days to just six minutes, enabling faster treatment adjustments.
Bethlehem, PA – May 14, 2024 – Saladax Biomedical, Inc. (Saladax) is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale in Canada.
Fully automated immunoassay kit designed to simplify and streamline busulfan therapeutic drug monitoring (TDM).
Bethlehem, PA – September 19, 2018 – Saladax Biomedical Inc. announced new guidelines for 5-Fluorouracil therapy.
Recorded in July 2023 at Saladax’s first Virtual Product Theater, this session discusses factors to consider when looking for a response to clozapine titration and how rapid blood levels can facilitate treatment.
A new finger prick test reduces the need for traditional blood testing, cutting the wait time from 5-10 days to around six minutes, supporting rapid clinical decision-making.
South London and Maudsley NHS Trust have implemented a new blood test that reduces waiting time for results from around 10 days to just six minutes, enabling faster treatment adjustments.