ARK Diagnostics - Methotrexate ll Assay
ARK Diagnostics, Inc. Announces Launch of FDA 510(k) Cleared ARK Methotrexate (MTX) II Assay for Enhanced Therapeutic Drug Monitoring
Fremont, California – [7/16/2024] – ARK Diagnostics Inc., a leader in innovative diagnostic solutions, proudly announces the release of the FDA 510(k) cleared ARK Methotrexate (MTX) II Assay, a cutting-edge homogeneous enzyme immunoassay designed for the precise quantitative determination of methotrexate levels in human serum or plasma. This new assay is optimized for use on automated clinical chemistry analyzers, providing healthcare professionals with a reliable tool for monitoring methotrexate.
Methotrexate, a critical medication for treating certain cancers and autoimmune diseases, requires careful monitoring to ensure therapeutic efficacy while minimizing toxicity. The ARK MTX II Assay offers a sophisticated solution for accurately measuring methotrexate levels, thereby supporting informed clinical decisions.
Key Features of the ARK MTX II Assay:
ARK Diagnostics - Is a leading innovator in the design, development, manufacturing, and distribution of in vitro diagnostic (IVD) and forensic immunoassays. These assays are crucial for therapeutic drug monitoring, pain management, drugs of abuse detection, and the measurement of other small molecules. Our proprietary assays provide accurate measurements of drug levels in biological fluids.
Contact Information:
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont, California, 94538
877-869-2320
sales@ark-tdm.com
www.ark-tdm.com
For more information about the ARK Methotrexate (MTX) II Assay, please visit our website or contact our customer service team
Fremont, California – [7/16/2024] – ARK Diagnostics Inc., a leader in innovative diagnostic solutions, proudly announces the release of the FDA 510(k) cleared ARK Methotrexate (MTX) II Assay, a cutting-edge homogeneous enzyme immunoassay designed for the precise quantitative determination of methotrexate levels in human serum or plasma. This new assay is optimized for use on automated clinical chemistry analyzers, providing healthcare professionals with a reliable tool for monitoring methotrexate.
Methotrexate, a critical medication for treating certain cancers and autoimmune diseases, requires careful monitoring to ensure therapeutic efficacy while minimizing toxicity. The ARK MTX II Assay offers a sophisticated solution for accurately measuring methotrexate levels, thereby supporting informed clinical decisions.
Key Features of the ARK MTX II Assay:
- Innovative Technology: Utilizes a new recombinant rabbit monoclonal antibody and recombinant enzyme conjugate, ensuring high specificity and reliability in methotrexate detection.
- Broad Measurement Range: Capable of precise methotrexate measurement in serum or plasma across a wide assay range of 0.030 to 1.300µmol/L.
- High Sensitivity: Boasts a limit of quantitation of 0.030µmol/L, allowing for the detection of low methotrexate concentrations.
- Minimal Interference: Exhibits less than 10% interference for all tested cross reactants, with cross-reactivity to 7-OH MTX at or below 0.01%.
- User-Friendly: Provided in liquid, ready-to-use bottles compatible with various clinical chemistry analyzers, simplifying laboratory workflows.
ARK Diagnostics - Is a leading innovator in the design, development, manufacturing, and distribution of in vitro diagnostic (IVD) and forensic immunoassays. These assays are crucial for therapeutic drug monitoring, pain management, drugs of abuse detection, and the measurement of other small molecules. Our proprietary assays provide accurate measurements of drug levels in biological fluids.
Contact Information:
ARK Diagnostics, Inc.
48089 Fremont Blvd.
Fremont, California, 94538
877-869-2320
sales@ark-tdm.com
www.ark-tdm.com
For more information about the ARK Methotrexate (MTX) II Assay, please visit our website or contact our customer service team
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