Profile: Diadexus, Inc. provides novel diagnostic products. Our PLAC test is an FDA-approved blood test for identifying stroke risk. The test measures levels of Lp-PLA2, or lipoprotein-associated phospholipase A2, an enzyme with a unique mechanism of action causal in the formation of vulnerable, rupture-prone plaque. Plaque rupture is the major cause of both heart attack and stroke. The PLAC test is a cardiovascular risk stratification tool to identify those patients who should be targeted with the most aggressive treatment strategies to reduce the risk of stroke or heart attack.
6 Products/Services (Click for related suppliers)
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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: |
| • Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. |
| • Lipoprotein-Associated Phospholipase A2 Immunoassay Test System (FDA Code: NOE / 866.5600) A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases. |
| • Low Density Lipoprotein (FDA Code: DFC / 866.5600) |
| • Molecular Analyte Specific Reagents (ASR) |
| • Secondary Calibrator (FDA Code: JIT / 862.1150) A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.) |