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Central Laboratories

New Biomarker Assay Validations from Medpace’s Central Labs

  • September 12, 2018
Biomarker Assay Validations

Medpace’s central laboratories continuously works to expand our available assay lists. With an already robust menu of validated assays, the increase in new biomarker assay validations speaks to the seamless service we provide to our Sponsors. Our scientific team’s 20 plus years in biomarker development allows us to validate assays quickly and effectively. Notably, we validate new biomarkers in an industry-leading 10 to 12 weeks. Led by Ph.D. level scientists, our successful biomarker strategy utilizes a flexible approach with state of the art techniques to provide results that enable patient stratification and improves the prediction of drug efficacy and safety.

New Biomarker Assay Validations

Test: Axl, Soluble (sAXL)
Clinical Significance: Human Axl is a receptor tyrosine kinase that is expressed in mammalian vascular and immune
cells. Axl signaling is involved in the regulation of the inflammatory response. Elevated levels of s-Axl have been
observed in several diseases including aortic aneurysm, systemic lupus erythematosus, rheumatoid arthritis, and preeclampsia. Current studies are investigating s-Axl as a biomarker in patients with chronic liver disease. These patients are at a higher risk for hepatocellular carcinoma.

Test: Amino-Terminal Pro-Atrial Natruiretic peptide (NT-ProANP)
Clinical Significance: Atrial Natriuretic peptide (ANP), also known as gamma-ANP, cardiodilatin-related peptide (CDP), and natriuretic peptide A (CDD-ANF), is a secreted member of the natriuretic peptide family of molecules. ANP is expressed in multiple cell types including atrial myocardiocytes, macro phages, and select hypothalmic neurons. Elevated circulating levels of ANP are associated with heart failure resulting from increased mechanical stress in the heart during hypertension.

Test: Angiopoietin-like 4 (ANGPTL-4)
Clinical Significance: Angptl4 is a protein that is encoded by the Angptl4 gene. This gene is induced under hypoxic conditions in various cell types and is the target of peroxisome proliferator-activated receptors. The Angptl4 protein is a serum hormone directly involved in regulating lipid metabolism. It is a potent inhibitor of serum triglyceride clearance, causing elevation of serum triglyceride levels via inhibition of the enzyme lipoprotein lipase (LPL).

Test: Angiotensinogen (AGT)
Clinical Significance: AGT is the precursor of angiotensin and is cleaved into angiotensin I and II in the reninangiotensin system, and it has long been reported to play an important role in controlling blood pressure.

Test: C-MET
Clinical Significance: c-Met exists mainly in epidermal cells. It is found in the digestive tract, prostate gland, seminole vesicles, mammary gland, microglia cells, monocytes, and macrophages, with more amounts in the liver and kidney. It is thought that c-Met transmit signals resulting from binding to hepatocyte growth factor (HGF), such as growth, motility and organ formation, in the organs and cells aforementioned.

Clinical Significance: In patients who are immunocompromised, CMV may cause disseminated, severe disease. CMV is also the most common cause of congenital viral infection in humans. Quantitative PCR methods may be useful in monitoring CMV replication in immunosuppressed patients or in determining the viral load of CMV in amniotic fluid.

Test: Direct Coombs (DAT)
Clinical Significance: The direct antiglobulin test (DAT) looks for antibodies attached to red blood cells (RBCs) circulating in the bloodstream. The test may help to detect or identify conditions in which antibodies become attached to RBCs, causing them to hemolyze.

Test: Endothelin 1 urine
Clinical Significance: Endothelin-1, a peptide of 21 amino acid residues, is a pleiotropic molecule best known for its action as a potent vasoconstrictor. Endothelin-1 also stimulates cardiac contraction and the growth of cardiac myocytes, regulates the release of vasoactive substances, and stimulates smooth muscle cell mitogenesis.

Test: FGF-23 C-terminus and FGF-23 intact
Clinical Significance: The measurement of human FGF-23 levels in the blood is likely to provide an important diagnostic tool for the laboratory evaluation of patients with a variety of different hypophosphatemic and hyperphosphatemic disorders. Furthermore, the sensitive measurement of FGF-23 is likely to provide novel insights into the regulation of bone and mineral homeostasis.

Test: Growth Hormone
Clinical Significance: hGH or somatotropin is the hormone most abundantly secreted by the pituitary. During childhood and adolescence it causes body statural growth, and throughout life, it affects major metabolic processes, in such a way that growth is encouraged. hGH is secreted episodically (pulsatile secretion) and, in normal subjects, it is modulated by many factors including stress, physical exercise, and sleep. The test is of help in diagnosing growth disorders: Hormone deficiency, including delayed puberty and small stature in adolescents.

Test: Interleukin-1 Receptor Antagonist (IL-1ra)
Clinical Significance: Interleukin-1 receptor antagonist (IL-1Ra) is a 22-25 kDa member of the IL-1 family of cytokines. It is an acute phase protein that exists to dampen inflammation. IL-1Ra blocks IL-1 action through competitive inhibition. A number of cell types express IL-1Ra, including monocytes, Sertoli cells, hepatocytes, adipocytes, synovial fibroblasts, mast cells, pancreatic alpha-cells, and intestinal epithelial cells.

Test: Interleukin-2 Receptor alpha (IL-Ra)
Clinical Significance: A soluble form of IL-2 Rα appears in serum, accompanied by its increased expression on cells. Increased levels of the soluble IL-2 Rα in biological fluids reportedly correlate with increased T and B cell activation and immune system activation. A correlation is suggested of levels of IL-2 Rα in serum with the onset of rejection episodes in allograft recipients, with activity of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosis and with the course of some leukemias and lymphomas.

Test: LIH
Clinical Significance: A number of diseases and pre-analytical conditions can result in increased concentrations of chromogens like bilirubin, hemoglobin and lipids/turbidity in body fluids. Chromogens can interfere with photometric tests. The users of these test systems should evaluate the sample quality and identify potentially interfering substances in these samples. This evaluation is often performed by subjective, visual assessment. With the LIH reagent, this assessment can be performed objectively on the Beckman Coulter AU Chemistry System, providing higher quality analysis.

Test: Multiplex Chemokine Panel (TARC, MIP-1alpha, MCP-1, MDC, MCP-4 and IP-10)
Clinical Significance: Chemokines function by activating specific G protein-coupled receptors resulting in migration of inflammatory and non-inflammatory cells. The pro-inflammatory chemokines are responsible for migration of immune cells to the infection site, while the homeostatic chemokines are responsible for recruiting cells for tissue maintenance and development. Chemokines are associated with a number of diseases, including rheumatoid arthritis, Alzheimer’s disease, asthma, atherosclerosis, allergies, systemic lupus erythematosus, cancer, multiple sclerosis, atopic dermatitis, and chronic obstructive pulmonary disease.

Test: Multiplex Cytokine Panel (IL-1α, TNF-β, IL-17a, GM-CSF, IL-5, IL-7, IL-12/IL-23p40, and IL-15)
Clinical Significance: Cytokines are important in inflammation response and immune system regulation as well as numerous other biological processes. These cytokines are associated with a number of diseases, including rheumatoid arthritis, Alzheimer’s disease, asthma, various autoimmune diseases, allergies, systemic lupus erythematosus, obesity, cancer, depression, multiple sclerosis, diabetes, psoriasis, and Crohn’s disease.

Test: S100
Clinical Significance: S100 measurements are utilized to aid in the management of patients suffering from malignant melanoma and in the management of patients after brain injury in conjunction with clinical information and imaging techniques. Several members of the S-100 protein family are useful as markers for certain tumors and epidermal differentiation. It can be found in melanomas, 50% of malignant peripheral nerve sheath tumors, schwannomas, paraganglioma stromal cells, and clear cell sarcomas.

Test: Th17 panel (IL-23 and MIP-3 alpha)
Clinical Significance: The Th17 panel measures 2 cytokines that are important in the Th17 pathway.Th17 cells are a critical part of the immune system and act as a bridge between innate and adaptive immune systems. Improper regulation of their proinflammatory activities contributes to numerous pathogenic conditions such as rheumatoid arthritis, psoriasis, type 1 diabetes, multiple sclerosis, Crohn’s disease, and asthma. The Th17 biomarkers validated include IL-23 and MIP-3α.

Test: Type III erythrocytes and Type III granulocytes and monocytes
Clinical Significance: Paroxysmal nocturnal hemoglobinurea (PNH) is a form of hemolytic anemia caused by an inability to synthesize glycosylphosphatidylinositol (GPI) – anchored membrane proteins. Such proteins protect cells from complement mediated destruction. Type III erythrocytes, granulocytes, and monocytes are cells that lack glycosylphosphatidylinositol (GPI) – anchored membrane proteins. Identification of Type III erythryocytes, granulocytes, and monocytes by flow cytometry can be used to diagnose PNH and monitor the course of the disease.

Test: Urine Beta Crosslaps CTX-1
Clinical Significance: BETA crosslaps are degradation products of C-terminal telopeptides of Type-I collagen. The measurement of BETA crosslaps in human urine is used as an indication of human bone resorption. This test aids in monitoring bone resorption changes in anti-resorptive therapies in postmenopausal women as well as in predicting skeletal responses (bone mineral density) in postmenopausal women undergoing anti-resorptive therapies.

All Assays are Developed Based on CLSI Guidelines

The central lab validates all assays based on guidelines from the Clinical and Laboratory Standards Institute (CLSI) and in accordance with CAP and CLIA regulations. In addition, all validated assays meet the FDA guidance for bioanalytical method validation.

Click here to review the full list of our validated assays.

To learn more about Medpace’s central laboratories and how our recent expansion can benefit your next clinical trial, contact us here.