Abstract:
BACKGROUND:The promise of targeted therapies in molecularly defined subsets of cancer has led to a transformation of the process of drug development in oncology. To target cancer successfully and precisely requires high-quality translational data. Such data can be generated by the use of biomarkers that answer key questions in drug development. CONTENT:Translational data for aiding in decision-making and driving cancer drug development can be generated by systematic assessments with biomarkers. Types of biomarkers that support decisions include: pharmacodynamic assessments for selecting the best compound or dosage; assessment of early tumor response with tissue biomarkers and imaging, mutation, and other assessment strategies for patient selection; and the use of markers of organ injury to detect toxicity and improve safety. Tactics used to generate biomarker data include fit-for-purpose assay validation and real-time biomarker assessments. Successfully translated and clinically informative biomarkers can mature into novel companion diagnostic tests that expand the practice of laboratory medicine. SUMMARY:Systematic biomarker assessments are a key component of the clinical development of targeted therapies for cancer. The success of these biomarker assessments requires applying basic principles of laboratory medicine to generate the data required to make informed decisions. Successful biomarkers can transition into diagnostic tests that expand the laboratory medicine armamentarium.
journal_name
Clin Chemjournal_title
Clinical chemistryauthors
Modur V,Hailman E,Barrett JCdoi
10.1373/clinchem.2012.191072subject
Has Abstractpub_date
2013-01-01 00:00:00pages
102-9issue
1eissn
0009-9147issn
1530-8561pii
clinchem.2012.191072journal_volume
59pub_type
杂志文章,评审abstract:BACKGROUND:The recent interest of clinical laboratories in developing serum testosterone assays based on isotope dilution-liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) stems from the lack of accuracy of direct immunoassays. In this study, we assessed the accuracy and state of standardization (traceabilit...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2008.105841
更新日期:2008-08-01 00:00:00
abstract:BACKGROUND:Evidence suggests that systemic inflammation may adversely impact HDL function. In this study we sought to evaluate the independent and incremental predictive performance of GlycA-a novel serum inflammatory biomarker that is an aggregate measure of enzymatically glycosylated acute phase proteins-and HDL subc...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2016.261636
更新日期:2017-01-01 00:00:00
abstract::This method for determining aluminum in human serum involves electrothermal atomic absorption spectrophotometry. A longer drying time allows less pre-dilution of the sample, and the method also includes a flush cycle after atomization. Standard-addition methodology is used to eliminate matrix effects and the need for ...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1983-06-01 00:00:00
abstract::We have improved the protocol for RNA quantification by using RNase protection. Instead of precipitation and extraction with phenol and chloroform, we use a faster and more reliable precipitation based on guanidinium thiocyanate (GdSCN). The internal standard is produced by in vitro transcription of a DNA template con...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:The analysis of bodily fluids using SELDI-TOF MS has been reported to identify signatures of spectral peaks that can be used to differentiate patients with a specific disease from normal or control patients. This report is the 2nd of 2 companion articles describing a validation study of a SELDI-TOF MS approa...
journal_title:Clinical chemistry
pub_type: 杂志文章,多中心研究
doi:10.1373/clinchem.2007.091496
更新日期:2008-01-01 00:00:00
abstract::The S-peptide and S-protein fragments of ribonuclease S (RNase S, no EC no. assigned) have been immobilized onto separate Sepharose gels via a "leash" of polycytidylic acid substrate. Each of these gels releases its RNase fragment when treated with the complementary enzyme fragment or with RNase A (EC 3.1.27.5), and t...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1986-09-01 00:00:00
abstract::We describe an automated enzymatic procedure for quantifying creatine in erythrocytes. In this assay, after sample clean-up, creatine kinase (CK; EC 2.7.3.2) and pyruvate kinase (EC 2.1.7.40) are used as auxiliary enzymes; lactate dehydrogenase (EC 1.1.1.27) is used in the indicator reaction. CK is also used as the st...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1996-02-01 00:00:00
abstract::Humans are exposed daily to low concentrations of many different chemical substances, natural and some man-made. Although many of these substances can be toxic at high levels, typical exposures are far below the effect levels. The responses produced by man-made aromatic hydrocarbon receptor agonists, such as dioxins, ...
journal_title:Clinical chemistry
pub_type: 杂志文章,评审
doi:
更新日期:1996-08-01 00:00:00
abstract::Using results from patients, we studied several methods for long-term (years) monitoring of the analytical stability of various chemistry tests. For each test, we obtained on a bimonthly basis histograms of > or = 200 to approximately 2000 data points and determined the median, mean, and mean of those data points in t...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1996-06-01 00:00:00
abstract::Genetic engineering of beta-galactosidase (EC 3.2.1.23) has led to the development of a new homogeneous assay system, CEDIA. The Z gene of the lac operon of Escherichia coli encodes a large enzymatically inactive polypeptide that spontaneously aggregates and folds to form active beta-galactosidase. Using recombinant D...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1986-09-01 00:00:00
abstract::We describe the influence of autoantibodies that bind creatine kinase BB (CK-BB) on the methods for MB isoenzyme. If these autoantibodies are present in patients' sera, they cause the formation of macro CK type 1 (immunoglobulin-linked CK-BB). In some of these cases they can bind not only endogenous CK-BB but also CK-...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1985-07-01 00:00:00
abstract:BACKGROUND:Two mutations in HFE, G845A (amino acid substitution C282Y) and C187G (H63D), are associated with hereditary hemochromatosis. We developed and validated a novel method, linked linear amplification (LLA), for detection of these two mutations. METHODS:Two segments of HFE were amplified by a multiplex LLA reac...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/49.7.1050
更新日期:2003-07-01 00:00:00
abstract::We evaluated a new, simple, enzymatic kinetic method from Wako Chemicals GmbH in comparison with a kinetic Jaffé method by using isotope dilution-mass spectrometry (ID-MS) as a reference method. An ID-MS-calibrated serum standard was used. Both the enzymatic and the Jaffé method correlated well with ID-MS, except for ...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1989-05-01 00:00:00
abstract:BACKGROUND:Monogenic autoinflammatory diseases are caused by pathogenic variants in genes that regulate innate immune responses, and are characterized by sterile systemic inflammatory episodes. Since symptoms can overlap within this rapidly expanding disease category, accurate genetic diagnosis is of the utmost importa...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1093/clinchem/hvaa024
更新日期:2020-04-01 00:00:00
abstract::In this simple and low-cost radioimmunoassay (RIA) procedure for thyroxin (T4), ethacridine (6,9-diamino-2-ethoxyacridine lactate; Rivanol) is used to separate antibody-bound ligand and free ligand. This acridine dye precipitates free T4 not bound to antibody. At pH 8.6, it precipitates more than 90% of 125I-labeled T...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1983-11-01 00:00:00
abstract::Hepatitis A virus (HAV) infection occurs worldwide and is an important cause of acute viral hepatitis in the US. In this review, I cover the epidemiology, course of infection, clinical manifestations, serological responses, and prevention of this infection. Although most patients completely recover from this disease, ...
journal_title:Clinical chemistry
pub_type: 杂志文章,评审
doi:
更新日期:1997-08-01 00:00:00
abstract:BACKGROUND:Standardization of hemoglobin (Hb)A(1c) measurements is a process of considerable interest for quality assurance in diabetes management. To contribute to continuous quality improvement and fulfillment of the requirements for reference measurement procedures according to the standards of the International Org...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2009.139477
更新日期:2010-05-01 00:00:00
abstract::Imferon (Merrell-National), an iron-dextran complex, is widely used in patients with iron deficiency. It is present in the circulation in appreciable amounts for two to three weeks after administration and interferes with all tested colorimetric iron assays, both with and without deproteinization. The amount of the pl...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1980-04-01 00:00:00
abstract:BACKGROUND:Methylmalonic acid (MMA) in plasma or serum is widely used for assessment of vitamin B(12) status. However, data are sparse regarding factors, besides renal function, that may influence MMA concentrations. We searched for important determinants of plasma MMA in the general population. METHODS:In 6946 middle...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2009.128678
更新日期:2009-12-01 00:00:00
abstract:BACKGROUND:Standardization of clinical measurements of C-reactive protein (CRP) is based on the availability of reference materials. The serum protein reference material ERM-DA470 was used as a calibrant for various commercially available immunoassays but has now been exhausted. The recently released ERM-DA470k/IFCC wa...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2010.147124
更新日期:2010-09-01 00:00:00
abstract::We present data on a filter-paper collection and assay method for measurement of glycated hemoglobin (gHb). Onto filter paper dipped into a solution of glucose oxidase (EC 1.1.3.4) and allowed to dry, approximately 20 microL of capillary blood was spotted. For analysis, we eluted the dried blood spot from the paper by...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1986-05-01 00:00:00
abstract::Methods for measuring thyroid autoantibodies--to thyroperoxidase (TPOAb), thyroglobulin (TgAb), and thyrotropin receptor (TRAb)--have improved over the last decade, but increasingly, accurate and sensitive methods are needed for identifying patients with autoimmune thyroid diseases and individuals at high risk for ons...
journal_title:Clinical chemistry
pub_type: 杂志文章,评审
doi:
更新日期:1996-01-01 00:00:00
abstract::Measured triglyceride concentrations were extremely low (less than 100 mg/L) in the serum of some patients who were receiving hydroxyurea for myeloproliferative diseases. The assay being used to quantify triglycerides was a "cascaded" enzymatic method involving (a) lipase, to generate glycerol from triglycerides; (b) ...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1985-08-01 00:00:00
abstract::We report the first solid-phase radioimmunoassay for triiodothyronine with use of antibody-coated tubes, which is designed specifically for the fully automated radioimmunoassay instrument, Micromedic Systems' "Concept 4 Automatic Radioassay." Antisera to triiodothyropropionic acid/bovine serum albumin were raised in r...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1977-05-01 00:00:00
abstract:BACKGROUND:Diagnosis of mitochondrial disorders usually requires a muscle biopsy to examine mitochondrial function. We describe our diagnostic procedure and results for 29 patients with mitochondrial disorders. METHODS:Muscle biopsies were from 43 healthy individuals and 29 patients with defects in one of the oxidativ...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2005.062414
更新日期:2006-05-01 00:00:00
abstract::We describe a modified tantalum ribbon atomic absorption procedure for determining lead in undiluted whole blood. An instrumentation Laboratory (I.L.) Model 151 atomic absorption spectrophotometer equipped with an I.L. Model 355 Flameless Sampler was used. The Flameless Sampler was slightly modified to include three-c...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1978-07-01 00:00:00
abstract::We investigated two techniques of immunoblotting--the Western blot and the dot blot--for use in detecting prostatic acid phosphatase (PAP, EC 3.1.3.2). We used polyclonal antisera to human PAP, produced in rabbits by hyperimmunization with purified PAP, and PAP-specific monoclonal antibodies in the immunoenzymatic pro...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1986-10-01 00:00:00
abstract::Methods are described for detection of lactate dehydrogenase (LDH) inhibitors in preparations of reduced nicotinamide adenine dinucleotide. They are (a) comparison of values by kinetic methods with those measured for highly purified NADH and (b) examination of Lineweaver-Burk plots. Chromatographic inhomogeneities are...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:
更新日期:1976-10-01 00:00:00
abstract:BACKGROUND:The single cell represents the basic unit of all organisms. Most investigations have been performed on large cell populations, but understanding cell dynamics and heterogeneity requires single-cell analysis. Current methods for single-cell analysis generally can detect only one class of analytes. METHODS:Re...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2012.191445
更新日期:2012-12-01 00:00:00
abstract:BACKGROUND:Calcitonin (CT) is a sensitive marker for evaluation of medullary thyroid cancer (MTC). However, CT measurement can vary with assay- and nonassay-dependent factors, and procalcitonin (PCT) measurement has been proposed for evaluating questionable increases in CT. METHODS:We tested 2 fully automated CT assay...
journal_title:Clinical chemistry
pub_type: 杂志文章
doi:10.1373/clinchem.2010.151688
更新日期:2011-03-01 00:00:00