Development of novel IVD assays: A manufacturer's perspective

Metcalfe, Thomas

doi:10.3109/00365513.2010.493361

Cited by 9 publications

(8 citation statements)

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“…This requires not only that all the test characteristics previously described are satisfactorily met but also that the development costs of automation will ultimately be recouped and provision of the test will be financially profitable. Some reworking of the test may be required to ensure that it runs optimally on the platform 33 and provides results identical to those obtained with earlier manual assays. As discussed above, regulatory aspects are critical and a clinical trial using the assay in its final form is usually necessary 33.…”

Section: Transition Of a New Biomarker From Research To Routinementioning

confidence: 99%

“…Some reworking of the test may be required to ensure that it runs optimally on the platform 33 and provides results identical to those obtained with earlier manual assays. As discussed above, regulatory aspects are critical and a clinical trial using the assay in its final form is usually necessary 33.…”

Section: Transition Of a New Biomarker From Research To Routinementioning

confidence: 99%

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Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

Sturgeon

Hill

Hortin

et al. 2010

Proteomics Clinical Apps

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There is increasing pressure to provide cost-effective healthcare based on “best practice.” Consequently, new biomarkers are only likely to be introduced into routine clinical biochemistry departments if they are supported by a strong evidence base and if the results will improve patient management and outcome. This requires convincing evidence of the benefits of introducing the new test, ideally reflected in fewer hospital admissions, fewer additional investigations and/or fewer clinic visits. Carefully designed audit and cost-benefit studies in relevant patient groups must demonstrate that introducing the biomarker delivers an improved and more effective clinical pathway. From the laboratory perspective, pre-analytical requirements must be thoroughly investigated at an early stage. Good stability of the biomarker in relevant physiological matrices is essential to avoid the need for special processing. Absence of specific timing requirements for sampling and knowledge of the effect of medications that might be used to treat the patients in whom the biomarker will be measured is also highly desirable. Analytically, automation is essential in modern high-throughput clinical laboratories. Assays must therefore be robust, fulfilling standard requirements for linearity on dilution, precision and reproducibility, both within- and between-run. Provision of measurements by a limited number of specialized reference laboratories may be most appropriate, especially when a new biomarker is first introduced into routine practice.

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Section: Transition Of a New Biomarker From Research To Routinementioning

confidence: 99%

Section: Transition Of a New Biomarker From Research To Routinementioning

confidence: 99%

Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

Sturgeon

Hill

Hortin

et al. 2010

Proteomics Clinical Apps

View full text Add to dashboard Cite

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“…In the case of MONET1, the study protocol amendment was discussed with both drug and diagnostics divisons of the US Food and Drug Administration (FDA). Its approval through the FDA’s Special Protocol Assessment; agreement with the FDA on assay performance and testing; and development of an in vitro diagnostic (IVD) assay that was reliable, robust, and easily implemented in a clinical setting [38] , all had to take place before the event trigger for the primary analysis. Development of the IVD assay also necessitated validation of the phase 2 PLGF results using the follow-on ARCHITECT assay system to ensure that the association between fold-change in PLGF and OS remained when using the new companion diagnostic.…”

Section: Discussionmentioning

confidence: 99%

Challenges in Developing a Validated Biomarker for Angiogenesis Inhibitors: The Motesanib Experience

et al. 2014

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PurposeWe sought to develop placental growth factor as a predictive pharmacodynamic biomarker for motesanib efficacy as first-line therapy in patients with advanced nonsquamous non–small-cell lung cancer.Experimental DesignPlacental growth factor was evaluated at baseline and study week 4 (after 3 weeks treatment) in an exploratory analysis of data from a randomized phase 2 study of motesanib 125 mg once daily plus carboplatin/paclitaxel and in a prespecified analysis of data from a randomized, double-blind phase 3 study of motesanib 125 mg once daily plus carboplatin/paclitaxel vs placebo plus carboplatin/paclitaxel (MONET1). Associations between fold-change from baseline in placental growth factor and overall survival were evaluated using Cox proportional hazards models.ResultsIn the phase 2 study, serum placental growth factor increased from baseline a mean 2.8-fold at study week 4. Patients with ≥2.2-fold change from baseline in placental growth factor (n = 18) had significantly longer overall survival than those with <2.2-fold change (n = 19; 22.9 vs 7.9 months; hazard ratio, 0.30; 95% CI, 0.12–0.74; P = 0.009). Consequently, placental growth factor was investigated as a pharmacodynamic biomarker in the phase 3 MONET1 study. There was no association between log-transformed placental growth factor fold-change from baseline to week 4 (continuous variable) and overall survival (hazard ratio, 0.98; 95% CI, 0.79–1.22; P = 0.868). MONET1 did not meet its primary endpoint of overall survival. Likewise, median overall survival was similar among patients with ≥2.0-fold change in placental growth factor (n = 229) compared with <2.0-fold change (n = 127; 14.8 vs 13.8 months; hazard ratio, 0.88; 95% CI, 0.67–1.15, P = 0.340).ConclusionsOur results illustrate the challenges of successfully translating phase 2 biomarker results into phase 3 studies.Trial RegistrationClinicalTrials.gov NCT00460317, NCT00369070

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“…When considering requirements for the successful introduction of new diagnostic tests, it is helpful to review the general criteria that must be met (see Table 1), focusing on the roles of both research and specialist laboratories and the somewhat different requirements of high- throughput routine laboratories [61-64]. …”

Section: Considerations and Future Needsmentioning

confidence: 99%

Clinical proteomics and OMICS clues useful in translational medicine research

et al. 2012

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Since the advent of the new proteomics era more than a decade ago, large-scale studies of protein profiling have been used to identify distinctive molecular signatures in a wide array of biological systems, spanning areas of basic biological research, clinical diagnostics, and biomarker discovery directed toward therapeutic applications. Recent advances in protein separation and identification techniques have significantly improved proteomic approaches, leading to enhancement of the depth and breadth of proteome coverage.Proteomic signatures, specific for multiple diseases, including cancer and pre-invasive lesions, are emerging. This article combines, in a simple manner, relevant proteomic and OMICS clues used in the discovery and development of diagnostic and prognostic biomarkers that are applicable to all clinical fields, thus helping to improve applications of clinical proteomic strategies for translational medicine research.

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Development of novel IVD assays: A manufacturer's perspective

Cited by 9 publications

References 0 publications

Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

Challenges in Developing a Validated Biomarker for Angiogenesis Inhibitors: The Motesanib Experience

Clinical proteomics and OMICS clues useful in translational medicine research

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