Clinical OMICS

JUL-AUG 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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38 Clinical OMICs July/August 2017 www.clinicalomics.com AstraZeneca to Assess Trovagene's EGFR Urine- Based Liquid Biopsy Tovagene's Trovera EGFR urine liquid bi- opsy test will be used in an open-label prospective biomarker study by Astra- Zeneca (AZ) designed to evaluate wheth- er the combination of noninvasive urine and blood testing is as effective as tissue testing in identifying epidermal growth factor receptor (EGFR) T790M mutation status. The agreement, whose value was not disclosed, comes in the wake of FDA approval for AZ's Tagrisso (osimertinib) 80 mg once-daily tablets. Tagrisso is indi- cated as a treatment for metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) as detected by an FDA -approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. The agreement with AstraZeneca comes some six months after Trovagene completed a reorganization designed to increase its focus on global distribution of kits and systems to clinical research laboratories for the liquid biopsy on- cology testing market. Trovagene said the reorganization would enable it to save approximately $4 million per year in pre-tax expenses, mainly through the elimination of 20 jobs and cutting back on expenses associated with mar- keting CLIA services directly to medical professionals. n In the Lab Scientific instrumentation company Bruker, announced a new solution for the analysis and quantification of metabolites from urine samples using Nuclear Magnetic Resonance (NMR) at the Metabolomics Society Meet- ing 2017. Bruker developed the new B.I.QUANT-UR module to accompany their 600-MHz NMR platform Avance IVDr (In Vitro Diagnostics research). Although the technology has only been released for research purposes, it has the potential to provide predictive disease detection and management for the myriad of diseases that affect urine metabolites including diabetes, met- abolic syndrome, obesity, kidney dis- ease, and cancer. According to Manfred Spraul, Ph.D., CTO of the applied, industrial and clinical division at Bruker BioSpin, "The reproducibility of NMR, which is unmatched by any other technology, allows us to see very subtle effects [on metabolite concentrations]." The metabolite concentrations pres- ent in urine can vary substantially both between individuals and within the same individual at different time points. Diet, disease, exercise, and environmental conditions can all affect the metabolites excreted in urine. While these variables can make urine metabolic analysis complex, they also make it an information-rich resource with a large number of applications. Instead of a single biomarker, NMR can use the complex patterns of metabolite concentrations as a spectral fingerprint for different diseases. "You will of course see large concentrations of any metabolite, but you will also see slight changes of several metab- olites at the same time—which is dif- ficult for other analytical methods" explained Dr. Spraul. Scientists and clinicians can exam- ine a broad array of health-related factors through the lens of metabolic profiles, which have the potential to save lives and lower healthcare costs by enabling better healthcare manage- ment and earlier disease treatment. The automated B.I.QUANT-UR module provides reproducible quanti- fication of up to 150 different metab- olites in urine at a rate of 80 to 100 samples per day, with specific versions for children/adults and neonates that account for the substantial differences in the ionic matrix of these samples to allow both targeted and non-targeted approaches. The new module will expand upon Bruker 's current portfolio of tools for the Avance IVDr, which also includes a module for lipopro- tein subclass analysis from serum or plasma called B.I.LISA as a rapid alternative to ultracentrifugation and chromatographic methods. —Meghaan Ferreira Bruker Launches Advanced Urine Metabolite Analysis Module blueringmedia / Getty Images

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