Abstract
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Tovagene’s Trovera EGFR urine liquid biopsy test will be used in an open-label prospective biomarker study by Astra-Zeneca (AZ) designed to evaluate whether 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 indicated 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 oncology 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 marketing CLIA services directly to medical professionals.