Mr. Rashid Ahmed reports
BIOMARK ANNOUNCES PROGRESS TOWARDS DATA ANALYSIS
Biomark Diagnostics Inc. has completed the internal standards for its assay to meet both Health Canada and Food and Drug Administration requirements for the 200-patient trial completed in the fall of 2015.
Rashid Ahmed, chief executive officer and president of Biomark, stated: "Data transfer agreement form from BRI regarding the data from the urinary analysis of N-acetylamantadine of the study samples is expected to be signed between Saint Boniface Research Centre by middle of February, 2016. Saint Boniface's unit statistician will perform appropriate statistical analyses and will generate a report for Biomark's scientific and regulatory team to review. It is expected to take approximately 10 weeks to complete the analysis and to generate a report. Submission to Health Canada will follow pending the robustness of the data. All the submission work will be led by SBRC team based in Manitoba."
Standards
The internal standard for the assay analysis was established by Biopharmaceutical Research Inc. and meets United States Food and Drug Administration and Health Canada requirements. The trials were conducted in Canada and Bangladesh and focused on lung, breast and GI cancers. Assay validation methods are completed to ensure that an analytical methodology is accurate, specific and reproducible over the specified range that a target will be analyzed. Assay validation provides an assurance of reliability during normal use.
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