VANCOUVER, BRITISH COLUMBIA--(Aug. 19, 2015) - BioMark Diagnostics Inc. ("BioMark" or the "Company") ($BUX:CNX) (FRANKFURT:20B)($BMKDF), a leader in next-generation diagnostics using metabolites, is pleased to announce that the assay validation to analyze the clinical samples from the Company's first 200-patient trial is anticipated to be completed within four weeks.
The internal standard for the assay analysis was established by Biopharmaceutical Research Inc. (BRI), and meets U.S. Food and Drug Administration (FDA) 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.
"We conducted this trial to build on our proven ability and clinical success in using a simple urine sample to accurately diagnosis cancer in its very early stages," said BioMark President and CEO Rashid Ahmed. "Trial samples will be analyzed and data generated after the assay validation is completed. It is vitally important to have a rigorous standard established that meets and exceed regulatory requirements. BRI offers third-party validation services under a GLP/GMP environment and the results can be reliably presented for regulatory applications in the U.S. and Canada. Completion of this phase is critical in generating data that can be submitted to Health Canada and later to FDA for final approval."
About Biopharmaceutical Research Inc. (BRI)
BRI Biopharmaceutical Research Inc. is a specialized analytical, bioanalytical and drug metabolism and pharmacokinetic (DM/PK) contract research organization (CRO) servicing pharmaceutical and biotechnology companies in discovery, preclinical and clinical programs supporting IND and NDA-enabling studies.
The bioanalytical LC/MS/MS group was founded by Dr. David Kwok and has been operating since 1999. Over the years BRI has performed hundreds of quantitative assays on small molecule drugs, metabolites and chemical biomarkers supporting Phase I to IV clinical PK samples and DM/PK preclinical samples. Bioanalytical assay experience includes immunochemical ELISA and cell-based assays of small molecule chemical biomarkers and large molecules.
BRI meets the following Good Laboratory Practice Regulations/ Standards/ Guidelines:
- U.S. Food and Drug Administration, Title 21 Code of Federal Regulations Part 58, Current
- Organization for Economic Cooperation and Development
- The OECD Principles of Good Laboratory Practice, Series on Principles of Good Laboratory Practice and Compliance Monitoring, Monograph No.1 to 14, current
- Japanese Ministry of Health and Welfare, Ordinance No. 21, April 1, 1997
About BioMark Diagnostics Inc.
BioMark Diagnostics is developing proprietary, non-invasive, and accurate cancer diagnostic solutions, which can help detect, monitor and assess treatment for cancer early and cost effectively. The technology can also be used for measuring response to treatment and potentially for serial monitoring for cancer survivors.
This press release may include forward-looking information within the meaning of Canadian securities legislation, concerning the business of BioMark. Forward-looking information is based on certain key expectations and assumptions made by the management of BioMark. Although BioMark believes that the expectations and assumptions on which such forward-looking information is based are reasonable, undue reliance should not be placed on the forward-looking information because BioMark can give no assurance that they will prove to be correct. Forward-looking statements contained in this press release are made as of the date of this press release. BioMark disclaims any intent or obligation to update publicly any forward-looking information, whether as a result of new information, future events or results or otherwise, other than as required by applicable securities laws.
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