VANCOUVER, British Columbia, Feb. 16, 2016 (GLOBE NEWSWIRE) -- BioMark Diagnostics Inc. (“BioMark”) (CSE:BUX) (FSE:20B) (OTCQB:BMKDF) announces that BioMark has completed the internal standards for its assay to meet both Health Canada and FDA requirements for the 200 patient trial completed in Fall of 2015.
Rashid Ahmed, CEO and President of BioMark, states that, “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 (SBRC) 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. (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.
About 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 NDAenabling 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. More information is available at www.biomarkdiagnostics.com.
Further information about BioMark Diagnostics is available under its profile on the SEDAR website www.sedar.com and on the CSE website www.thecse.ca.
Forward-Looking Information:
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. This news release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein in the United States. The securities described herein have not been and will not be registered under the United States Securities Act of 1933, as amended, or any applicable securities laws or any state of the United States and may not be offered or sold in the United States or to the account or benefit of a person in the United States absent an exemption from the registration requirements.
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