BioMark Diagnostics, 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. (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."
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.