Vancouver, British Columbia – (January 3rd, 2018) – BioMark Diagnostics Inc. (“BioMark”) (CSE: BUX, FSE: 20B, OTCMKTS: BMKDF) is pleased to provide further progress on its clinical trial activities as previously reported on November 1st, 2017.
New accomplishments over the past few weeks are listed below.
- Samples from the outlier cohort have been received at Biopharmaceutical Research Inc. (BRI) in Vancouver where they are being analyzed under Good Laboratory Practice utilizing Health Canada Investigational Testing Authorization standards granted to BioMark under application # 229838. (Outliers are subjects who were considered healthy, but exhibited higher than expected Acetyl Amantadine concentrations). BRI received the customized reference standard material from United States that is used to calibrate the equipment following a delay in manufacturing. BRI anticipates that it will now require about 2 weeks to complete analysis and data tabulation for the biostatisticians in Manitoba to review.
- A comprehensive medical follow-up report of the outliers in both in Canada and Bangladesh is being reviewed by Dr. Andrew Maksymuik, the Principal Investigator at CancerCare Manitoba along with our scientists and regulatory team members from St. Boniface Hospital Research Center. A good assessment report of the outliers would demonstrate that BioMark’s SSAT1 technology can provide physicians a definitive diagnostic tool to cost effectively prescreen patients for either more expensive CT screening or more invasive biopsy procedure. In addition, the medical follow-up report will be useful as part of the submission package to be filed with Health Canada.
Next Steps
BioMark continues to work with all the parties to ensure that all the data is received and tabulated for a comprehensive submission package to Health Canada as soon as possible after the completion of the new incoming data analysis and reports. The regulatory group has begun to compile elements of the submission package to Health Canada.
News Release – Further Progress on BIOMARK’s Clinical Trial and Regulatory Review