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Biomark receives Health Canada testing authorization

2014-12-08 08:06 ET - News Release

Mr. Rashid Ahmed reports

BIOMARK RECEIVES HEALTH CANADA PROTOCOL APPROVAL

Biomark Diagnostics Inc. has been granted an investigational testing authorization by Health Canada's Therapeutic Products Directorate adopting the company's protocols and reference standards for reference laboratories across Canada. The authorization also will allow Biomark to sell up to 180 of these devices as part of the ITA for investigational purposes. The ITA recognizes the proprietary protocol the company has developed and internationally patented for urinary excretion of acetylamantadine by cancer patients. This protocol involves the use of Biomark's acetylamantadine assay standard for liquid chromatography -- tandem mass spectrometry (LC-MS/MS). This assay was developed by Biomark in order to establish a clinical diagnostic reference standard as part of the protocol when evaluating urinary excretion of acetylamantadine as a predication cancer presence.

President and chief executive officer of Biomark, Rashid Ahmed, commented: "This is a necessary achievement for Biomark since we utilized industry gold standard using LC-MS/MS. The authorization provides Biomark the ability to conduct tests for validating the use of our internal system for labs and sets the stage for licensing later."

The regulatory submission and documentation were guided by the regulatory team at St. Boniface Hospital Research Centre.

We seek Safe Harbor.

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