New Cancer Diagnostic Primed to Change the Industry

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NEW YORK, NY and Vancouver – BioMark Diagnostics (BUX:CNX) (FSE:20B) (BMKDF) — The ultimate goal in the cancer diagnostics sector is to establish an assay that is capable of detecting tumors before they become disruptive, metastatic and symptomatic. For the past forty years, the development of such an assay has been the holy grail of researchers, both in academia and industry. Although many breakthrough diagnostics have been invented such as ELISA-based assays, molecular biotechnology, genomic screening and advanced imaging, each have considerable limitations related to safety, biomarker accessibility, reproducibility and patient discomfort from invasive tissue sampling.

A new and promising approach to develop an ultra-early and non-invasive strategy implements discovery platforms for enzymes that are over-expressed in cancer cells. These enzymes are capable of producing high concentrations of metabolites that can be detected above and beyond traditional biomarkers.

BioMark Diagnostics, a Vancouver-based company, has used this metabolomics approach to identify such an enzyme called spermidine/spermine N1-acetyltransferase (SSAT). SSAT is capable of specifically converting an FDA approved drug called amantadine into a detectable form called N-acetylamantadine. This reaction occurs at much higher levels in cancer cells and the N-acetylamantadine metabolite is excreted in urine for endpoint analysis. This assay is capable of detecting pre-visible tumors that are ~1/100 the size of the period at the end of this sentence.

Q: As a breakthrough technology, do you feel the assay will replace existing detection methods and standards?

A: BioMark and the Medical Community in general will always search to improve current methods of detection. Current practice will continue to rely on “standards”. However, when one investigates the diagnostic power of existing detection methods there is much room for improvement. BioMark is confident that its assay will significantly amplify the diagnostic power of the existing state of the art. Importantly, our team envisions our assay as a primary assay with existing detection methods supplementing ours.

Q: How long does the assay take from sample collection to diagnosis?

A: Our current technology is approved by Health Canada for use with Liquid Chromatography tandem Mass Spectroscopy (LC-MS/MS) where results can take from 2 hours to 1 day turnarounds. Although the results of LC-MS/MS are indisputable, BioMark recognized early on that, if we were to realize our broader objectives of “labs to villages”, it was necessary to move towards more rapid detection methods. As such, BioMark has spent considerable time, effort and money to innovate easier-to-use, more rapid and economical detection methods starting with our soon-to-be-released ELISA and ICT kits. These advancements will offer point of care utility for patients and clinicians.

Future developments include our break-through technology in the biophotonics sector utilizing Surface Enhanced Raman Spectrometry (SERS). This novel application of Raman Spectroscopy to help with cancer detection is an exciting example of how the biophotonics industry will make significant contributions to Life Sciences. Even more important is our continued efforts to innovate a paper-SERS (p-SERS) application that will allow our vision of “labs to villages” with LC-MS/MS-like results being realized with easy-to-use, hand-held equipment. This technology break-through will allow the large population and underserved market places in the low and low-to-medium income countries access to appropriate cancer detection technologies.

Q: What is the mortality rate associated with very early detection of cancers and do you believe that this assay will further reduce this rate.

A: Over 50% of cancers are curable if caught early. Unfortunately, current limits of detection are not allowing for very early stage cancer detection. BioMark’s technology has clinical evidence of detecting pre-visible and pre-symptomatic cancers. In one unsolicited testimony of a Canadian oncologist, our technology has the opportunity to make advanced lung cancer “obsolete”. The US Preventive Service Task Force has published a draft recommendation that patients at high-risk of lung cancer have CT scans for early-stage disease. The decision could lead to screening of thousands of people in the hope of curbing deaths from lung cancer. Mortality from lung cancer is high in the USA. The disease kills about 160,000 people per year: more than any other cancer. Early detection is rare, yet early diagnosis could greatly improve 5-year survival – at present, a mere 16% in the USA. BioMark knows it can play a pivotal role in this particularly devastating disease.

Q: What is the most noticeable success related to the assay from clinical trials results?

A: Our chief scientists and technologists noticed a clear signal that the assay can detect cancer in the earliest stages and we have proven the science and established clinical trials success. Additionally BioMark has completed protocols related to:

  • Response to treatment initially related to lung cancer.
  • Cancer survivorship programs – offer patients effective remote monitoring capability for potential relapse alert.

Q: What do you feel that BioMark’s next and most important move into the United States will entail?

A: Our recent move to an OTCQB listing should allow us to realize our mid-term goal of gaining a significant shareholder base in USA and ultimately be approved to list on NASDAQ. To support this financial milestone BioMark realizes the critical nature of selecting proper locations for gaining presence in USA. We have been invited by the Canadian Government to consider locations in Boston and San Francisco as important footholds in USA. Although our exploration of Boston was encouraging, BioMark will follow its’ incorporation in Delaware with setting up offices in Maryland and in Silicon Valley of California. We have chosen Maryland due to the proximity to the University of Maryland, John Hopkins and the National Cancer Institute and the FDA.

For more information on BioMark Diagnostics cutting edge cancer detection assay, read the Biotech Bulletin at – www.criterionbioscience.com

Criterion BioScience is a news group that only evaluates the best up and coming companies that we feel will profoundly influence the biotechnology and pharmaceutical industries. We differ from all other news resources, such that our analyses are conducted by research doctors who are renowned in the respective field of the evaluation.

Produced and Published by CriterionBioscience.com

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