by Deborah Bacal from proactiveinvestors.com

BioMark (CSE:BUX) has in its hands a diagnostic test that can detect cancer at an early stage, disrupting the current diagnostic market for the disease as we know it and making it easier for both patients and doctors alike.

The metabolomics-based test consists of a single, one-shot application of Amantadine, a drug which is already approved in both the US and Canada, after which a urine sample is collected two to four hours later and then analyzed.

The non-invasive test, using a sophisticated LC-MS machine, is screening for high levels of the acetylated form of the drug. The acetylation is performed by an enzyme, known as SSAT, which has been proven to be present in elevated levels in many cancers including lung, breast, prostate, melanoma and gastrointestinal tract.

“This enzyme is always present in all mammalian cells. The difference is that cancer patients have a higher proportion of the enzyme than healthy subjects,” says chief executive officer Rashid Ahmed.

The company has validated its work with various clinical trials, as well as with literature published at the National Cancer Institute and other leading scientific publications.

“[The test] could work for many kinds of cancers,” explains Ahmed, “but we are specifically looking at cancers that have the most significant impact on the most patients. SSAT is highly up-regulated in breast, lung, GI and prostate cancers.” In tumor cells, SSAT is “upregulated”, the process by which there is a cellular increase in the number of receptors to a molecular stimulus.

Ahmed was drawn to the technology, which has its origins in a Canadian university, from his own life experience, as his sister was diagnosed with cervical cancer in 2006 at a very late stage and was given just six months to live — an event which he calls a “turning point” in his life. According to recent stats, some 90 percent of cancers are curable if caught early.

He says lung cancer is a special area of focus for BioMark, given that the disease is often diagnosed at a stage that is too late for any promising chance of recovery. The idea behind the test is to allow doctors to screen high risk patients such as smokers and ex smokers, bringing them to the front of the line and saving hospitals both time and money. In North America, there are over 95 million smokers and ex smokers.

“A low dose CT scan costs around $1,000 in North America and it takes up a physician’s time, nurse time and set-up time. Our test could help narrow down the people who might benefit most from CT scanning or even be complementary to population-based screening recommendations. As well in many places around the world, CT scans are scarce.”

Phase 3 trials are already underway in Manitoba, Canada and in Bangladesh, with Ahmed saying he is looking to go into the US and China as well, areas with bigger populations where it is easier to attract patients. The company has some 200 patients enrolled in Bangladesh, and 140 in Canada, with plans to extend the trials by about 500 subjects down the road on an ongoing basis.

Once the company has results in hand, expected this year, the plan is to bring the data to Health Canada and the US FDA to attain formal approvals.

BioMark’s diagnostic technology was initially licensed from the University of Manitoba as single patent, which has already been expanded to include other detection technologies within its area of interest.

After receiving its investigational testing authorization (ITA) from Health Canada, the company has the authorization to provide its test to sites like LifeLabs, which has 280 patient care centres across Canada. “It’s easy for them to work with us. We provide a package and once patients go to LifeLabs to do the test, the urine is sent off for analysis using our internal standards that we have developed,” says BioMark’s CEO.

Another market for the diagnostic test is a point-of-care system targeting existing cancer survivors, with some 15 million estimated across North America currently. BioMark’s test may allow cancer survivors to screen for the disease affordably in their homes, providing them with immediate monitoring capabilities. The concept would turn the idea of early detection on its head, essentially empowering an individual’s ability to detect cancer at home and seek earlier intervention.

“Recurrence happens quite frequently with cancer and the first five years are critical,” explains Ahmed. “Once patients see an increase in the enzyme, the red flag info can be transported directly to the doctor,” he added.

BioMark, says the CEO, is the only company using a therapeutic agent for diagnostic indication, acting as a smart probe that is “very selective to the tumor.”

“Once this enzyme is in your body, it circulates back and forth. It doesn’t recycle. It’s a real clear signal.”

The chief executive officer reckons that the point-of-care system could be worth a few hundred million to a billion dollars depending on how many tests a patient performs.

The third potential market for BioMark is to analyze the SSAT enzyme levels to determine the specific cancer type. By combining its unique urine-based system with sophisticated data analysis, BioMark will develop a general cancer screening tool to enable the early detection of specific types of cancers.

“We are strategically working with the right medical institutions, incorporating the right patients into our study and working with lab companies that have the infrastructure to deploy our tests. We are making sure we are at the forefront, and transparent with regulators,” affirms Ahmed.

Indeed, the company has strategic collaborations with five universities in Canada, as well as relationships in China, Malaysia, Bangladesh and the US, including University of Maryland.

BioMark is looking forward to a number of milestones in 2015, including a listing of its stock on the OTCQB, the increase of its clinical trial sample size and the completion of its point of care (PoC) kits and applications. This is on top of the continued development of its strategic partnerships in the US and internationally.

“We want to demonstrate to US investors that we are really a North American company, not just Canadian,” says Ahmed.

BioMark is already generating revenues from its technology, selling some of its systems late last year to a company in the US involved with biophotonics, which can be described as the development and application of optical techniques, particularly imaging, to the study of biological molecules, cells and tissue. The company will capitalize on this application and present its technology at an industry conference in San Francisco, where it hopes to pick up more buyers.

“If researchers like it, this moves us into the lab and once we have a user base, it will be much easier to move into the mainstream. We will keep pushing for revenue generation, collaborate with strategic partners and build new distribution agreements around the world.”

With $250,000 in the bank, $750,000 in proceeds to close shortly from a financing round, and another $3 million to $5 million expected within the next four months, the company is well positioned to advance its commercialization strategies and deliver on an exciting 2015.
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