Investment Highlights

BioMark is a leader in the next generation of cancer diagnostics.

early stage cancer detection - BioMark Diagnostics we believe cancer can be cured
early stage cancer detection - BioMark Diagnostics we believe cancer can be cured

Leadership

BioMark Investment Highlights

BioMark Diagnostics Inc. is a leader in next-generation cancer diagnostics using metabolites. The Company is developing proprietary, non-invasive, highly accurate solutions to cost-effectively detect cancer in its very early stages, when most cancers can be cured. BioMark is also developing diagnostics that can be used to increase the uptake of lung cancer screening using Low Dose CT, measuring a patient’s response to treatment and for the ongoing monitoring of cancer survivors. The Company’s initial focus beyond a general cancer red alert tool is on diagnostics for lung cancer, with plans to expand into breast, pancreatic, thyroid and glioblastoma cancers.

CSE Symbol: BUX | FSE Symbol: 20B | OTCMKTS Symbol: BMKDF

biomark diagnostics investment overview

Market Focus

Target Market Focus for the Current Assays

Lung Cancer Metabolite Panel – Early detection of lung cancer in high-risk population and to complement Low dose CT screening for lung cancer screening.

At Risk Population For Lung Cancer Screening

In March, 2021, the United States Preventive Services Task Force (USPSTF) updated their lung cancer screening guidelines.

To be eligible for a yearly lung cancer screening with no out-of-pocket expenses, at risk person is defined as:

  • must be between 50-77 years of age
  • must not have signs or symptoms of lung cancer
  • must be a current smoker or have quit within 15 years
  • must have smoked an average of one pack (20 cigarettes) per day for 20 years
  • must have an order from a doctor

 

Estimated Market Size: 16 million in USA and 1.8 million in Canada. Currently there is less than 6% uptake in lung cancer screening due to the high rates of false negatives and access to LD CT scan  

Liquid Biopsy Assay For Early Stage Lung Cancer

BioMark Diagnostics has over the past 3 years invested and successfully developed a liquid biopsy based metabolic panel assay that has been validated and is highly robust . The assay has clinically demonstrated superior detection capabilities for early stage 1 and 2 lung cancers plasma. This is a major breakthrough in molecular cancer diagnostics and strategically positions the company in a vintage position for high-risk lung cancer screening market which currently uses low dose CT scans (LDCT). BioMark’s assays have the following merits compared to existing LDCT test:

  • Use BioMark’s assay is cost effective
  • Potentially reduce false positives and negatives associated with LDCT Scans
  • Can use as routine test
  • Following patients with abnormalities that are difficult to confirm using CT scans
liquid biopsy chart

False Positive: Telling someone they have a disease, but they don’t actually have it
False Negative: Telling someone they do not have a disease, but they actually do
Specificity: Ability of the test to correctly identify those without the disease (true negative rate)
Sensitivity: Ability of a test to correctly identify those with a disease (true positive rate)

The lung cancer metabolites are easily measured using quantitative mass spectrometry (MS) methods with standard instruments used in diagnostic clinical laboratories across Canada and USA.

  • the amount of blood required (<20 µL),
  • the expected cost per test ($100)
  • the expected revenue per test ($350)
  • the time to perform the test (<5 minutes on an MS instrument and LDTD proprietary platform)

 

BioMark intends to have a lab developed test commercialized within 12-18 months

BioMark's SSAT1 Legacy Assay

  • BioMark’s initial assay detects SSAT1, an enzyme with elevated levels in numerous cancers, using an FDA approved drug. The assay targets a well researched metabolic pathway. This assay (SSAT1) can be used as a non-invasive, cost-effective red alert tool for physicians globally
  • BioMark has completed a comprehensive trial and is currently assembling a submission package to Health Canada for market approval for this test which physicians can use as a screening test and help to assess the need for more definitive imaging or molecular test. To further support the submission BioMark has 2 peer reviewed publication (PubMed) and intends to publish and present other papers throughout 2019
Applications

a. BioMark’s assay will be used to predict response and outcome of systemic therapy for patients on chemotherapy, immunotherapy, and radiotherapy treatment in late-stage lung cancer.

How? Determine concurrence to SSAT1 concentration in urine or plasma.

Status -Conducted a successful pilot study and published a peer reviewed paper in Feb 2021

Next Steps: Increase patient numbers at additional sites

Positive results impact:

        • Modify / Personalize treatment for patients earlier
        • Reduce costs associated with expensive therapies with an annual cost estimated at about $100K / patient
        • Positively impact quality of life for patients

b. Use of SSAT 1 For GBM – measure response to treatment and recurrence

The use of SSAT 1 based biomarkers to assess surgical resection and determine potential physiological and anatomical correlation as a guide and complimentary tool to existing procedure.

Health Canada Trial Approved and the study is on going at CancerCare Manitoba

About GBM

Glioblastoma is the most common primary malignant form of brain cancerDespite technological advances in surgery and radio-chemotherapy, glioblastoma remains largely resistant to treatment. The standard treatment for glioblastoma is surgery. The choice of drug therapy for glioblastoma is still limited to a handful of compounds. There is over 90% recurrence rate.

BioMark’s Value Proposition

Develop better diagnostic tools to assess progression and response to treatment. No paradigm shift for many years

BioMark secured federal government funding to support clinical research – $875K

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early stage cancer detection - BioMark Diagnostics we believe cancer can be cured
early stage cancer detection - BioMark Diagnostics we believe cancer can be cured

© 2021 BioMark Diagnostics Inc. All Rights Reserved. BioMark’s mission is to provide universal access to a new paradigm in cancer diagnostics using metabolomics.